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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00640016
Registration number
NCT00640016
Ethics application status
Date submitted
13/03/2008
Date registered
20/03/2008
Date last updated
31/01/2017
Titles & IDs
Public title
A Study to Assess the Efficacy, Safety, and Tolerability of CAT-354 in Subjects With Asthma
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Scientific title
A Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of CAT-354
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Secondary ID [1]
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2007-002090-31
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Secondary ID [2]
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CAT-354-0603
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Placebo
Other interventions - CAT-354 1 mg/kg
Other interventions - CAT-354 5 mg/kg
Other interventions - CAT-354 10 mg/kg
Placebo Comparator: Placebo - Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
Experimental: CAT-354 1 mg/kg - CAT-354 1 milligram per kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Experimental: CAT-354 5 mg/kg - CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Experimental: CAT-354 10 mg/kg - CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56
Other interventions: Placebo
Placebo matched to CAT-354 intravenous infusion over 60 minutes on Day 0, 28 and 56.
Other interventions: CAT-354 1 mg/kg
CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Other interventions: CAT-354 5 mg/kg
CAT-354 5 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
Other interventions: CAT-354 10 mg/kg
CAT-354 10 mg/kg of body weight intravenous infusion over 60 minutes on Day 0, 28 and 56.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Doubling Concentration of Methacholine at Day 28
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Assessment method [1]
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Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 milligram/kilogram [mg/kg]) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
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Timepoint [1]
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Baseline and Day 28
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Secondary outcome [1]
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Change From Baseline in Doubling Concentration of Methacholine at Day 56, 84 or Early Termination
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Assessment method [1]
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Change in doubling concentrations of methacholine was calculated as Log2 PC20 (Visit x) - Log2 PC20 (Baseline), where x was the post-baseline assessment (Day 28) and PC20 was provocative concentration of methacholine causing 20 percent fall in forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Change in doubling concentration was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
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Timepoint [1]
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Baseline, Day 56, 84 or early termination (any time before Day 84)
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Secondary outcome [2]
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Forced Expiratory Volume in 1 Second (FEV1)
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Assessment method [2]
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The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
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Timepoint [2]
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Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)
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Secondary outcome [3]
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Forced Vital Capacity (FVC)
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Assessment method [3]
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The FVC was volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
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Timepoint [3]
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Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, 63, 84 or early termination (any time before Day 84)
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Secondary outcome [4]
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Forced Expiratory Volume in 1 Second (FEV1) as Percentage of Forced Vital Capacity (FVC)
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Assessment method [4]
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Percentage of FEV1 was calculated as (FEV1/FVC)*100. It signified the percentage of the total amount of air exhaled from the lungs during the first second of forced exhalation. FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
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Timepoint [4]
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Predose, 30 minutes and 6 hours post-end of infusion on Day 0, 28 and 56; Day 4, 14, 35, Day 63, 84 or early termination (any time before Day 84)
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Secondary outcome [5]
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Asthma Control Questionnaire (ACQ) Total Score
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Assessment method [5]
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The ACQ is questionnaire that comprises of 7-questions evaluating participant's asthma control. Six self-administered questions assess asthma control over the past week covering nocturnal waking, morning symptoms, activity limitations, shortness of breath, wheezing, and short-acting bronchodilator use; using 7-point ordinal rating scale from 0 (good control) to 6 (poor control). Seventh question is completed by a health professional on forced expiratory volume in 1 second (FEV1) percentage (%) predicted; scale: 0 (greater than [>] 95% predicted) to 6 (less than [<] 50% predicted. Final score is the average score of the 7 questions, with a score range of 0 (well controlled) to 6 (extremely poor controlled). Result was summarized for sub-therapeutic dose (placebo and CAT-354 1 mg/kg) and therapeutic dose (CAT-354 5 mg/kg and CAT-354 10 mg/kg), as per planned analysis.
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Timepoint [5]
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Baseline, Day 28, 56, 84 or early termination (any time before Day 84)
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Secondary outcome [6]
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Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
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Assessment method [6]
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The FEV1 was maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.
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Timepoint [6]
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Day 0 to 84
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Secondary outcome [7]
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Number of Participants With Diary Data
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Assessment method [7]
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Participants recorded asthma symptoms, use of reliever inhalers (beta-agonist use for symptom relief and as prophylaxis), and morning and evening peak expiratory flow (PEF) measurements in a diary.
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Timepoint [7]
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Day 0, 4, 14, 28, 35, 56, 63 to Day and 84
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Secondary outcome [8]
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Number of Participants With Exacerbations
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Assessment method [8]
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Exacerbation was defined as: Mild (determined from diary data) - 2 consecutive days satisfying the same or 1 of the following criteria: any night with awakening(s) due to asthma or morning PEF 20 % or more below baseline where baseline = average of the 10 days before randomization or as-needed medication use of 2 inhalations or more in 24 hours above baseline where baseline = average of the 10 days before randomization. Severe (determined by taking an exacerbation update and history): deterioration of asthma resulting in emergency treatment or hospitalization or need for oral steroids for 3 days or more (as judged by the Investigator).
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Timepoint [8]
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Day 0 to Day 84
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Secondary outcome [9]
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Morning Peak Flow and Peak Flow Variability
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Assessment method [9]
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Peak flow is a participant's maximum speed of expiration.
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Timepoint [9]
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Day 0 to Day 84
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Secondary outcome [10]
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Adult Asthma Quality of Life (QoL) Questionnaire Final Score
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Assessment method [10]
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The AQLQ: a 32-item questionnaire evaluating quality of life of participants with asthma including 4 domains (symptoms, activity limitations, emotional function, and environmental stimuli). Participants are asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. The 4 domain scores are the means of the responses to the questions in each of the domains. Overall AQLQ score and 4 domain scores ranged from 7 (no impairment) to 1 (severe impairment).
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Timepoint [10]
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Day 0, 28, 84 or early termination (any time before Day 84)
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Secondary outcome [11]
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Maximum Observed Serum Concentration (Cmax) for CAT-354
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Assessment method [11]
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Timepoint [11]
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Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
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Secondary outcome [12]
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Minimum Observed Serum Concentration (Cmin) for CAT-354
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Assessment method [12]
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Timepoint [12]
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Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
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Secondary outcome [13]
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Area Under the Serum Concentration Time Curve From Time Zero to Last Measurable Concentration (AUC [0 - t]) for CAT-354
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Assessment method [13]
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Timepoint [13]
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Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
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Secondary outcome [14]
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Accumulation Ratio for CAT-354 (RA)
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Assessment method [14]
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Accumulation ratio (RA) is calculated for Cmax, Cmin and AUC as RA for Cmax = Cmax (56 - 84)/Cmax (0 - 28); Similarily, RA for Cmin = Cmin (56 - 84)/Cmin (0 - 28) and RA for AUC= AUC (56 - 84)/AUC (0 - 28) where Cmax (0 - 28) and Cmax (56 - 84) are the maximum observed serum concentration after first dose (Day 0 to Day 28) and after third dose (Day 56 to Day 84), respectively; Cmin (0 - 28) and Cmin (56 - 84) are the minimum observed serum concentration after first and third dose, respectively; AUC (0 - 28) and AUC (56 - 84) are the area under the serum concentration time curve over a dosage interval determined after first and third dose, respectively.
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Timepoint [14]
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Predose, 10 minutes and 6 hours post-end of infusion on Day 0, 28 and 56
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Secondary outcome [15]
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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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Assessment method [15]
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An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state.
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Timepoint [15]
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Day 0 to 84
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Eligibility
Key inclusion criteria
- Signed and dated written informed consent is obtained prior to any study related
procedure taking place
- Women either infertile (example [e.g.], hysterectomized, sterile or post-menopausal
with amenorrhea of least 1 year duration) or who are practicing an acceptable form of
birth control
- Uncontrolled (refractory) asthma despite treatment with a minimum dose of 800
microgram (mcg) beclomethasonedipropionate or equivalent inhaled corticosteroid per
day plus 1 or more additional controller, that is, long-acting beta-agonist,
leukotriene antagonist or theophylline. Oral corticosteroids (not parenteral) as
additional treatment at any dose are acceptable
- A forced expiratory volume in 1 second (FEV1) acceptable for airway
hyper-responsiveness (AHR) challenge tests (greater than 60 percent of predicted
normal) on the challenge days
- A provocative concentration of methacholine causing a 20 percent fall in FEV1 (PC20)
less than 4 milligram per milliliter (mg/mL)
- Aged 18-80 years
- A 12-lead electrocardiogram (ECG) with no-clinically significant abnormalities
- Clinical chemistry, hematology and urinalysis results within the laboratory reference
ranges or deemed not clinically significant by the Investigator
- Body weight of less than 130 kilogram (kg)
- No other clinically significant abnormality on history and clinical examination
- Able to comply with the requirements of the protocol.
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Experienced a severe exacerbation within 28 days preceding Day -28/-14 to Day 0
- Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Day -28/-14
to Day 0
- Subjects with a history of allergic rhinitis, seasonal allergy or esophagitis must be
optimally controlled and remain on a stable treatment regimen during the study
- Participation in another study within 5 half-lives or 3 months of the start of this
study, whichever is the longer
- Lower respiratory tract infection within 6 weeks of Day -28/-14 to Day 0
- Current smokers or ex-smokers with greater than 10 pack-years
- Blood donation (more than 550 mL) in the previous 2 months
- Excessive intake of alcohol (as judged by the Investigator) or evidence of drug or
solvent abuse
- Subjects with a physician-diagnosis of any other significant lung disease, including a
primary diagnosis of chronic obstructive pulmonary disease or bronchiectasis, or lung
cancer, sarcoidosis, tuberculosis, pulmonary fibrosis and cystic fibrosis
- Concurrent medication from Day -28/-14 to Day 0 (Screening visit) and for the duration
of the study with any of the prohibited medications
- Significant, uncontrolled disease including serious psychological disorders, chronic
renal failure, uncontrolled hypertension
- systolic blood pressure greater than 200 millimeters of mercury (mmHg), or diastolic
blood pressure greater than 100 mmHg, heart disease, psoriasis requiring treatment and
subjects who have had a heart attack or stroke within the 3 months preceding Day
-28/-14 to Day 0, or who have a known aneurysm
- Onset of uncontrolled seasonal allergy symptoms within 28 days preceding Day -28/-14
to Day 0
- Subjects with a history of allergic rhinitis, seasonal allergy or esophagitis must be
optimally controlled and remain on a stable treatment regimen during the study
- Any factor which, in the opinion of the Investigator, would jeopardize the evaluation
or safety or be associated with poor adherence to the protocol (that is, inability to
complete study diary, perform peak expiratory flow (PEF) measurements)
- The subject's primary care physician recommends the subject should not take part in
the study
- Known hypersensitivity to CAT-354 or its components, to the challenge agents used in
the study or to related drugs.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2008
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Sample size
Target
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Accrual to date
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Final
14
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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St. Vincents Hospital, Thoracic Medicine Unit - Darlinghurst
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Recruitment hospital [2]
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Respiratory Medicine Department, Mater Adult Hospital, - South Brisbane
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Recruitment hospital [3]
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Princess Alexandria Hospital, Dept of Respiratory Medicine - Woolloongabba
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Recruitment hospital [4]
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Eastern Clinical Research Unit - Box Hill
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Recruitment hospital [5]
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Monash Medical Centre, Dept Respiratory Medicine. - Clayton
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Recruitment hospital [6]
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Dep of Respiratory & Sleep Medicine, Western Hospital - Footscray
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Recruitment hospital [7]
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Respiratory & Sleep Medicine, Royal Melbourne Hospital - Parkville
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Recruitment hospital [8]
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Lung Institute WA, Sir Charles Gardner Hospital - Nedlands
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Recruitment hospital [9]
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WA Lung Research, Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3011 - Footscray
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Berlin
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Country [2]
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Germany
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State/province [2]
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Bonn
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Country [3]
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Germany
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State/province [3]
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Frankfurt
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Country [4]
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Germany
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State/province [4]
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Magdeburg
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Country [5]
0
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Germany
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State/province [5]
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Mainz
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Country [6]
0
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Germany
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State/province [6]
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Munster
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Country [7]
0
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Germany
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State/province [7]
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Rostock
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Country [8]
0
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Germany
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State/province [8]
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Treuenbrietzen
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Country [9]
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Netherlands
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State/province [9]
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Amsterdam
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Country [10]
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Poland
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State/province [10]
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Bialystok
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Country [11]
0
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Poland
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State/province [11]
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Katowice
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0
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Poland
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State/province [12]
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Kraków
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Country [13]
0
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Poland
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State/province [13]
0
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Lubin
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0
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Poland
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State/province [14]
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Lublin
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Country [15]
0
0
Poland
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State/province [15]
0
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Warszawa
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Country [16]
0
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Poland
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State/province [16]
0
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Zgierz
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Country [17]
0
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Poland
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State/province [17]
0
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Lódz
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Country [18]
0
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United Kingdom
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State/province [18]
0
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Belfast
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Country [19]
0
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United Kingdom
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State/province [19]
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Birmingham
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Country [20]
0
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United Kingdom
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State/province [20]
0
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Glasgow
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Country [21]
0
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United Kingdom
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State/province [21]
0
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Leicester
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Country [22]
0
0
United Kingdom
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State/province [22]
0
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London
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Country [23]
0
0
United Kingdom
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State/province [23]
0
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Manchester
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Country [24]
0
0
United Kingdom
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State/province [24]
0
0
Newcastle upon Tyne
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Country [25]
0
0
United Kingdom
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State/province [25]
0
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Newport
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Country [26]
0
0
United Kingdom
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State/province [26]
0
0
Norwich
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Country [27]
0
0
United Kingdom
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State/province [27]
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Stevenage, Hertfordshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
MedImmune LLC
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Cambridge Antibody Technology
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Address [1]
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0
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Country [1]
0
0
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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PRA Health Sciences
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
To investigate the effects of CAT-354 on airway hyper-responsiveness (AHR) in uncontrolled
asthma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00640016
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Thomas Mayer, M.D.
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Address
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PRA Health Sciences
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Country
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Phone
0
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Fax
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0
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Email
0
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Contact person for public queries
Name
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Address
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Country
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Phone
0
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00640016
Download to PDF