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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/NCT01128595
Registration number
NCT01128595
Ethics application status
Date submitted
20/05/2010
Date registered
24/05/2010
Date last updated
18/01/2017
Titles & IDs
Public title
Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response
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Scientific title
A Randomised, Double-blind, Placebo-controlled, Four-way Crossover, Repeat Dose Study Comparing the Effect of Inhaled Fluticasone Furoate/GW642444M Combination, GW642444M and Fluticasone Furoate on the Allergen-induced Asthmatic Response in Subjects With Mild Asthma
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Secondary ID [1]
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113126
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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
Treatment: Drugs - FF/GW642444M
Treatment: Drugs - GW642444M
Treatment: Drugs - Fluticasone Furoate
Treatment: Drugs - Placebo
Active Comparator: ICS -
Active Comparator: ICS/LABA -
Active Comparator: LABA -
Placebo Comparator: Placebo -
Treatment: Drugs: FF/GW642444M
Treatment: Drugs: GW642444M
Treatment: Drugs: Fluticasone Furoate
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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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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Late Asthmatic Response (LAR): Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
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Assessment method [1]
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Forced expiratory volume in one second (FEV1) is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen (administered by inhalation) 1 hr after dosing on Day 21. Minimum FEV1 over 4-10 hours post-allergen challenge (minimum LAR) is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
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Timepoint [1]
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Day 21 of each treatment period (up to Study Day 197)
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Primary outcome [2]
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LAR: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
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Assessment method [2]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hour after dosing on Day 21. LAR FEV1 was measured 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 21. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
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Timepoint [2]
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Day 21 of each treatment period (up to Study Day 197)
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Primary outcome [3]
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Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
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Assessment method [3]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs. Absolute change from saline in minimum FEV1 was calculated as the minimum FEV1 minus the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value. Least squares means were obtained by adjusting for period and participant and period Baselines.
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Timepoint [3]
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Day 21 of each treatment period (up to Study Day 197)
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Primary outcome [4]
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EAR: Absolute Change From Saline in Weighted Mean FEV1 Between 0-2 Hrs Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
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Assessment method [4]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. The EAR FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Least squares means were obtained by adjusting for period and participant and period Baselines. Absolute change from saline in WM FEV1 was calculated as the area under the curve divided by the relevant time interval and subtracting the saline FEV1 value. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.
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Timepoint [4]
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Day 21 of each treatment period (up to Study Day 197)
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Secondary outcome [1]
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Maximum Percent Change From Saline in FEV1 Between 0-2 Hrs, Following the 1-hr Post-treatment Allergen Challenge on Day 21 of Each Treatment Period
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Assessment method [1]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 1 hr after dosing on Day 21. FEV1 was measured 0 minutes (min), 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 1 hr, 1.5 hrs, and 2 hrs post-allergen challenge on Day 21. Maximum percent change was calculated as the minimum FEV1 minus the saline FEV1 value divided by the saline FEV1 multiplied by 100. After inhalation of saline, 3 single measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline FEV1 value.
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Timepoint [1]
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Day 21 of each treatment period (up to Study Day 197)
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Secondary outcome [2]
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Provocative Concentration of Methacholine Estimated to Result in a 20% Reduction in FEV1 (PC20) on Day 22 of Each Treatment Period
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Assessment method [2]
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants inhaled doubling increments of methacholine until a >=20% fall in FEV1 from the saline value was achieved. After inhalation of saline, 3 measurements of FEV1 were recorded; the maximum FEV1 value was taken as the saline value.
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Timepoint [2]
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Day 22 of each treatment period (up to Study Day 198)
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Eligibility
Key inclusion criteria
- Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).
- Females of non-child bearing potential.
- Documented history of bronchial asthma, first diagnosed at least 6 months prior to the
screening visit and currently being treated only with intermittent short-acting beta
-agonist therapy by inhalation
- Pre-bronchodilator FEV1 >70% of predicted at screening
- Subjects who are current non-smokers
- Methacholine challenge PC20 < 8 mg/mL at screening
- Screening allergen challenge demonstrates that the subject experiences an early
asthmatic response
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Minimum age
18
Years
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Maximum age
65
Years
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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
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Subject is hypertensive at screening
- Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to
the first dose of study medication.
- History of life-threatening asthma
- Symptomatic with hay fever at screening or predicted to have symptomatic hayfever
- Unable to abstain from short acting beta agonists
- Unable to abstain from antihistamines
- Unable to abstain from other medications including non-steroidal
anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma
anti-rhinitis or hay fever medication
- The subject has participated in a study with a new molecular entity during the
previous 3 months or has participated in 4 or more clinical studies in the
previous 12 months
- undergoing allergen desensitisation therapy
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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
Crossover
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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
Completed
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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
1/05/2010
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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
1/05/2011
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Sample size
Target
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Accrual to date
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Final
27
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GSK Investigational Site - Randwick
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Wellington
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Country [2]
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Sweden
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State/province [2]
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Göteborg
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Country [3]
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Sweden
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State/province [3]
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Lund
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
We propose to use an inhaled allergen challenge model to explore the individual contributions
of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination
product and its components on protection from allergic triggers in asthma
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01128595
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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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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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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
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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/NCT01128595
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