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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/NCT01902290
Registration number
NCT01902290
Ethics application status
Date submitted
22/05/2013
Date registered
18/07/2013
Date last updated
21/09/2022
Titles & IDs
Public title
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
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Scientific title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility
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Secondary ID [1]
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2012-003351-11
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Secondary ID [2]
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20120141
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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 - Brodalumab
Placebo Comparator: Placebo - Participants received placebo administered by subcutaneous injection on day 1, week 1, week 2 and every 2 weeks thereafter for 24 weeks.
Experimental: Brodalumab 210 mg - Participants received 210 mg brodalumab administered by subcutaneous injection on day 1, week 1, week 2, and every 2 weeks thereafter for 24 weeks.
Other interventions: Placebo
Placebo administered subcutaneously
Other interventions: Brodalumab
Brodalumab administered subcutaneously
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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 Asthma Control Questionnaire (ACQ) Composite Score at Week 24
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Assessment method [1]
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The ACQ is a validated instrument used in clinical research and practice to evaluate asthma control/impairment.
The ACQ assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon wakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and FEV1. All seven items are scored on a 7-point scale, with 0 indicating good control and 6 indicating poor control; the total score is the mean of the seven items and ranges from 0 (totally-controlled) to 6 (extremely poorly controlled). A negative change from baseline indicates improvement. A change of 0.50 points is considered clinically meaningful and a total score of < 1.0 indicates good asthma control.
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Timepoint [1]
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Baseline and week 24
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Secondary outcome [1]
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Asthma Exacerbation Rate
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Assessment method [1]
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The asthma exacerbation event rate is defined as the number of events per subject-year during the 24 week treatment period. An asthma exacerbation was defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study; distinct asthma exacerbations were defined as events with start dates more than 10 days apart from each other.
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Timepoint [1]
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Baseline to week 24
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Secondary outcome [2]
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Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation
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Assessment method [2]
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The ACQ is a validated instrument used in clinical research and practice to evaluate asthma control/impairment.
The ACQ assesses disease control by evaluating 7 questions: night time awakenings, asthma symptoms upon wakening, activity limitation, shortness of breath, wheeze frequency, short-acting bronchodilator use, and FEV1. All seven items are scored on a 7-point scale, with 0 indicating good control and 6 indicating poor control; the total score is the mean of the seven items and ranges from 0 (totally-controlled) to 6 (extremely poorly controlled). A negative change from baseline indicates improvement. A change of 0.50 points is considered clinically meaningful and a total score of < 1.0 indicates good asthma control.
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Timepoint [2]
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Baseline and week 24
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Secondary outcome [3]
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Asthma Exacerbation Rate in ICS+LABA Subpopulation
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Assessment method [3]
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The asthma exacerbation event rate is defined as the number of events per subject-year during the 24 week treatment period. An asthma exacerbation was defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study; distinct asthma exacerbations were defined as events with start dates more than 10 days apart from each other.
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Timepoint [3]
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Baseline to week 24
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Secondary outcome [4]
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Change From Baseline in Daily Asthma Symptom Score (7-day Average Score)
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Assessment method [4]
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The Asthma Symptom Diary (ASD) consists of 23 questions answered on a handheld device, including 10 asthma symptom-related items (5 answered in the morning and 5 in the evening).
The morning diary comprises questions on 4 asthma-related symptoms (wheezing, shortness of breath, cough, chest tightness), rated on a 5-point severity scale from 0 (no symptom) to 4 (very severe symptoms), and 1 question on nocturnal awakenings, rated from 0 (did not wake up) to 4 (unable to sleep due to asthma). The evening diary has questions on the same 4 asthma-related symptoms and 1 question on limitations of activities, rated from 0 (not at all) to 4 (extremely).
The ASD daily score is computed by averaging the responses to the 10 symptom-related items, and the mean 7-day ASD score is calculated by averaging the 7 daily scores, with the final score ranging from 0 (minimal symptoms) to 4 (very severe symptoms).
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Timepoint [4]
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Baseline and week 24
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Secondary outcome [5]
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Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1)
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Assessment method [5]
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Timepoint [5]
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Baseline and week 24
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Secondary outcome [6]
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Change From Baseline in Daily Rescue Short-acting Beta-agonist Use
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Assessment method [6]
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Participants were permitted allowed to use their inhaled rescue medication (SABA) as needed throughout the study and the use was captured in the daily electronic diary (eDiary).
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Timepoint [6]
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Baseline and week 24
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Secondary outcome [7]
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Time to First Asthma Exacerbation
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Assessment method [7]
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An asthma exacerbation is defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study. Median time to first asthma exacerbation could not be estimated, the percentage of participants with an asthma exacerbation is reported.
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Timepoint [7]
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From first dose of study drug to week 24
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Secondary outcome [8]
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Number of Participants Who Experienced an Asthma Exacerbation
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Assessment method [8]
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An asthma exacerbation is defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study.
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Timepoint [8]
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Baseline to week 24
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Secondary outcome [9]
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Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score
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Assessment method [9]
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The AQLQ is an asthma-specific instrument that includes evaluations of both symptoms and health-related quality of life measures. The 32-item instrument measures 4 domains affected by asthma including activity limitations, emotional function, exposure to environmental stimuli, and symptoms.
Participants were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (7=no impairment, 1=severe impairment). The overall score was calculated as mean of the responses to the 32 questions and ranges from 1 (severe impairment) to 7 (no impairment). A positive change from baseline indicates improvement.
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Timepoint [9]
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Baseline and week 24
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Secondary outcome [10]
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Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR)
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Assessment method [10]
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Peak expiratory flow rate was measured by the participant twice daily at approximately the same time each day (eg, within 1 hour of waking and immediately before bedtime) using a peak flow meter.
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Timepoint [10]
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Baseline and week 24
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Secondary outcome [11]
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Change From Baseline in Variation of Peak Flow
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Assessment method [11]
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Peak flow was measured by the participant twice daily at approximately the same time each day (eg, within 1 hour of waking and immediately before bedtime) using a peak flow meter. The variation of peak flow is defined as the absolute value of the difference between the A.M. and P.M. peak flow in one day for an individual participant.
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Timepoint [11]
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Baseline and week 24
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Secondary outcome [12]
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Proportion of Asthma Symptom-free Days in 4-weeks Intervals Over the Treatment Period
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Assessment method [12]
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Asthma symptom-free days is defined as days that a participant had a score of zero in their daily asthma symptom diary score.
The ASD consists of 23 questions answered on a handheld device, including 10 asthma symptom-related items (5 answered in the morning and 5 in the evening).
The morning diary comprises questions on 4 asthma-related symptoms (wheezing, shortness of breath, cough, chest tightness), rated on a 5-point severity scale from 0 (no symptom) to 4 (very severe symptoms), and 1 question on nocturnal awakenings, rated from 0 (did not wake up) to 4 (unable to sleep due to asthma). The evening diary has questions on the same 4 asthma-related symptoms and 1 question on limitations of activities, rated from 0 (not at all) to 4 (extremely).
The daily score is the average of the responses to the 10 items.
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Timepoint [12]
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Baseline (the 4 weeks prior to first dose) and 4-week intervals up to week 24
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Secondary outcome [13]
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Serum Brodalumab Concentration
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Assessment method [13]
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Serum brodalumab concentrations were measured using an enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) = 0.0500 µg/mL; values below the LLOQ were set to zero.
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Timepoint [13]
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Day 1 and weeks 1, 2, 4, 8, 12, 16, and 22 at predose, week 2 + 3 days, week 22 + 3, 7, 10, and 14 days
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Eligibility
Key inclusion criteria
- Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced
expiratory volume in 1 second (FEV1) of = 20% at screening
- Percent of predicted FEV1 = 40% and = 80% at screening
- Inhaled corticosteroid (ICS) = 200 and = 1000/µg/day fluticasone powder or equivalent
- Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at
screening and baseline = 1.5 points
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Minimum age
18
Years
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Maximum age
75
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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
- History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary
condition other than asthma
- History of allergic bronchopulmonary aspergillosis
- Respiratory infection within 4 weeks of screening or 1 week of baseline visit
- Subject has known history of Crohn's disease
- Subject has any other significant concurrent medical condition of laboratory
abnormalities, as defined in the study protocol
- Subject has previously used any anti-interleukin-17 (IL17) biologic therapy
- Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in
the study
- Female subject is unwilling to use highly effective methods of birth control unless 2
years post-menopausal or surgically sterile
- Subject has severe depression measured by Personal Health Questionnaire Depression
Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide
Severity Rating Scale (e-CSSRS)
- Subject has a history or evidence of psychiatric disorder or substance abuse
considered by the Investigator to pose a risk to subject safety
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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 administering the treatment/s
The people assessing the outcomes
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
22/05/2013
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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
15/05/2015
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Sample size
Target
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Accrual to date
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Final
421
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Research Site - New Lambton
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Recruitment hospital [2]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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2305 - New Lambton
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
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Cork
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Italy
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Italy
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Padova
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Italy
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Italy
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Tradate (VA)
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Korea, Republic of
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Bucheon-si, Gyeonggi-do
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Korea, Republic of
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Incheon
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Seoul
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Wonju-si, Gangwon-do
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Zgierz
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Kyowa Kirin Co., Ltd.
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Commercial sector/Industry
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AstraZeneca
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Summary
Brief summary
The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective
compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite
scores.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01902290
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Trial related presentations / publications
Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019 Apr 3;3(1):22. doi: 10.1186/s41687-019-0109-2.
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Public notes
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Contacts
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Amgen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01902290
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