Trial · NCT01902290
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
NCT01902290, Phase 2, Terminated, Amgen; results first posted 2022-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility. Trials, record NCT01902290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01902290
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
- NCT number
- NCT01902290
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 421 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Asthma
- Interventions
- Placebo, Brodalumab
- First posted
- 2013-07-18
- Last updated
- 2022-09-21
- Other registries' IDs
- eudract:2012-003351-11
- Results first posted
- 2022-02-28
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24 | Baseline and week 24 | 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. |
| Secondary | Asthma Exacerbation Rate | Baseline to week 24 | 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. |
| Secondary | Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation | Baseline and week 24 | 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. |
| Secondary | Asthma Exacerbation Rate in ICS+LABA Subpopulation | Baseline to week 24 | 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. |
| Secondary | Change From Baseline in Daily Asthma Symptom Score (7-day Average Score) | Baseline and week 24 | 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). |
| Secondary | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Baseline and week 24 | |
| Secondary | Change From Baseline in Daily Rescue Short-acting Beta-agonist Use | Baseline and week 24 | 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). |
| Secondary | Time to First Asthma Exacerbation | From first dose of study drug to week 24 | 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. |
| Secondary | Number of Participants Who Experienced an Asthma Exacerbation | Baseline to week 24 | An asthma exacerbation is defined as an asthma worsening that requires systemic corticosteroids for at least 3 days during the study. |
| Secondary | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score | Baseline and week 24 | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24 | Baseline and week 24 | Full analysis set with available data | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Asthma Exacerbation Rate | Baseline to week 24 | Full analysis set with available data | exacerbations per subject-year | NUMBER |
| SECONDARY | Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation | Baseline and week 24 | Full analysis set participants who were taking both inhaled corticosteroids (ICS) and a long-acting β-agonist (LABA) at baseline with available data. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Asthma Exacerbation Rate in ICS+LABA Subpopulation | Baseline to week 24 | Full analysis set participants taking both ICS and LABA at baseline with available data | exacerbations per subject-year | NUMBER |
| SECONDARY | Change From Baseline in Daily Asthma Symptom Score (7-day Average Score) | Baseline and week 24 | Full analysis set with available data | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) | Baseline and week 24 | Full analysis set with available data | L/s | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daily Rescue Short-acting Beta-agonist Use | Baseline and week 24 | Full analysis set with available data | puffs | LEAST_SQUARES_MEAN |
| SECONDARY | Time to First Asthma Exacerbation | From first dose of study drug to week 24 | Full analysis set with available data | percentage of participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Asthma Exacerbation | Baseline to week 24 | Full analysis set with available data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Overall Score | Baseline and week 24 | Full analysis set with available data | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group77
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24 | Placebo | -0.815 | Standard Error 0.073 | score on a scale | |
| Change From Baseline in Asthma Control Questionnaire (ACQ) Composite Score at Week 24 | Brodalumab 210 mg | -0.865 | Standard Error 0.074 | score on a scale | |
| Asthma Exacerbation Rate | Placebo | 0.57 | exacerbations per subject-year | ||
| Asthma Exacerbation Rate | Brodalumab 210 mg | 0.81 | exacerbations per subject-year | ||
| Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation | Placebo | -0.793 | Standard Error 0.084 | score on a scale | |
| Change From Baseline in ACQ Composite Score at Week 24 in ICS+LABA Subpopulation | Brodalumab 210 mg | -0.831 | Standard Error 0.088 | score on a scale | |
| Asthma Exacerbation Rate in ICS+LABA Subpopulation | Placebo | 0.60 | exacerbations per subject-year | ||
| Asthma Exacerbation Rate in ICS+LABA Subpopulation | Brodalumab 210 mg | 0.89 | exacerbations per subject-year | ||
| Change From Baseline in Daily Asthma Symptom Score (7-day Average Score) | Placebo | -0.397 | Standard Error 0.042 | score on a scale | |
| Change From Baseline in Daily Asthma Symptom Score (7-day Average Score) | Brodalumab 210 mg | -0.443 | Standard Error 0.043 | score on a scale |
1 to 10 of 77Source ClinicalTrials.gov
See all 77 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 210 | |
| Overall Study | STARTED | Brodalumab 210 mg | 211 | |
| Overall Study | Received Study Drug | Placebo | 207 | |
| Overall Study | Received Study Drug | Brodalumab 210 mg | 208 | |
| Overall Study | COMPLETED | Placebo | 162 | |
| Overall Study | COMPLETED | Brodalumab 210 mg | 158 | |
| Overall Study | NOT COMPLETED | Placebo | 48 | |
| Overall Study | NOT COMPLETED | Brodalumab 210 mg | 53 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 207 | |
| other | Nausea | Gastrointestinal disorders | Brodalumab 210 mg | 6 | 208 | |
| other | Fatigue | General disorders | Placebo | 5 | 207 | |
| other | Fatigue | General disorders | Brodalumab 210 mg | 2 | 208 | |
| other | Injection site erythema | General disorders | Placebo | 3 | 207 | |
| other | Injection site erythema | General disorders | Brodalumab 210 mg | 6 | 208 | |
| other | Bronchitis | Infections and infestations | Placebo | 14 | 207 | |
| other | Bronchitis | Infections and infestations | Brodalumab 210 mg | 13 | 208 | |
| other | Influenza | Infections and infestations | Placebo | 1 | 207 | |
| other | Influenza | Infections and infestations | Brodalumab 210 mg | 8 | 208 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Brodalumab 210 mg | ||
| Total, other adverse events | Placebo | 104 | 207 |
| Total, other adverse events | Brodalumab 210 mg | 129 | 208 |
| Total, serious adverse events | Placebo | 8 | 207 |
| Total, serious adverse events | Brodalumab 210 mg | 7 | 208 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30945020 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brodalumab 210 mg vs Placebo: Number of Participants Who Experienced an Asthma Exacerbation | Trial comparisons |
| Brodalumab 210 mg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01902290/results?page=2