Trial · NCT03218917
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
NCT03218917, Phase 2, Completed, Insmed Incorporated; results first posted 2023-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis. Trials, record NCT03218917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03218917
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
- NCT number
- NCT03218917
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 256 participants, actual
- Lead sponsor
- Insmed Incorporated
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Interventions
- Brensocatib 10 mg, Brensocatib 25 mg, Placebo
- First posted
- 2017-07-17
- Last updated
- 2023-03-27
- Other registries' IDs
- eudract:2017-002533-32
- Results first posted
- 2023-02-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period | Baseline (Day 1) to Week 24 | Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis A minimum of 4 weeks must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 4 weeks from the prior exacerbation was not considered a new exacerbation. The analysis was performed using the stratified log rank test and using Kaplan Meier (KM) curves. |
| Secondary | Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period | Baseline (Day 1) to Week 24 | The QOL-B is a validated, self-administered patient reported outcome (PRO) that assesses symptoms, functioning, and health-related (HR) QOL for participants with non-cystic fibrosis bronchiectasis (NCFBE). The QOL-B contains 37 items in 8 domains (Respiratory Symptoms, Physical Functioning, Role Functioning, Emotional Functioning, Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each of the 37 items is scored from 1 to 4, and each of the 8 domains scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and HR QoL. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported. The analysis was based on mixed model for repeated measures (MMRM) approach. |
| Secondary | Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period | Screening (Days -42 to -1) to Week 24 | FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath. The percent predicted FEV1 was calculated by converting the spirometer reading to a percentage of what would be predicted as normal FEV1 based on a several personal factors (e.g. sex, age, etc.). Change from screening in percent predicted FEV1 to Week 24 was calculated as: percent predicted FEV1 value at Week 24 and percent predicted FEV1 value at screening. A positive percent change from screening indicates an improvement in lung function. The analysis was done using analysis of covariance (ANCOVA) with Pa colonization status and maintenance macrolide antibiotic use at Baseline as covariates. |
| Secondary | Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum | Baseline (Day 1) to Week 24 | The concentration of active NE in sputum, was measured by the difference between the pre-treatment concentration and on-treatment concentration. In bronchiectasis, activation of neutrophils in the airway leads to release of NE which leads to damaged airway walls, mucus hypersecretion, exacerbated inflammation, which in turn affects neutrophil and macrophage functions, increasing the risk of infection. Negative change from Baseline indicates improvement. |
| Secondary | Number of Participants Who Experienced a Pulmonary Exacerbation | Baseline (Day 1) to Week 24 | Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics. 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis A minimum of 4 weeks must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 4 weeks from the prior exacerbation was not considered a new exacerbation. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period | Baseline (Day 1) to Week 24 | ITT population included all participants who were randomized. Overall number of participants analyzed are number of participants with at least one exacerbation over 24-week treatment period. | days | MEDIAN |
| SECONDARY | Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period | Baseline (Day 1) to Week 24 | ITT population included all participants who were randomized. Overall number of participants analyzed are the number of participants with data available for analyses at the latest assessment visit over the 24-week treatment period. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period | Screening (Days -42 to -1) to Week 24 | ITT population included all participants who were randomized. Overall number of participants analyzed are the number of participants with data available for analyses over the 24-week treatment period. | percent predicted FEV1 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum | Baseline (Day 1) to Week 24 | Pharmacodynamic population included participants who received at least 1 dose of the study drugs, have at least 1 pre-dose and 1 post-dose measurement for NE, or proteinase 3, or cathepsin G, or other biomarkers, and have no major protocol deviations that considered to impact on the analysis of the PD data. | microgram/ milliliter (µg/mL) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Experienced a Pulmonary Exacerbation | Baseline (Day 1) to Week 24 | ITT population included all participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period | Brensocatib 10 mg | NA | 90% Confidence Interval NA to NA | days | |
| Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period | Brensocatib 25 mg | NA | 90% Confidence Interval NA to NA | days | |
| Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period | Placebo | 189.0 | 90% Confidence Interval 141.0 to NA | days | |
| Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period | Brensocatib 10 mg | 3.8 | Standard Error 0.78 | score on a scale | |
| Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period | Brensocatib 25 mg | 5.9 | Standard Error 0.76 | score on a scale | |
| Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period | Placebo | 5.7 | Standard Error 0.77 | score on a scale | |
| Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period | Brensocatib 10 mg | -0.3 | Standard Error 0.88 | percent predicted FEV1 | |
| Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period | Brensocatib 25 mg | -0.3 | Standard Error 0.85 | percent predicted FEV1 | |
| Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period | Placebo | -1.8 | Standard Error 0.87 | percent predicted FEV1 | |
| Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum | Brensocatib 10 mg | -2.928 | Standard Error 0.351 | microgram/ milliliter (µg/mL) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brensocatib 10 mg | 82 | |
| Overall Study | STARTED | Brensocatib 25 mg | 87 | |
| Overall Study | STARTED | Placebo | 87 | |
| Overall Study | Received Study Treatment (Safety Population) | Brensocatib 10 mg | 81 | |
| Overall Study | Received Study Treatment (Safety Population) | Brensocatib 25 mg | 89 | |
| Overall Study | Received Study Treatment (Safety Population) | Placebo | 85 | |
| Overall Study | Participants Did Not Receive Drug | Brensocatib 10 mg | 0 | |
| Overall Study | Participants Did Not Receive Drug | Brensocatib 25 mg | 0 | |
| Overall Study | Participants Did Not Receive Drug | Placebo | 1 | |
| Overall Study | Pharmacodynamic (PD) Population | Brensocatib 10 mg | 80 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events120
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 | Diarrhoea | Gastrointestinal disorders | Brensocatib 10 mg | 5 | 81 | |
| other | Diarrhoea | Gastrointestinal disorders | Brensocatib 25 mg | 3 | 89 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 9 | 85 | |
| other | Periodontal disease | Gastrointestinal disorders | Brensocatib 10 mg | 2 | 81 | |
| other | Periodontal disease | Gastrointestinal disorders | Brensocatib 25 mg | 5 | 89 | |
| other | Periodontal disease | Gastrointestinal disorders | Placebo | 0 | 85 | |
| other | Fatigue | General disorders | Brensocatib 10 mg | 3 | 81 | |
| other | Fatigue | General disorders | Brensocatib 25 mg | 7 | 89 | |
| other | Fatigue | General disorders | Placebo | 6 | 85 | |
| other | Upper respiratory tract infection | Infections and infestations | Brensocatib 10 mg | 6 | 81 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brensocatib 10 mg | 0 | 81 |
| Total, all-cause mortality | Brensocatib 25 mg | 1 | 89 |
| Total, all-cause mortality | Placebo | 0 | 85 |
| Total, other adverse events | Brensocatib 10 mg | 47 | 81 |
| Total, other adverse events | Brensocatib 25 mg | 43 | 89 |
| Total, other adverse events | Placebo | 33 | 85 |
| Total, serious adverse events | Brensocatib 10 mg | 11 | 81 |
| Total, serious adverse events | Brensocatib 25 mg | 10 | 89 |
| Total, serious adverse events | Placebo | 19 | 85 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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