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Anti-inflammatory

Brensocatib for Bronchiectasis (ASPEN Trial)

Phase 3
Waitlist Available
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
a. Adolescent participants are required to have at least 1 pulmonary exacerbation in the prior 12 months.
Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (ie, methods that can achieve a failure rate <1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 weeks
Awards & highlights

ASPEN Trial Summary

This trial will test whether two doses of a new drug, brensocatib, can help to prevent pulmonary exacerbations (PEs), which are sudden worsening of symptoms in people with chronic lung disease.

Who is the study for?
This trial is for adolescents and adults with non-cystic fibrosis bronchiectasis, confirmed by CT scan, who've had at least one lung infection needing antibiotics in the past year. Participants must be able to consent and follow study procedures. Pregnant women or those of childbearing potential must use effective contraception.Check my eligibility
What is being tested?
The trial tests brensocatib's effectiveness at two doses (10 mg and 25 mg) versus a placebo in reducing lung infections over a year. It aims to see if brensocatib can lower the frequency of these exacerbations compared to not taking the drug.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience adverse reactions related to brensocatib or its components. These could range from mild symptoms like nausea or headaches to more severe issues depending on individual tolerance.

ASPEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a teenager and had at least one lung issue flare-up in the last year.
Select...
I am a woman who is postmenopausal, surgically sterile, or using highly effective birth control.
Select...
I have a lung condition confirmed by a CT scan, not related to cystic fibrosis.
Select...
I have a lung condition not caused by cystic fibrosis, confirmed by a CT scan.
Select...
I am a teenager and had at least one lung issue flare-up in the last year.

ASPEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Adjudicated Pulmonary Exacerbations (PEs)
Secondary outcome measures
Change From Baseline in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants
Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs)
+4 more

Side effects data

From 2019 Phase 2 trial • 256 Patients • NCT03218917
13%
Cough
13%
Headache
10%
Sputum increased
9%
Dyspnoea
8%
Fatigue
6%
Periodontal disease
4%
Sinusitis
4%
Upper respiratory tract infection
4%
Infective exacerbation of bronchiectasis
4%
Pneumonia
3%
Diarrhoea
2%
Haemoptysis
1%
Haemorrhoids
1%
Hypertension
1%
Arthralgia
1%
Respiratory failure
1%
Ventricular extrasystoles
1%
Intestinal obstruction
1%
Epistaxis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brensocatib 25 mg
Placebo
Brensocatib 10 mg

ASPEN Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Brensocatib 25 mgExperimental Treatment1 Intervention
Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
Group II: Brensocatib 10 mgExperimental Treatment1 Intervention
Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brensocatib 10 mg
2020
Completed Phase 3
~2030
Brensocatib 25 mg
2020
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
5,435 Total Patients Enrolled
4 Trials studying Bronchiectasis
2,320 Patients Enrolled for Bronchiectasis

Media Library

Brensocatib (Anti-inflammatory) Clinical Trial Eligibility Overview. Trial Name: NCT04594369 — Phase 3
Bronchiectasis Research Study Groups: Brensocatib 10 mg, Placebo, Brensocatib 25 mg
Bronchiectasis Clinical Trial 2023: Brensocatib Highlights & Side Effects. Trial Name: NCT04594369 — Phase 3
Brensocatib (Anti-inflammatory) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04594369 — Phase 3
Bronchiectasis Patient Testimony for trial: Trial Name: NCT04594369 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study still open to new participants?

"The trial is ongoing and has not yet met its patient quota. According to the latest update on clinicaltrials.gov, 100 sites are recruiting 1620 patients total."

Answered by AI

Is this a new kind of experiment?

"There have been 2 clinical trials for Brensocatib 25 mg in the past year, with 1620 participants total. The most recent study concluded its Phase 3 stage in 2020 and was sponsored by Insmed Incorporated. In total, 18292 studies on this medication have been completed since 2020."

Answered by AI

How many human participants are included in this research project?

"In order to complete this clinical trial, 1620 eligible patients must enroll. These participants can come from designated sites like USA081 in West Valley City, UT or USA115 in Hammond, IN."

Answered by AI

I am interested in enrolling as a test subject, who do I talk to?

"This study is looking for 1620 participants with bronchiectasis between the ages of 12 and 85. To be eligible, candidates must meet the following criteria: At least 2 episodes of pneumonia in the past 12 months that required a doctor's visit and antibiotic prescription; use condoms to avoid exposing pregnant women or those of childbearing potential to the medication; provide signed informed consent to participate in the study; have a history of non-cystic fibrosis bronchiectasis confirmed by chest CT scan (cough, chronic sputum production, recurrent respiratory infections); have had at least one pulmonary exacerbation in the prior 12 months"

Answered by AI

Could you tell me how many hospitals are conducting this research?

"To make participating more convenient for patients, this trial is being conducted at 100 sites. There are locations in West Valley City, Hammond and Syracuse along with other 97 locations."

Answered by AI

Is Brensocatib 25 mg effective for other medical conditions?

"Brensocatib 25 mg was first studied in 2020 as part of the MYS005 trials. Out of the 18292 total completed studies, 2 are ongoing with most taking place in West Valley City, Utah."

Answered by AI

What are the potential dangers associated with taking Brensocatib 25 mg?

"Brensocatib 25 mg has been studied in multiple Phase 3 trials, so there is a robust dataset documenting its efficacy and safety. Therefore, it received a score of 3."

Answered by AI

Do people over the age of 45 years qualify for this experiment?

"This trial is open to patients aged 12 to 85 years old. There are 84 similar studies for patients who are younger and 404 for senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
New York
Tennessee
Other
California
How old are they?
65+
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
USA027
USA019
USA086
Other
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

Yes berry open for trial asap. Antibiotic to inhale could not do it. Having this disease since I was a kid has totally impacted my quality of life, if I had a medicine that would help me breathe better and regain quality of life would be a blessing. I don't want to do the placebo, don't waste my time, I'm sick enough without false promises.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What is involved with the trial, Inhaler , etc?
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. USA086: < 48 hours
  2. USA109: < 48 hours
Recent research and studies
Clinical PharmacokineticsJournal
Pharmacokinetic/pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis
Chalmers, James D., Helen Usansky, Christopher M. Rubino, Ariel Teper, Carlos Fernandez, Jun Zou, and Kevin C. Mange. 2022. “Pharmacokinetic/pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis”. Clinical Pharmacokinetics. Springer Science and Business Media LLC. doi:10.1007/s40262-022-01147-w.
clinicaltrials.govStudy
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
2020. "A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04594369.
~408 spots leftby Apr 2025
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