What side effects are associated with this type of intervention?

Common treatments for bronchiectasis include antibiotics, bronchodilators, and mucolytics. Antibiotics can cause side effects such as gastrointestinal upset, allergic reactions, and antibiotic resistance. Bronchodilators, including beta agonists, may lead to tremors, palpitations, and headaches. Mucolytics can cause nausea and gastrointestinal discomfort. For treatments similar to Brensocatib, a DPP1 inhibitor, side effects observed in clinical trials include gastrointestinal issues, infections, and potential liver enzyme elevations. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically targeting DPP1 inhibitors like Brensocatib for Bronchiectasis. The management of Bronchiectasis typically involves antibiotics to treat infections, bronchodilators to open airways, and mucolytics to thin mucus. Commonly used antibiotics include azithromycin and inhaled tobramycin, while bronchodilators like albuterol and mucolytics such as hypertonic saline are also employed. The focus remains on managing symptoms and preventing exacerbations rather than targeting the underlying disease mechanisms as Brensocatib aims to do.

What other types of research exist?

Promising novel alternatives to Brensocatib for bronchiectasis patients include inhaled antibiotics like liposomal amikacin, which targets chronic lung infections, and anti-inflammatory agents such as macrolides (e.g., azithromycin) that have shown efficacy in reducing exacerbations. Additionally, CFTR modulators, though primarily for cystic fibrosis, are being explored for their potential benefits in non-cystic fibrosis bronchiectasis.

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Anti-inflammatory

Brensocatib for Bronchiectasis (ASPEN Trial)

Q: What is the mechanism of action of this treatment?

Bronchiectasis treatments aim to reduce inflammation, manage infections, and improve mucus clearance. Brensocatib, a DPP1 inhibitor, works by reducing the activation of neutrophil serine proteases, which are enzymes that contribute to inflammation and tissue damage in the lungs. By inhibiting these enzymes, Brensocatib helps to decrease inflammation and prevent further lung damage. Other common treatments include antibiotics to manage infections, mucolytics to thin mucus and facilitate its clearance, and bronchodilators to open the airways. These treatments are crucial for Bronchiectasis patients as they help to control symptoms, reduce exacerbations, and improve overall lung function and quality of life.

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.

Must not have

A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator

Bronchiectasis due to cystic fibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called brensocatib in two doses (10 mg and 25 mg) to see if it can reduce lung flare-ups. The study focuses on patients who often have worsening lung symptoms. The goal is to see if brensocatib can help these patients have fewer severe lung problems.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with COPD or asthma.

Select...

My bronchiectasis is caused by cystic fibrosis.

Select...

I have a weak immune system or history of serious infections.

Select...

I have been diagnosed with HIV.

Select...

I am currently being treated for a lung infection or TB.

Select...

I currently have symptoms of COVID-19.

Select...

I am not on any medications that are not allowed in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2019 Phase 2 trial • 256 Patients • NCT03218917

13%

Cough

13%

Headache

10%

Sputum increased

Dyspnoea

Fatigue

Periodontal disease

Sinusitis

Upper respiratory tract infection

Infective exacerbation of bronchiectasis

Pneumonia

Diarrhoea

Haemoptysis

Hypertension

Haemorrhoids

Arthralgia

Respiratory failure

Ventricular extrasystoles

Intestinal obstruction

Epistaxis

100%

80%

60%

40%

20%

Study treatment Arm

Brensocatib 25 mg

Placebo

Brensocatib 10 mg

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bronchiectasis treatments aim to reduce inflammation, manage infections, and improve mucus clearance. Brensocatib, a DPP1 inhibitor, works by reducing the activation of neutrophil serine proteases, which are enzymes that contribute to inflammation and tissue damage in the lungs. By inhibiting these enzymes, Brensocatib helps to decrease inflammation and prevent further lung damage. Other common treatments include antibiotics to manage infections, mucolytics to thin mucus and facilitate its clearance, and bronchodilators to open the airways. These treatments are crucial for Bronchiectasis patients as they help to control symptoms, reduce exacerbations, and improve overall lung function and quality of life.