A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects with non-CF Bronchiectasis and Gram-Negative Endobronchial Infectio

Phase 3

Completed

• Conditions: bronchiectasis; permanently dilated airways; 10006436

• Registration Number: NL-OMON35895
• Lead Sponsor: Gilead Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- Male/Female >= 18 years old
- Bronchiectasis confirmed by documented computed tomography (CT) scan within 5 years prior to Visit 1, or by prior approval of the Medical Monitor without intervening lung resection
- Reported chronic sputum production on most days during the 4 weeks prior to Visit 1
- Positive sputum culture for target gram-negative organism(s) at Visit 1
- Documented history of positive sputum culture (or bronchoscopic culture) for a target gram-negative organism OR documented history of treatment with antibiotics with gram-negative coverage for an exacerbation of bronchiectasis within 5 years prior to Visit 1
- Chest X-Ray (CXR) obtained and interpreted at Visit 1 or between Visits 1 and 2, without significant acute findings (e.g., no new infiltrate) With prior approval of the Medical Monitor, a CXR obtained within 10 days prior to Visit 1 may be acceptable for study entery.
- Forced expiratory volume in one second (FEV1) >=20% predicted approximately 15 minutes post-bronchodilator at Visit 1

Exclusion Criteria

- Hospitalization within 14 days prior to Visit 1
- Reported episode of hemoptysis > 30 mL (~2 tablespoons) within 28 days prior to Visit 1, on the day of Visit 1, and from Visit 1 through Visit 2
- Antibiotics to treat respiratory symptoms (excluding chronic, stable treatment with a macrolide) within 14 days prior to Visit 1, on the day of Visit 1, and from Visit 1 through Visit 2
- Change in bronchodilator, inhaled corticosteroid, macrolide, or bronchial hygiene therapies within 28 days prior to visit 1 and through study completion.
- Change in systemic corticosteroid therapy within 28 days prior to Visit 1 and from Visit 2. After Visit 2, systemic corticosteroid therapy (maximum of 14 days per course) will be allowed to treat worsening respiratory signs and/or symptoms.
- Previous treatment with or exposure to Cayston® (AZLI)
- Serious adverse event between Visits 1 and 2
- History of cystic fibrosis (CF)
- Current treatment for nontuberculous mycobacteria (NTM) infection
- Active mycobacterium tuberculosis (MTB) infection within one year prior to Visit 1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in the Respiratory Symptoms score on the<br /><br>QOL-B from baseline to the end of placebo-controlled Course 1 (i.e., change<br /><br>from Day 0 [Visit 2] to Day 28 [Visit 4]).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are:<br /><br>- Change in the Physical Functioning score on the QOL-B from baseline to the<br /><br>end of placebo-controlled Course 1 (i.e., change from Day 0 [Visit 2] to Day 28<br /><br>[Visit 4])<br /><br>- Change in the Respiratory Symptoms score on the QOL-B at the end of<br /><br>placebo-controlled Course 2 (Day 84 [Visit 6]) compared to baseline (Day 0<br /><br>[Visit 2])<br /><br>- Change in the Physical Functioning score on the QOL-B at the end of<br /><br>placebo-controlled Course 2 compared to baseline<br /><br>- Time to Protocol-Defined Exacerbation (PDE) prior to open-label AZLI<br /><br>treatment</p><br>