Study of Aztreonam for Inhalation Versus Placebo in Patients with Bronchiectasis and Specific Bacteria in the Airways

Phase 1

• Conditions: on-CF bronchiectasis and gram-negative endobronchial infection; MedDRA version: 14.1Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1Level: PTClassification code 10070295Term: Infective exacerbation of bronchiectasisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-023959-28-GB
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-09
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

• Male/Female not less than 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 entry
• Forced expiratory volume in one second (FEV1) not less than 20% predicted approximately 15 minutes post-bronchodilator at Visit 1

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 232
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

• Hospitalization within 14 days prior to Visit 1
• Reported episode of hemoptysis greater than 30 mL (~2 tablespoons) within 14 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 1 through 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is designed to assess the safety and efficacy of aztreonam for inhalation solution/aztreonam 75 mg powder and solvent for nebuliser solution (AZLI) in subjects with non-CF bronchiectasis and gram negative endobronchial infection.;Secondary Objective: Not Applicable.;Primary end point(s): The primary endpoint is the change in the Respiratory Symptoms score on the QOL-B from baseline to the end of placebo-controlled Course 1 (i.e., change from Day 0 [Visit 2] to Day 28 [Visit 4]).;Timepoint(s) of evaluation of this end point: Change from Day 0 [Visit 2] to Day 28 [Visit 4]

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change in the Respiratory Symptoms score on the QOL-B at the end of placebo-controlled Course 2 (Day 84 [Visit 6]) compared to baseline (Day 0 [Visit 2])<br>• Time to Protocol-Defined Exacerbation (PDE) prior to open label AZLI treatment<br>;Timepoint(s) of evaluation of this end point: • Change from Day 0 [Visit 2] to Day 84 [Visit 6]<br>• Entire time from Day 0 [Visit 2] to Day 112 [Visit 7]