Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

Browse trials for

• Bronchiectasis 368

Bronchiectasis

368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.

This study's enrollment of 266 is above the median of 60 across 233 interventional studies indexed under Bronchiectasis.

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Study arms

• Experimental
  AZLI-AZLI

  Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.

  Drug: AZLI

• Placebo comparator
  Placebo-AZLI

  Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.

  Drug: AZLI · Drug: Placebo

Interventions

• DrugAZLI

  AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily

• DrugPlacebo

  Placebo to match AZLI administered via nebulizer three times daily

Primary outcomes

1. Change in QOL-B Respiratory Symptoms Score at Day 28

   The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.

   Time frame: Baseline to Day 28

Secondary outcomes

1. Change in QOL-B Respiratory Symptoms Score at Day 84

   The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.

   Time frame: Baseline to Day 84

2. Time to Protocol-Defined Exacerbation (PDE)

   Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria. * Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough * Minor Criteria: fever (\> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased \> 10% from baseline; new or increased hemoptysis

   Time frame: Baseline to Day 112

Baseline characteristics

Publications

• Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18. PubMed 25154045 ↗