| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01313624 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | PHASE3 | COMPLETED | 266 | — | — | Apr 1, 2011 | Jun 1, 2013 | Apr 16, 2014 | 60 | United States, Australia +1 |
| NCT01314716 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | PHASE3 | COMPLETED | 274 | — | — | Apr 1, 2011 | Jul 1, 2013 | Apr 16, 2014 | 85 | United States, Australia +8 |
| NCT00805025 | Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis | PHASE2 | COMPLETED | 89 | — | — | Dec 1, 2008 | Oct 1, 2009 | Mar 20, 2014 | 24 | United States |
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.
Test-retest reliability is a measure of the stability or reproducibility of a measure over a period of time during which status on the underlying construct has not changed, and is measured by the intraclass correlation of scores obtained at 2 time points within that period. Test-retest reliability of respiratory symptoms was calculated for response at Day -14 and Day 0. Reliability of the participants' QOL-B responses was assessed from an Intraclass Correlation Coefficient (ICC). A score of ≥ 0.70 would indicate strong reliability. The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Convergent validity was assessed at Day -14 by examining the correlations between relevant QOL-B domains and other indicators of health status: a bronchiectasis severity score based on high-resolution computerised tomography (HRCT) scan results, forced expiratory volume in 1 second (FEV1) percent predicted, 6-minute walk test (6MWT) results, and St. George's Respiratory Questionnaire (SGRQ) symptoms scores. Correlations with absolute values of 0.30 to 0.50 indicated moderate evidence of convergent validity.
| Arm | Type | Description |
|---|---|---|
| AZLI-AZLI | EXPERIMENTAL | 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. |
| Placebo-AZLI | PLACEBO_COMPARATOR | 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. |
| AZLI | EXPERIMENTAL | Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study. |
| Name | Type | Description |
|---|---|---|
| AZLI | DRUG | AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily |
| Placebo | DRUG | Placebo to match AZLI administered via nebulizer three times daily |
Inclusion Criteria: * Male/Female 18 years or older with non-CF bronchiectasis * Chronic sputum production on most days * Positive sputum culture for gram-negative organisms * Must have met lung function requirements Exclusion Criteria: * History of CF * Hospitalized within 14 days prior to joini...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD0292 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE2 | GSK3862995B |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Nebulized Ensifentrine ; |
| Baxter International Inc. | BAX | 1 | NA | Undisclosed |
| Inogen, Inc. | INGN | 1 | NA | Undisclosed |