Last reviewed · How we verify
Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)
Phase 4 trial testing azithromycin in Cystic Fibrosis in 119 participants. Completed in 13 February 2020.
| Lead sponsor | Seattle Children's Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 119 |
| Start date | 21 October 2016 |
| Primary completion | 13 February 2020 |
| Estimated completion | 13 February 2020 |
| Sites | 39 locations across United States |
Seattle Children's Hospital
12 and older, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Relative change in FEV1 volume (L) from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6
| Group | Value | 95% CI |
|---|---|---|
| Azithromycin | 1.69 | ± 10.39 |
| Placebo | -1.95 | ± 10.73 |
Relative change in FEV1 (L) from the beginning of the 4-week period with inhaled tobramycin at week 2 to the end of the 4-week period with inhaled tobramycin at week 6
| Group | Value | 95% CI |
|---|---|---|
| Azithromycin | 0.44 | ± 8.86 |
| Placebo | -0.91 | ± 11.41 |
Absolute change in CFRSD-CRISS from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6. The Cystic Fibrosis Respiratory Symptoms Diary asks a participant to state the extent of 8 respiratory symptoms: difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest, and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present "a great deal" or "extremely." A summed score (rangi
| Group | Value | 95% CI |
|---|---|---|
| Azithromycin | -2.3 | ± 11.4 |
| Placebo | 0.6 | ± 9.8 |
Absolute change in the CFQ-R RSS from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6. Age appropriate versions of Cystic Fibrosis Questionnaire - Revised ask a participant from 4 to 6 questions related to respiratory symptoms. The Respiratory Domain Scaled Score is calculated as follows: 100\*\[sum of {responses-1}\] / \[{number of responses}\*3\] only if \[number of responses\] ≥ \[number of possible responses\]/2; otherwise the score is set to missing. The scaled score ranges from 0 to 100 and higher scores indicate improvement of symptoms.
| Group | Value | 95% CI |
|---|---|---|
| Azithromycin | 1.0 | ± 14.0 |
| Placebo | -0.5 | ± 12.5 |
Absolute change in log10 transformed quantitative Pseudomonas aeruginosa (Pa) bacterial density as measured by colony forming units (CFUs) per mL of sputum from enrollment at week 0 to the end of the 4-week period with inhaled tobramycin at week 6. Culture results below the lower limit of detection of 1x10\^2 were set to 1/2 of that LLD prior to log transformation.
| Group | Value | 95% CI |
|---|---|---|
| Azithromycin | 0.3 | ± 1.7 |
| Placebo | -0.5 | ± 1.2 |
Time frame: 6 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Azithromycin | Placebo |
|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Sinusitis | Infections and infestations | — | — |
| Forced expiratory volume decreased | Investigations | — | — |
| Weight decreased | Investigations | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Testicular torsion | Reproductive system and breast disorders | — | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | — | — |
| Night sweats | Skin and subcutaneous tissue disorders | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Reaction | System | Azithromycin | Placebo |
|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Sputum increased | Respiratory, thoracic and mediastinal disorders | — | — |
| Wheezing | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Cough, Dyspnoea, Constipation, Nausea, Vomiting, Chills, Pyrexia, Sinusitis.
Data from ClinicalTrials.gov NCT02677701 adverse events section.
This is a study to examine the effect of combining chronic oral azithromycin with inhaled tobramycin in adolescent and adult subjects with cystic fibrosis who are chronically infected with P. aeruginosa.
8 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02677701.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing