Phase 4
N=119
Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02677701 ↗Enrolled (actual)
119
Serious AEs
6.1%
Results posted
Mar 2021
Primary outcome: Primary: Relative Change in Lung Function — 1.69; -1.95 percent change — p=0.0846
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- azithromycin (Drug); placebo (for azithromycin) (Drug); inhaled tobramycin (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change in Lung Function |
0.44; -0.91 | 0.51 |
| SECONDARY Relative Change in Lung Function |
0.44; -0.91 | 0.51 |
| SECONDARY Change in Cystic Fibrosis Respiratory Symptom Diary - Chronic Respiratory Infection Symptom Score (CFRSD-CRISS) |
-2.3; 0.6 | 0.17 |
| SECONDARY Change in Cystic Fibrosis Questionnaire - Revised Respiratory Symptom Score (CFQ-R RSS) |
1.0; -0.5 | 0.56 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 12 years old or older
- documented diagnosis of cystic fibrosis
- written informed consent (and assent when applicable)
- at least two respiratory cultures growing P. aeruginosa within the last 12 months
- FEV1% predicted between 25-100%
- use of at least two cycles of inhaled tobramycin within the last 24 weeks
- Off TISP and other inhaled anti-pseudomonal antibiotics for at least 2 weeks at Visit 1 and remain off of any inhaled antibiotics for an additional 2 weeks before starting inhaled tobramycin
- most recent liver function test results less than 4 times the upper limit of normal, obtained within the last 12 months
- prior or current use of azithromycin for at least four consecutive weeks
- stable clinical status and therapeutic regimen
Exclusion Criteria
- weight 480 msec for males and >486 msec for females
- any other condition that, in the opinion of the site investigator, would compromise the safety of the subject or quality of the data
Data sourced from ClinicalTrials.gov (NCT02677701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.