Phase 4 Completed N=119 Randomized Quadruple-blind Treatment

Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)

Cystic fibrosis

Source: ClinicalTrials.gov NCT02677701 ↗

Enrolled (actual)

119

Serious AEs

6.1%

Results posted

Mar 2021

Primary outcomePrimary: Relative Change in Lung Function — 1.69; -1.95 percent change — p=0.0846

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.