A randomised, prospective double-blind trial of long-term daily versus weekly azithromycin in cystic fibrosis

A randomised, prospective double-blind trial of long-term daily versus weekly azithromycin to determine the effect of dose on disease parameters in cystic fibrosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000162617

Enrollment

184

Registered

2005-08-16

Start date

2002-05-21

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

A 6-month randomised double-blind trial of 250mg daily versus 1200mg weekly azithromycin in cystic fibrosis

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

Consenting children and adults (age >/6 years; weight >/ 25kg) with Clinically stable (at least 2 weeks since last acute IV/oral antibiotic therapy; FEV1 within 10% of average for last 6 months).

Exclusion criteria

Inability to provide written informed consent. Patients with a known allergy to macrolides. Patients taking terfenadine (Teldane), zidovudine (AZT), digoxin (Lanoxin), cyclosporin (Neroal). Patients taking any macrolide antibiotics in the 8 weeks prior to enrolment. Atypical mycobacteria infection of clinical significance. Commencement of anti-inflammatory therapy or mucolytic therapy in the month prior to enrolment, or during the duration of the study. Patient or their partner pregnant, or planning to become pregnant in the next 6 months. Patients with known liver impairment: portal hypertension or proven liver cirrhosis.

Outcome results