ActivePhase 4ACTRN12605000162617
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
Sponsor
Associate Professor Joseph McCormack, University of Queensland, Department of Medicine, Mater Hospital, South Brisbane, 4101
Enrollment
184 participants
Start Date
May 21, 2002
Study Type
Interventional
Conditions
Eligibility
Sex: Both males and femalesMin Age: 6 Yearss
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
A 6-month randomised double-blind trial of 250mg daily versus 1200mg weekly azithromycin in cystic fibrosis
A 6-month randomised double-blind trial of 250mg daily versus 1200mg weekly azithromycin in cystic fibrosis
Locations(1)
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ACTRN12605000162617
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