None listed
Conditions
Brief summary
This study is a new initiative to promote appropriate use of long-term macrolide antibiotics such as azithromycin, clarithromycin, roxithromycin and erythromycin in the management of respiratory diseases such as asthma, COPD and non-cystic fibrosis bronchiectasis. Although these drugs are effective, it is not clear for how long the treatment should be continued. Guidelines recommend a treatment duration of 6-12 months. They also recommend a drug break each year. In this study, we are investigating whether it is possible to stop these drugs permanently or at least temporarily after undergoing a certain period of treatment. We are looking for participants who are currently taking azithromycin, clarithromycin, roxithromycin or erythromycin for the treatment of asthma, COPD or bronchiectasis for at least 6 months. Participants will be randomised to one of the two study groups. Participants in both groups will stop the current macrolide during the Australian summer season as we anticipate that the summer season would be the best time to try medication withdrawal in respiratory diseases. After stopping the current macrolide, group 1 will start an equivalent macrolide which will be azithromycin, and group 2 will start an identical placebo. Participants will continue the study medication for a period of nine months with scheduled follow-ups at 3-, 6- and 9-months.
Interventions
This is a medication de-escalation study. The intervention is ceasing the current maintenance (long-term) macrolide antibiotic during the Australian summer season. To maintain blinding, the intervention arm participants will receive a placebo after stopping the current macrolide. The dose and frequency of the study medication will be independent of the dose and frequency of the current macrolide use. All participants randomised to this arm will receive 500mg placebo tablets (administered orally)
This is a medication de-escalation study. The intervention is ceasing the current maintenance (long-term) macrolide antibiotic during the Australian summer season. To maintain blinding, the intervention arm participants will receive a placebo after stopping the current macrolide. The dose and frequency of the study medication will be independent of the dose and frequency of the current macrolide use. All participants randomised to this arm will receive 500mg placebo tablets (administered orally) three times a week for nine months. The composition of placebo tablet includes microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate and sodium stearyl fumarate. The self-reported adherence will be assessed at each follow-up visits.
Sponsors
Hunter New England Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
At least 18 years of age; currently receiving maintenance macrolide therapy (azithromycin, clarithromycin, roxithromycin or erythromycin) for the management of obstructive airway disease (asthma, COPD or bronchiectasis) for a period of at least 6 months; able to provide verbal informed consent; have access to a telephone; and willing to complete baseline and follow-up telephone interviews.
Exclusion criteria
Pregnant women (self-reported); patients with cystic fibrosis; the use of a macrolide for other conditions (e.g, mycobacterium avium complex infection, MAC) and unable to speak and understand English.
Outcome results
None listed