Efficacy of Azithromycin in Treatment of Bronchiectasis
Overview
- Phase
- Phase 4
- Intervention
- Azithromycin
- Conditions
- Bronchiectasis
- Sponsor
- Penang Hospital, Malaysia
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- 24 Hour Sputum Volume
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Bronchiectasis is a chronic lung condition characterised primarily by dilatation of the airways. Only a small number of clinical studies have been conducted investigating the use of macrolides to treat non-cystic fibrosis bronchiectasis. The purpose of this study is to determine the efficacy of 12 weeks treatment with azithromycin in adult patients with non-cystic fibrosis bronchiectasis.
Detailed Description
Previous studies of various macrolides with small sample sizes have reported some benefit with the reduction of sputum volume in bronchiectasis patients. However, macrolide therapy could not yet be confidently used to treat bronchiectasis, given the diffuse nature of these findings. These studies have had a wide range of hypotheses, and have not necessarily focused on the anti-inflammatory effects of macrolides. Furthermore, these studies are few in number, and not all have been placebo-controlled or double-blinded. This, combined with the small sample sizes used, limits the reliability of these results. This study aims to expand on these limited published findings by investigating a larger sample population with different endpoints. Sputum volume and quality of life have been selected as important variables to aid in assessing efficacy. This study aims to be independent of previous studies in a number of ways. This is the only study of bronchiectasis patients to formally investigate quality of life after treatment with a macrolide, and the potential carryover effect of azithromycin therapy. This study will also expand on the findings of previous studies of macrolides in bronchiectasis by incorporating a larger sample size into the trial.
Investigators
ALBERT IRUTHIARAJ L. ANTHONY
DR
Ministry of Health, Malaysia
Eligibility Criteria
Inclusion Criteria
- •Have provided written informed consent to participate in the study in accordance with the local ethics committee regulations
- •Have a confirmed diagnosis of bronchiectasis (by HRCT) Aged 18 years or over Have chronic sputum production, defined as a greater than 45 mililitres volume produced in the 1 week prior to study entry.
- •Be able to perform reproducible spirometry
- •Be in a relatively stable disease state in the 6 weeks prior to entry, as defined by the absence of the following: respiratory exacerbations requiring hospitalisation, change in cough and/or sputum production, new or increased hemoptysis, more than 10% weight loss, use of additional antibiotic courses
Exclusion Criteria
- •Subjects will be excluded if one or more of the following criteria occur. The subject: Is an investigator, or an immediate family member of an investigator
- •Has a confirmed diagnosis of cystic fibrosis, as evidenced by genetic analysis or a sweat test result more than 60mmol/L
- •Has a primary immunodeficiency Is a pregnant or lactating female Has had a respiratory exacerbation requiring hospitalisation or additional course of antibiotics in the 6 weeks prior to study entry
- •Has been prescribed or used oral steroids on any occasion for the 3 months prior to study entry.
- •Has been using mucolytic agents on any occasion for the 2 months prior to study entry Has active tuberculosis
- •Has an active malignancy, including melanoma (other skin carcinomas excluded)
- •Has a history of significant liver disease or insufficiency Has a significant history of drug abuse (including alcohol abuse) or mental illness Has a known intolerance or allergy to macrolides
- •Has been participating in another interventional drug study in the 3 months prior to enrolment into this study
Arms & Interventions
Azithromycin and Placebo for Azithromycin
Patients randomised to the treatment arm are to receive 1000 mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once weekly for another 12 weeks
Intervention: Azithromycin
Placebo for Azithromycin
In Part One of the study participants will be randomised to receive 12 weeks of either placebo or azithromycin in a 1:1 ratio in a double-blinded fashion. After 12 weeks, in Part Two of the study, all participants will receive placebo in a double-blinded fashion for an additional 12 weeks.
Intervention: Placebo for Azithromycin
Outcomes
Primary Outcomes
24 Hour Sputum Volume
Time Frame: Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)
Each participant must be instructed and enabled to collect 24 hour sputum volumes over the 24 hours prior to visits 3, 6 and 8, inclusive. As this is the primary endpoint of the study, it is critical that 24 hour sputum volumes are measured and recorded accurately, observing the following protocol: The subject should be given a sterile jar to collect the sputum, which has been weighed previously for convenience. Each jar will be labelled with subject name, start and finish time/date The collection should commence on rising in the morning and complete 24 hours later. Ensure that the sputum sample has minimal saliva in the collection Instruct subject to collect all sputum produced spontaneously or after coughing over a single daytime 24 hour period. The sample should come from the lungs and should not be salivary. Encourage subject not to swallow sputum, but to collect. Each 24 hour collection period should be as similar as possible in terms of physiotherapy and exercise regimens
Secondary Outcomes
- Health Status: St George's Respiratory Questionnaire Score(Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
- Spirometric Values: Forced Vital Capacity (FVC)(Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))
- Spirometry Value; Forced Expiratory Volume at 1 Second (FEV1)(Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24))