Efficacy of Azithromycin in Treatment of Bronchiectasis

NCT02107274 | Completed Phase 4 Results DMC

• 1 other identifier: NMRR-09-1075-5016
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Azithromycin; Bronchiectasis; Macrolide; Inflammation; Pulmonary

Outcome Measures

Primary Outcomes (1)

• 24 Hour Sputum Volume

  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

  Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)

Secondary Outcomes (3)

• Health Status: St George's Respiratory Questionnaire Score

  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)

• Spirometric Values: Forced Vital Capacity (FVC)

  Visit 3 (Baseline); Visit 6 (Week 12); Visit 8 (Week 24)

Study Arms (2)

Azithromycin and Placebo for Azithromycin

ACTIVE COMPARATOR

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

Drug: Azithromycin

Placebo for Azithromycin

PLACEBO COMPARATOR

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.

Drug: Placebo for Azithromycin

Interventions

Azithromycin DRUG

Azithromycin (C38H72N2O12 MW 749) is a 15-membered azalide, a subclass of macrolide antibiotics

Also known as: Zithromax 250 mg tablet

Azithromycin and Placebo for Azithromycin

Placebo for Azithromycin DRUG

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.

Placebo for Azithromycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penang Hospital, Malaysia: lead

Study Sites (1)

Respiratory Unit, Taiping Hospital

Taiping, Perak, 34000, Malaysia

Location

Related Publications (4)

• Cymbala AA, Edmonds LC, Bauer MA, Jederlinic PJ, May JJ, Victory JM, Amsden GW. The disease-modifying effects of twice-weekly oral azithromycin in patients with bronchiectasis. Treat Respir Med. 2005;4(2):117-22. doi: 10.2165/00151829-200504020-00005.

  PMID: 15813663 BACKGROUND

• Anwar GA, Bourke SC, Afolabi G, Middleton P, Ward C, Rutherford RM. Effects of long-term low-dose azithromycin in patients with non-CF bronchiectasis. Respir Med. 2008 Oct;102(10):1494-6. doi: 10.1016/j.rmed.2008.06.005. Epub 2008 Jul 23.

  PMID: 18653323 BACKGROUND

• Davies G, Wilson R. Prophylactic antibiotic treatment of bronchiectasis with azithromycin. Thorax. 2004 Jun;59(6):540-1. No abstract available.

  PMID: 15170047 BACKGROUND

• Lourdesamy Anthony AI, Muthukumaru U. Efficacy of azithromycin in the treatment of bronchiectasis. Respirology. 2014 Nov;19(8):1178-82. doi: 10.1111/resp.12375. Epub 2014 Sep 2.

  PMID: 25183304 DERIVED

MeSH Terms

Conditions

Bronchiectasis; Inflammation

Interventions

Azithromycin; Tablets

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Albert Iruthiaraj L. Anthony
• Organization: Ministry of Health of Malaysia

albert5409@yahoo.com

+60174633410

Study Officials

• ALBERT IRUTHIARAJ ANTHONY, MBBS

  Penang Hospital, Malaysia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: April 3, 2014
• First Posted: April 8, 2014
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 18, 2014
• Results First Posted: July 9, 2014

Record last verified: 2014-07

Locations

MY (1)