Phase II, randomized, double arm, multi-center study evaluating the efficacy and safety of azithromycin for the long term prophylactic treatment of COPD in primary antibody deficiency patients with clinical and spirometrically confirmed COPD suffering from repeated acute exacerbations

• Conditions: primary immunodefciency patients with COPD and frequent exacerbations; MedDRA version: 14.1Level: LLTClassification code 10029978Term: Obstructive chronic bronchitis with acute exacerbationSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10013289Term: Disorders involving the immune mechanismSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 14.1Level: LLTClassification code 10003554Term: Asthma aggravatedSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-004351-39-IT
• Lead Sponsor: AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-13
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•diagnosis of X-linked Agammaglobulinemia or Common Variable Immunodeficiency •male or female aged 12 to 74 years •clinical and spirometrically confirmed COPD •written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 38
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• known allergic reaction to azithromycin • patients taking drugs that could adversely interact with macrolides • lymphoproliferative disease • Creatinine concentration >1.5 times the UNL • ASAT or ALAT concentration >2.5 times the UNL • HIV infection, acute hepatitis or clinically active chronic hepatitis • Pregnancy or breast feeding females planning to become pregnant during the course of the study • Any condition that is likely to interfere with the evaluation of the study drug or satisfactory conduct of the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified