primary immunodefciency patients with COPD and frequent exacerbations MedDRA version: 14.1 Level: LLT Classification code 10029978 Term: Obstructive chronic bronchitis with acute exacerbation System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10013289 Term: Disorders involving the immune mechanism System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1 Level: LLT Classification code 10003554 Term: Asthma aggravate
Conditions
Interventions
Product Name: Azytromicyn
Product Code: NA
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: FARM8MXYFL
Other descriptive name: Azithromycin
Concentration unit: mg milligram(s)
Concentrati
Sponsors
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: in the arm of patients under azythomycin prophylaxis we expect a superiority on the following end-point: - decrease annual episodes of acute COPD exacerbations defined as: - dyspnoea;- increased cough; -increased sputum volume and purulence;Secondary Objective: in the arm of patients under azythomycin prophylaxis in respect to the arm of patients under placebo we expect a superiority on the following end-points: - decrease number of additional doses of antibiotics required for treatment of the exacerbations (other than the prophylactic antibiotics given as study medicine) - decrease in the number of patients not having an exacerbation during the course of the study - decrease in the recurrence time to next exacerbation - decrease of the duration of exacerbations (days of disability per exacerbation) - improvement of the Health Related Quality of Life measures - increase of FEV1 - reduction in the number of days of disability variously defined as days in bed, days off work or days where the subject is unable to undertake normal activities Safety analy sis: -calculate the number of adverse events;Primary end point(s): Efficacy: Decrease annual episodes of acute COPD exacerbations defined as: - dyspnoea;- increased cough; -increased sputum volume and purulence. Safety: Adverse events (total, severe, fatal);Timepoint(s) of evaluation of this end point: 30 visits have been scheduled: 1 visit each month for the treatment period (24 months); 1 visit each month for the treatment period (6 months). During each visit will be performed the physical examination and will be collected informations concerning AE/SAE and the drug compliance. the patient will compile diaries and the SF36 questionnaire at visits 1, 12, 24 and 26. Sputum sample will be collected on each visit. Every 4 months will be performed the routine blood testing, urinalysis and FEV1 evaluation, | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Decrease number of additional doses of antibiotics required for treatment of the exacerbations (other than the prophylactic antibiotics given as study medicine) • Decrease in the number of patients not having an exacerbation during the course of the study -Decrease in the recurrence time to next exacerbation • Decrease of the duration of exacerbations (days of disability per exacerbation) • Improvement of the Health related quality of life measures • Increase of FEV1 • Reduction in the number of days of disability variously defined as days in bed, days off work or days where the subject is unable to undertake normal activities;Timepoint(s) of evaluation of this end point: 30 visits have been scheduled: 1 visit each month for the treatment period (24 months); 1 visit each month for the treatment period (6 months). During each visit will be performed the physical examination and will be collected informations concerning AE/SAE and the drug compliance. the patient will compile diaries and the SF36 questionnaire at visits 1, 12, 24 and 26. Sputum sample will be collected on each visit. Every 4 months will be performed the routine blood testing, urinalysis and FEV1 evaluation. | — |
Countries
Italy
Contacts
Public ContactUOD Reference Centre for Immunodefi
Azienda Policlinico Umberto I
Outcome results
None listed