The medical condition that will be investigated is that of chronic productive cough (with or without a diagnosis of asthma but without a diagnosis of bronchiectasis, smoking related chronic bronchitis or obvious immunodeficiency)
Conditions
Interventions
Trade Name: AZITHROMYCIN 250MG CAPSULES
Product Name: Azithromycin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Azithromycin
CAS Number: 83905-01-5
Concentration unit: mg milligram(s)
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection criteria for patients with chronic productive cough: - Age 18 or above (no upper age limit) - Male or female - Non-smokers for 10 years and 3 months in duration - Use of effective contraception: Acceptable contraceptive methods include: established use of oral, injected or implanted hormonal methods; placement of an intrauterine device (IUD) or intrauterine system (IUS); condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide; true abstinence (when this is in line with the preferred and usual lifestyle of the participant); or vasectomised partner. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 42 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients with chronic productive cough: - History of obvious inhaled irritant exposure - Evidence of primary or secondary immunodeficiency. - Clinically important bronchiectasis on HRCT scan - Prolonged QT interval on baseline or 1 month ECG or significant cardiac pathology prior to commencing azithromycin - Pregnancy or intent to become pregnant during course of study - Contra-indication to bronchoscopy (British Thoracic Society Guidelines) - Abnormal LFT’s (greater than 2x upper limit of normal)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of a 3 months of azithromycin treatment on patients cough-related quality of life as measured by a standard questionnaire to determine the impact of cough on someones life (the Leicester Cough Questionnaire or LCQ) ;Secondary Objective: 1) To determine the effect of 3 months of azithromycin treatment on the colour and amount of sputum, the pattern of inflammatory cells in the sputum (sputum cell counts) and type of inflammation in the lung (exhaled nitric oxide level), any micro-organisms seen in the sputum (sputum microbiology) and lung function (FEV1). 2) To describe the appearance of cells from the airways of the lung (endobronchial biopsies) and the pattern of inflammation present in washings of the airways of the lung (bronchial washes) before azithromycin treatment in order to better understand the nature of these patients' condition ;Primary end point(s): - Effect of azithromycin treatment on Leicester Cough Questionnaire (LCQ) score ;Timepoint(s) of evaluation of this end point: 12 weeks of azithromycin treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Effect of 12 weeks of azithromycin on sputum colour and 24 hour sputum collection weight • Effect of 12 weeks of azithromycin treatment on sputum microbiology • Effect of 12 weeks of azithromycin on sputum cell counts and exhaled nitric oxide level • Effect of 12 weeks of azithromycin on FEV1 • Cytokine profile pattern of bronchial wash samples at baseline (pre-azithromycin) • Histological analysis of bronchial biopsy samples (pre-azithromycin) ;Timepoint(s) of evaluation of this end point: 12 weeks of azithomycin treatment | — |
Countries
United Kingdom
Outcome results
None listed