The AZISAST Randomized Controlled Clinical Trial: Azithromycine as add-on therapy in Severe, Non-Eosinophilic Asthma - AZISAST

Phase 1

• Conditions: ncontrolled severe asthma

• Registration Number: EUCTR2008-004089-15-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-12
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Patients who have given written informed consent
2) Males or female patients,18-75 years of age
3) With the diagnosis of persistent asthma = 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
4) Receiving high dose ICS (=1000 µg Fluticasone, = 800 µg Budesonide) plus inhaled LABA for at least 6 months prior to screening
5) Patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations - requiring treatment with systemic (oral or IV) corticosteroids - and/or courses of antibiotics due to lower respiratory tract infections - within the previous 12 months
6) Patients must be never-smokers or ex-smokers with a smoking history of = 10 pack-years (and smoking cessation at least one year prior to study enrolment)
7) The FeNO level should not exceed the upper limit of the normal value (see table under section 7.4.3 with reference values)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Females who are pregnant or breastfeeding
2) Women of childbearing potential (WOCBP) should be using one or more of the following acceptable methods of contraception: surgical sterilisation, hormonal contraception and double-barrier methods. Reliable contraception should be maintained throughout the study and for 14 days after study drug discontinuation.
3) Patients with severe bronchiectasis (defined as bronchiectasis visible on plain chest x-ray)
4) Patients with active tuberculosis or non-tuberculoses mycobacterial infections (NTM)
5) Patients with significant underlying medical conditions (e.g. haematological disease, malignancy, neurologic, renal [creatinin clearance < 40 ml/min], hepatic [severe hepatic insufficiency, i.e. Child-Pugh grade C], coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
6) Who are unable to perform spirometry or complete a patient diary or complete questionnaires
7) Who have previously been randomized into this study
8) Patients with known hypersensitivity to azithromycin or other macrolide antibiotics
9) Patients who’s heart rate corrected QT interval (Bazett’s QTc: see below: 7.4.8) measured at visit 1 or 2 is prolonged : > 450 ms (males) or > 470 ms (females). Patients who fail the screening ECG should not be rescreened.
10) Patients treated with prohibited concomitant medications should not be included in the trial (see 6.3.5)
11) Patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality or a clinically significant condition which may interfere with the study conduct or patient safety and compliance
12) Patients with a lower respiratory tract infection requiring treatment with a course of antibiotics or severe asthma exacerbation during the run-in period should be randomized six weeks after recovery from the infection or exacerbation. Those patients do not need to perform the screening visit a second time.

Study & Design

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