AZISAST Study: AZIthromycin in Severe ASThma Study

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Azithromycin 250 mg; Drug: Placebo

• Registration Number: NCT00760838
• Lead Sponsor: University Hospital, Ghent

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Study Start: 2009-03
• Primary Completion: 2011-02
• Study Completion: 2011-09
• Results First Submitted: 2013-10-22
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-25
• Last Update Submitted: 2014-06-25
• Results First Posted: 2014-06-26
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

1. patients who have given written informed consent
2. males or females of any race
3. 18-75 years of age
4. with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
5. receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
6. patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months
7. patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years.

Exclusion Criteria

1. females who are pregnant or who are breastfeeding
2. patients with severe bronchiectasis
3. patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
4. patients with significant underlying medical conditions (e.g. infection, hematological disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
5. who are unable to perform spirometry or complete a patient diary or complete questionnaires
6. patients with known hypersensitivity to azithromycin or other macrolide antibiotics
7. patients who's heart rate corrected QT interval is prolonged
8. patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality
9. patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks)
10. anti-IgE treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azithromycin	Azithromycin 250 mg	Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards
placebo	Placebo	Placebo 1x/day during 5 days 3x/week afterwards

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Severe Asthma Exacerbations	from baseline to week 26	Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Using Rescue Medication From Baseline to Week 26	from baseline to week 26	proportion of participants using rescue medication is defined as the the number of participants who had to use rescue medication from baseline untill week 26, independent on the number of times the medication had to be used.; This measure was conducted by averaging the proportion of participants using rescue medication from each week between baseline and week 26.
Change in Forced Expiratory Volume in 1 Second	from baseline to week 26
Change in Total Score on Asthma Control Questionnaire (ACQ)	from baseline to week 26	A simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment.; ACQ has a multidimensional construct assessing symptoms (5 items--self-administred) and rescue inbronchodilator use (1 item-self-administered), and FEV1% (1 item) completed by clinic staff; Scaling of items: 7-point scale (0=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%); Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Change in Total Score on the Asthma-related Quality of Life (AQLQ)	from baseline to week 26	A disease-specific health-related quality of life instrument that taps both physical and emotional impact of disease; 32 items with 2-week recall: Symptoms (11 items), Activity Limitation (12 items, 5 of which are individualized), Emotional Function (5 items), and Environmental Exposure (4 items); 7-point Likert scale (7 = not impaired at all - 1 = severely impaired).; Scores range 1-7, with higher scores indicating better quality of life.
Peakflow Measurements	from baseline to week 26	change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second

Trial Locations

Locations (7)

AZ Sint-Jan Brugge; 🇧🇪 Brugge, Belgium

Onze Lieve Vrouw Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

AZ Heilig Hart Roeselare; 🇧🇪 Roeselare, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium