AZISAST Study: AZIthromycin in Severe ASThma Study

Condition(s) targeted: Asthma

Intervention: Azithromycin 250 mg (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Ghent

Official(s) and/or principal investigator(s):
Guy Brusselle, MD, PhD, Principal Investigator, Affiliation: Ghent University Hospital

Overall contact:
Hermine Middendorp, Email: Hermine.middendorp@uzgent.be

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.

Official title: The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Rate of severe asthma exacerbations

Secondary outcome:

Asthma symptoms

Rescue medication use

Peakflow measurements

Pre-and postbronchodilatation spirometry

Exhaled NO (FeNO)

Asthma control (ACQ)

Asthma-related quality of life (AQLQ)

Number of severe asthma exacerbations

Time to first severe asthma exacerbation

Total dose of systemic corticosteroid use

Total number of acute upper and lower respiratory tract infections treated with antibiotics (other than macrolides)

Health-economic evaluation (use of health care resources and EQ-5D)

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Hermine Middendorp, Email: Hermine.middendorp@uzgent.be

Ghent University Hospital, Ghent 9000, Belgium; Recruiting
Guy Brusselle, MD, PhD, Principal Investigator

Universitair Ziekenhuis Leuven, Leuven 3000, Belgium; Recruiting
Geert Verleden, MD, PhD, Principal Investigator

AZ Sint-Jan Brugge, Brugge 8000, Belgium; Recruiting
Veerle Ringoet, MD, Principal Investigator

AZ Groeninge, Kortrijk 8500, Belgium; Recruiting
René Deman, MD, Principal Investigator

ZNA Middelheim, Antwerpen 2020, Belgium; Recruiting
Hans Slabbynck, MD, Principal Investigator

Onze Lieve Vrouw Ziekenhuis Aalst, Aalst 9300, Belgium; Recruiting
Paul Jordens, MD, Principal Investigator

Website of the Ghent University Hospital

Starting date: March 2009
Ending date: December 2012
Last updated: April 14, 2009