AZISAST Study: AZIthromycin in Severe ASThma Study

Asthma Clinical Trial

— AZISAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760838
• Other study ID #: 2008/445
• Secondary ID: IWT 070709
• Status: Completed
• Phase: Phase 4
• First received: September 25, 2008
• Last updated: June 25, 2014
• Start date: March 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: September 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Azithromycin 250 mg
Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
• Placebo
Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	ZNA Middelheim	Antwerpen
Belgium	AZ Sint-Jan Brugge	Brugge
Belgium	Ghent University Hospital	Ghent
Belgium	AZ Groeninge	Kortrijk
Belgium	Universitair Ziekenhuis Leuven	Leuven
Belgium	AZ Heilig Hart Roeselare	Roeselare

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Agentschap voor Innovatie door Wetenschap en Technologie

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Severe Asthma Exacerbations	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.	from baseline to week 26	No
Secondary	Proportion of Participants Using Rescue Medication 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.	from baseline to week 26	No
Secondary	Peakflow Measurements	change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second	from baseline to week 26	No
Secondary	Change in Forced Expiratory Volume in 1 Second		from baseline to week 26	No
Secondary	Change in Total Score on Asthma Control Questionnaire (ACQ)	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).	from baseline to week 26	No
Secondary	Change in Total Score on the Asthma-related Quality of Life (AQLQ)	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.	from baseline to week 26	No

External Links

•   Website of the Ghent University Hospital