AZISAST Study: AZIthromycin in Severe ASThma Study
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Proportion of Participants With Severe Asthma Exacerbations [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]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.
- Proportion of Participants Using Rescue Medication From Baseline to Week 26 [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]
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.
- Peakflow Measurements [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second
- Change in Forced Expiratory Volume in 1 Second [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]
- Change in Total Score on Asthma Control Questionnaire (ACQ) [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]
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) [ Time Frame: from baseline to week 26 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||March 2009|
|Study Completion Date:||September 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Azithromycin 250 mg
1x/day during 5 days 3x/week afterwards
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 Comparator: placebo
1x/day during 5 days 3x/week afterwards
Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760838
|Onze Lieve Vrouw Ziekenhuis Aalst|
|Aalst, Belgium, 9300|
|Antwerpen, Belgium, 2020|
|AZ Sint-Jan Brugge|
|Brugge, Belgium, 8000|
|Ghent University Hospital|
|Ghent, Belgium, 9000|
|Kortrijk, Belgium, 8500|
|Universitair Ziekenhuis Leuven|
|Leuven, Belgium, 3000|
|AZ Heilig Hart Roeselare|
|Roeselare, Belgium, 8800|
|Principal Investigator:||Guy Brusselle, MD, PhD||University Hospital, Ghent|