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AZISAST Study: AZIthromycin in Severe ASThma Study (AZISAST)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Azithromycin 250 mg
Placebo
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Inadequately controlled severe asthma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Onze Lieve Vrouw Ziekenhuis Aalst
  • ZNA Middelheim
  • AZ Sint-Jan Brugge
  • Ghent University Hospital
  • AZ Groeninge
  • Universitair Ziekenhuis Leuven
  • AZ Heilig Hart Roeselare

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azithromycin

placebo

Arm Description

Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards

Placebo 1x/day during 5 days 3x/week afterwards

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Peakflow Measurements
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
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).
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.

Full Information

First Posted
September 25, 2008
Last Updated
June 25, 2014
Sponsor
University Hospital, Ghent
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie
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1. Study Identification

Unique Protocol Identification Number
NCT00760838
Brief Title
AZISAST Study: AZIthromycin in Severe ASThma Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Agentschap voor Innovatie door Wetenschap en Technologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Inadequately controlled severe asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin
Arm Type
Experimental
Arm Description
Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1x/day during 5 days 3x/week afterwards
Intervention Type
Drug
Intervention Name(s)
Azithromycin 250 mg
Intervention Description
Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
Primary Outcome Measure Information:
Title
Proportion of Participants With Severe Asthma Exacerbations
Description
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.
Time Frame
from baseline to week 26
Secondary Outcome Measure Information:
Title
Proportion of Participants Using Rescue Medication From Baseline to Week 26
Description
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.
Time Frame
from baseline to week 26
Title
Peakflow Measurements
Description
change in peak expiratory volume peak expiratory volume is measured as a maximal expiration for 1 second
Time Frame
from baseline to week 26
Title
Change in Forced Expiratory Volume in 1 Second
Time Frame
from baseline to week 26
Title
Change in Total Score on Asthma Control Questionnaire (ACQ)
Description
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).
Time Frame
from baseline to week 26
Title
Change in Total Score on the Asthma-related Quality of Life (AQLQ)
Description
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.
Time Frame
from baseline to week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who have given written informed consent males or females of any race 18-75 years of age with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years. Exclusion Criteria: females who are pregnant or who are breastfeeding patients with severe bronchiectasis patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM) 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 who are unable to perform spirometry or complete a patient diary or complete questionnaires patients with known hypersensitivity to azithromycin or other macrolide antibiotics patients who's heart rate corrected QT interval is prolonged patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks) anti-IgE treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Brusselle, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouw Ziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
AZ Sint-Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Ghent University Hospital
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Heilig Hart Roeselare
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
34807989
Citation
Undela K, Goldsmith L, Kew KM, Ferrara G. Macrolides versus placebo for chronic asthma. Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD002997. doi: 10.1002/14651858.CD002997.pub5.
Results Reference
derived
PubMed Identifier
23291349
Citation
Brusselle GG, Vanderstichele C, Jordens P, Deman R, Slabbynck H, Ringoet V, Verleden G, Demedts IK, Verhamme K, Delporte A, Demeyere B, Claeys G, Boelens J, Padalko E, Verschakelen J, Van Maele G, Deschepper E, Joos GF. Azithromycin for prevention of exacerbations in severe asthma (AZISAST): a multicentre randomised double-blind placebo-controlled trial. Thorax. 2013 Apr;68(4):322-9. doi: 10.1136/thoraxjnl-2012-202698. Epub 2013 Jan 3.
Results Reference
derived
Links:
URL
http://www.uzgent.be
Description
Website of the Ghent University Hospital

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AZISAST Study: AZIthromycin in Severe ASThma Study

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