AZISAST Study: AZIthromycin in Severe ASThma Study

This study has been completed.
Sponsor:
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00760838
First received: September 25, 2008
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Azithromycin 250 mg
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 109
Study Start Date: March 2009
Study Completion Date: September 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azithromycin

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

Placebo

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760838

Locations
Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, 9300
ZNA Middelheim
Antwerpen, Belgium, 2020
AZ Sint-Jan Brugge
Brugge, Belgium, 8000
Ghent University Hospital
Ghent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
AZ Heilig Hart Roeselare
Roeselare, Belgium, 8800
Sponsors and Collaborators
University Hospital, Ghent
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
Principal Investigator: Guy Brusselle, MD, PhD Ghent University Hospital
  More Information

Additional Information:
No publications provided by University Hospital, Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00760838     History of Changes
Other Study ID Numbers: 2008/445, IWT 070709
Study First Received: September 25, 2008
Results First Received: October 22, 2013
Last Updated: June 25, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Inadequately controlled severe asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014