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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 15, 2012
Last verified: June 2012
History of Changes
  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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Rate of severe asthma exacerbations [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Asthma symptoms [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]
  • Rescue medication use [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]
  • Peakflow measurements [ Time Frame: Morning and Evening ] [ Designated as safety issue: No ]
  • Pre-and postbronchodilatation spirometry [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]
  • Exhaled NO (FeNO) [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]
  • Asthma control (ACQ) [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]
  • Asthma-related quality of life (AQLQ) [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]
  • Number of severe asthma exacerbations [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: Yes ]
  • Time to first severe asthma exacerbation [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: Yes ]
  • Total dose of systemic corticosteroid use [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]
  • Total number of acute upper and lower respiratory tract infections treated with antibiotics (other than macrolides) [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]
  • Health-economic evaluation (use of health care resources and EQ-5D) [ Time Frame: Over 6 months treatment period ] [ Designated as safety issue: No ]

Enrollment: 121
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: 1
Azithromycin 250 mg
 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: 2
Placebo
 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
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:
Website of the Ghent University Hospital  This link exits the ClinicalTrials.gov site

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
Last Updated: June 15, 2012
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 June 18, 2013