AZISAST Study: AZIthromycin in Severe ASThma Study - Full Text View

Sponsor:	University Hospital, Ghent
Collaborator:	IWT, Belgium
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00760838

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 IV

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

Drug Information available for: Azithromycin

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 ]

Estimated Enrollment:	150
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2012
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:

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

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

IWT, Belgium

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

Responsible Party:	Guy Brusselle, Ghent University Hospital
ClinicalTrials.gov Identifier:	NCT00760838 History of Changes
Other Study ID Numbers:	2008/445, IWT 070709
Study First Received:	September 25, 2008
Last Updated:	May 27, 2011
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 February 09, 2012