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Sponsors and Collaborators: |
University Hospital, Ghent Institute for the Promotion of Innovation by Science and Technology in Flanders (IWT) |
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Information provided by: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT00760838 |
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 |
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Asthma |
Drug: Azithromycin 250 mg Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 150 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Azithromycin 250 mg
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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
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hermine Middendorp | Hermine.middendorp@uzgent.be |
Belgium | |
Ghent University Hospital | Recruiting |
Ghent, Belgium, 9000 | |
Principal Investigator: Guy Brusselle, MD, PhD | |
Universitair Ziekenhuis Leuven | Recruiting |
Leuven, Belgium, 3000 | |
Principal Investigator: Geert Verleden, MD, PhD | |
AZ Sint-Jan Brugge | Recruiting |
Brugge, Belgium, 8000 | |
Principal Investigator: Veerle Ringoet, MD | |
Onze Lieve Vrouw Ziekenhuis Aalst | Recruiting |
Aalst, Belgium, 9300 | |
Principal Investigator: Paul Jordens, MD | |
ZNA Middelheim | Recruiting |
Antwerpen, Belgium, 2020 | |
Principal Investigator: Hans Slabbynck, MD | |
AZ Groeninge | Recruiting |
Kortrijk, Belgium, 8500 | |
Principal Investigator: René Deman, MD |
Principal Investigator: | Guy Brusselle, MD, PhD | Ghent University Hospital |
Responsible Party: | Ghent University Hospital ( Guy Brusselle ) |
Study ID Numbers: | 2008/445, IWT 070709 |
Study First Received: | September 25, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00760838 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board |
Inadequately controlled severe asthma |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Azithromycin |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Anti-Infective Agents Anti-Bacterial Agents Immune System Diseases |
Bronchial Diseases Therapeutic Uses Pharmacologic Actions |