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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00455923 |
An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.
Condition | Intervention | Phase |
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Asthma |
Drug: Seretide Drug: Flixotide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study |
Official Title: | SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII) |
Estimated Enrollment: | 100 |
Study Start Date: | May 2005 |
Study Completion Date: | July 2007 |
Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SAM103976, SAM103976 |
Study First Received: | April 3, 2007 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00455923 History of Changes |
Health Authority: | Sweden: Medical Products Agency |
mild persistent asthma |
GINAII exacerbation bronchial hyperresponsiveness |
Anti-Inflammatory Agents Bronchial Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Lung Diseases, Obstructive Hypersensitivity Respiratory Tract Diseases |
Lung Diseases Hypersensitivity, Immediate Fluticasone Bronchial Hyperreactivity Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Bronchial Diseases Immune System Diseases Physiological Effects of Drugs Anti-Asthmatic Agents Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive Hypersensitivity |
Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Respiratory Hypersensitivity |