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About
The purpose of this study was to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, asthma related intubations, and asthma related deaths) in adolescents and adults (12 years of age and older) taking inhaled formoterol fumarate/fluticasone propionate combination was the same as those taking inhaled fluticasone propionate alone.
Full description
This was a 26 week, double blind, randomized, active-controlled safety study of Foradil in free combination with inhaled corticosteroid versus an inhaled corticosteroid alone in adults and adolescent patients with persistent asthma. The primary objective of the study was to demonstrate that the addition of formoterol fumarate to fluticasone propionate is non-inferior to fluticasone propionate alone in terms of the risk of composite serious asthma related events (asthma-related hospitalization, asthma-related intubation, and asthma-related death). The individual components of the composite primary endpoint (i.e., asthma-related hospitalization, asthma-related intubation and asthma-related death) will be assessed as a secondary safety endpoints.
The efficacy assessment is the secondary objective.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Written informed consent, and assent if applicable, must be obtained before any assessment is performed.
Male or female patients 12 years of age and older
Confirmed diagnosis of persistent asthma, as defined by national and international asthma guidelines (e.g., GINA; NIH; etc.) for at least 1 year prior to study enrollment.
PEF≥50% of predicted normal value.
Current and appropriate use of one of the treatments listed in the protocol for asthma.
Recent asthma exacerbation between 30 days and 12 months prior to randomization that either:
Key Exclusion Criteria:
Primary purpose
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Interventional model
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827 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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