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Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma

2014-08-27 03:14:45 | BioPortfolio

Summary

A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.

Description

This is a study involving a 2-4 week run-in phase followed by a 12 week double blind treatment phase. During the run-in phase, subjects receive Flixotide®. In the treatment phase subjects will be randomised to one of the two treatment groups and will receive either FlutiForm® and placebo inhaler for symbicort® turbohaler® or symbicort® turbohaler® and placebo inhaler for Flutiform ® . Efficacy will be assessed by lung function tests, asthma symptoms, sleep disturbance due to asthma and rescue medication use. Safety will be assessed by adverse events, lab tests, ECGs and vital signs.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Asthma

Intervention

Flutiform, Symbicort Turbohaler

Status

Not yet recruiting

Source

Mundipharma Research Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:45-0400

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