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Study to Assess Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adults With Mild to Moderate Asthma

2014-08-27 03:18:39 | BioPortfolio

Summary

This is a dose-response study to determine how various measurements of airway inflammation respond to high and low dose FlutiForm®, and compared to placebo.

Description

The study consists of two 4-week treatment periods, each preceded by a 14-21 wash-out period. Subjects will be randomised to receive two of the three study treatments - FlutiForm® pMDI 50/5 µg, FlutiForm® pMDI 250/10 µg, or placebo (dummy inhaler). During the wash-out periods, subjects will take only salbutamol, if required, as rescue medication.

Subjects will record a daily diary for PEFR, study medication use, rescue medication use, asthma symptom scores, and sleep disturbance due to asthma. Assessments performed at study clinic visits include inhaled adenosine 5'-monophosphate (AMP) challenge test, induced sputum test, exhaled nitric oxide (eNO) test, and spirometry tests. Safety will be assessed by lab tests, vital signs, ECG and adverse events.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Asthma

Intervention

Fluticasone propionate / Formoterol fumarate

Location

KLB
Lubeck
Germany

Status

Completed

Source

Mundipharma Research Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:39-0400

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of mometasone furoate and formoterol fumarate that is used as an inhaled dosage form for the treatment of ASTHMA.

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A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.

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