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Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)

2014-07-23 21:35:12 | BioPortfolio

Summary

This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). This is a 26 week Efficacy and Safety study with a 26 week safety extension. Efficacy is not measured for 52 weeks. Efficacy will be measured by the mean change from Baseline to Week 26 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]). Efficacy will also be measured by time-to-first COPD exacerbation over the 52-week Treatment Period for the comparison of MF/F versus F. Secondary efficacy variable will be COPD control scores from diary.

Study Design

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Intervention

Mometasone furoate/formoterol (MF/F) combination, Mometasone furoate/formoterol (MF/F) combination, Mometasone furoate MDI (MF MDI), Formoterol MDI, Placebo

Status

Active, not recruiting

Source

Schering-Plough

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:12-0400

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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.

A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

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An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

Inhibitor or Reverse Transcriptases or of RNA-dIrected DNA polymerase.

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