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Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients

2014-07-23 21:13:26 | BioPortfolio

Summary

The purpose of this study is to demonstrate the clinical equivalence of formoterol-HFA pMDI 12µg/actuation administered twice daily to formoterol DPI 12µg/capsule delivered by the Aerolizer inhaler and administered twice daily in patients with COPD.

Description

Phase III, multicenter, multinational, double-blind, double-dummy, randomised, 2-arm parallel-group, 3-month study in patients with stable COPD.

Comparison in terms of efficacy and safety of the two formulations of formoterol administered as 24µg/day in a bid regimen

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

Intervention

Formoterol, Formoterol

Location

Prof. Iwona Graelewska Rzymowska
Lodz
Lódz
Poland
91-520

Status

Completed

Source

Chiesi Farmaceutici S.p.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:26-0400

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Medical and Biotech [MESH] Definitions

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.

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.

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

A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.

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