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OpenTrials
Completed

NCT Number: NCT00462540

A Crossover Study in the Treatment of Patients With COPD

The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of COPD
  • Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
  • Meet lung function requirements

Exclusion criteria

  • Diagnosis of Asthma
  • Significant disease other than COPD
  • Female pregnant or lactating or planning to become pregnant

Treatment and study plan

Formoterol Fumurate inhalation solution 20 mcg

Drug

Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg

Drug

Primary outcomes

  1. Lung function after 2 weeks of treatment

Secondary outcomes

  1. Lung function at each time point, patient questionnaires, medication compliance,

  2. adverse events, clinical labs, vital signs, ECGs, physical exams

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Sponsors and collaborators

Lead sponsor

Dey

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 19, 2007
Registry last updated
Mar 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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