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OpenTrials
Completed

NCT Number: NCT00465959

Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

To assess the effect of a single dose of TrIP on pulmonary function in patients with COPD

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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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

United States Investigational Site

Spartanburg, South Carolina, United States

Who can participate

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

Inclusion criteria

  • Male or female COPD patients between the ages of 40 and 80 years
  • Smoking history of at least 10 pack years
  • Not currently using (or able to wash out of) any long acting bronchodilators

Exclusion criteria

  • Candidate on a waiting list for surgery while on study
  • Using long-term oxygen therapy
  • Hospitalization for COPD exacerbation

Treatment and study plan

trospium chloride inhalation powder (TrIP)

Drug

Placebo

Drug

Primary outcomes

  1. Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 27, 2007
Registry last updated
Dec 27, 2013

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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