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

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00465959
First received: April 24, 2007
Last updated: December 3, 2013
Last verified: July 2011

April 24, 2007
December 3, 2013
April 2007
June 2007   (final data collection date for primary outcome measure)
Safety and efficacy (measured by spirometry) of TrIP will be assessed in patients with chronic obstructive pulmonary disease.
Same as current
Complete list of historical versions of study NCT00465959 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Trospium Chloride Inhalation Powder (TrIP) in Patients With Chronic Obstructive Pulmonary Disease
Safety, Tolerability, Pharmacokinetics, and Efficacy of Single Inhaled Administrations 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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: trospium chloride inhalation powder (TrIP)
  • Drug: Placebo
  • Experimental: 400 mg TrIP
    Intervention: Drug: trospium chloride inhalation powder (TrIP)
  • Experimental: 800 mg TrIP
    Intervention: Drug: trospium chloride inhalation powder (TrIP)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2007
June 2007   (final data collection date for primary outcome measure)

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
Both
40 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00465959
IP631-024
Not Provided
Endo Pharmaceuticals
Endo Pharmaceuticals
Alkermes
Not Provided
Endo Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP