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A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol.

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ClinicalTrials.gov Identifier: NCT00274560
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : November 11, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:
The objective of the study was to evaluate the degree of improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) after treatment with tiotropium inhalation capsules compared to salmeterol inhalation aerosol .

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Tiotropium Drug: Salmeterol Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 653 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multiple Dose Comparison of Tiotropium Inhalation Capsules and Salmeterol Inhalation Aerosol in a 12 Week, Randomized, Double-Blind, Double-Dummy Parallel Group Study in Patients With Chronic Obstructive Pulmonary Disease (COPD).
Study Start Date : May 2002
Primary Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12) [ Time Frame: 12 weeks ]
  2. peak FEV1 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing [ Time Frame: 12 weeks ]
  2. Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day [ Time Frame: 12 weeks ]
  3. Individual FEV1 and FVC measurements at each timepoint [ Time Frame: 12 weeks ]
  4. Number (%) of patients with at least one exacerbation of COPD [ Time Frame: 12 weeks ]
  5. time to first exacerbation [ Time Frame: 12 weeks ]
  6. number of exacerbations [ Time Frame: 12 weeks ]
  7. number of exacerbation days [ Time Frame: 12 weeks ]
  8. Average daily occasions of rescue medication [albuterol (salbutamol)] use each week [ Time Frame: 12 weeks ]
  9. All adverse events [ Time Frame: 12 weeks ]
  10. Pulse rate measured in conjunction with spirometry [ Time Frame: 12 weeks ]
  11. Blood pressure (seated) measured in conjunction with spirometry [ Time Frame: 12 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274560


  Show 50 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
More Information

ClinicalTrials.gov Identifier: NCT00274560     History of Changes
Other Study ID Numbers: 205.264
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiration Disorders
Pathologic Processes
Disease Attributes
Tiotropium Bromide
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents