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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274560
First received: January 9, 2006
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium
Drug: Salmeterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • FEV1 area under the curve for the time period of 0 to 12 hours (FEV1 AUC0-12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • peak FEV1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FEV1: Trough FEV1 was the FEV1 measured prior to dosing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Trough and peak FVC and FVC AUC0-12 measured at the same times as FEV1 on each test day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Individual FEV1 and FVC measurements at each timepoint [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number (%) of patients with at least one exacerbation of COPD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • time to first exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • number of exacerbations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • number of exacerbation days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Average daily occasions of rescue medication [albuterol (salbutamol)] use each week [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • All adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Pulse rate measured in conjunction with spirometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood pressure (seated) measured in conjunction with spirometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 653
Study Start Date: May 2002
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274560

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274560     History of Changes
Other Study ID Numbers: 205.264
Study First Received: January 9, 2006
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014