Effect of Tiotropium Inhalation Capsules (Spiriva) on Exercise Tolerance in COPD Patients

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00157235
First received: September 7, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Tiotropium bromide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind , Placebo Controlled Trial to Compare the Effect of Tiotropium Inhalation Capsules on Exercise Tolerance in Patients With COPD Participating in 8 Weeks of Pulmonary Rehabilitation

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in six minute walk distance after 8 weeks of pulmonary rehabilitation. [ Time Frame: week 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Individual FEV1 measurement [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Individual FVC measurement [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • St. George's Hospital Respiratory Questionnaire (SGRQ) [ Time Frame: Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Transition dyspnea index [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Amount of salbutamol therapy used during the treatment period [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Number and length of exacerbations of COPD [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Physician's global evaluation [ Time Frame: week 4, 13, 25 ] [ Designated as safety issue: No ]
  • Patient peak flow rates (PEFR) twice daily [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Patient activity measurement [ Time Frame: week 4, 9, 13, 17, 21, 25 ] [ Designated as safety issue: No ]
  • Six minute walk distance [ Time Frame: week 13, 25 ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in Pulse rate and blood pressure in conjunction with spirometry [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]
  • Changes in the physical examination from baseline and at the conclusion of patient participation in the trial [ Time Frame: 25 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 234
Study Start Date: September 2002
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:

This is an 25-week multicenter, single country, randomised, double-blind, placebo-controlled, parallel group study to compare the efficacy of tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio) in patients with COPD participating in a pulmonary rehabilitation program.

Following an initial screening, patients will perform a six minute walk test (Visit 1) and enter a 4-week run-in period. Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks. After successfully completing 4 weeks of study drug self-administration, patients will enter a period of pulmonary rehabilitation.

Pulmonary rehabilitation will include aerobic lower limb exercise 3 times weekly for 8 weeks. After the last pulmonary rehabilitation session, patients will continue on study medication for a 12 week follow-up period.

Six minute walk tests will be repeated during the run-in period at Week 0 (Visit 2) and Week 4 (Visit 3), at the conclusion of the 8 weeks of pulmonary rehabilitation (Visit 6) and the 12 weeks of follow-up (Visit 9).

Pulmonary function testing will be conducted prior to the start of therapy at Visit 1 and at Visits 2 (week 0 ), 3 (week 4 ), 6 (week 13 ) and 9 (week 25 ).

Study Hypothesis:

The null hypothesis is that there is no difference in the increase in six minute walk distance between tiotropium and placebo groups following 8 weeks pulmonary rehabilitation program. The alternative hypothesis is that tiotropium with pulmonary rehabilitation increases six minute walk distance more than placebo with pulmonary rehabilitation. However, the two-sided test of hypothesis will be performed at 0.05 level of significance.

Comparison(s):

The primary endpoint is the six minute walk distance at visit 6. This endpoint will be compared between tiotropium and placebo using an analysis of covariance model with treatment, center and baseline (six-minute walk distance measured at visit 2 prior to dosing) as a covariate. Fifty-four meters has been determined to be the difference in six minute walk distance between tiotropium (Spiriva, Bromuro de Tiotropio) and placebo at 5% level of significance with at least 80% power using a two-tailed t-test.. .

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.

Exclusion Criteria:

  • Patients with any respiratory infection in the six weeks prior to the Screening Visit or during the run-in period (between Visits 1 and 2).
  • Patients with a recent history (i.e., 6 months - or less) of myocardial infarction.
  • Patients with any cardiac arrhythmia requiring drug therapy in the past year or who have been hospitalized for heart failure within the past three years.
  • Patients with symptomatic benign prostatic hypertrophy or bladder neck obstruction.
  • Patients with known narrow-angle glaucoma.
  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: NCT00157235

Locations
Italy
Fondazione "S. Maugeri"
Bari, Italy, 70020
Azienda Sanitaria Locale
Casorate Primo (PV), Italy, 27022
Arcispedale S. Anna
Ferrara, Italy, 44100
U.O. dimedicina Preventiva del Lavoro
Genova, Italy, 16132
Fondazione Maugeri
Gussago (BS), Italy, 25064
Universita degli Studi di Pisa
Pisa, Italy, 56124
Fondazione Don Gnocchi
Pozzolatico (fi), Italy, 50020
Azienda Ospedaliera S. Camillo Forlanini
Roma, Italy, 00149
Fondazione S. Maugeri
Telese Terme (BN), Italy, 82037
Fondazione "S. Maugeri"
Tradate (VA), Italy, 21049
Ospedali Riuniti di Trieste
Trieste, Italy, 34100
Casa di Cura San Raffaele
Velletri (Roma), Italy, 00049
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator BI Italy
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00157235     History of Changes
Other Study ID Numbers: 205.247
Study First Received: September 7, 2005
Last Updated: October 31, 2013
Health Authority: Italy: Ministry of Health - Agenzia Italiana del Farmaco

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bromides
Tiotropium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 21, 2014