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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157235
• Other study ID #: 205.247
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: December 27, 2017
• Start date: September 2002
• Est. completion date: April 2006

Study information

• Verified date: December 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium bromide

Locations

Country	Name	City	State
Italy	Fondazione "S. Maugeri"	Bari
Italy	Azienda Sanitaria Locale	Casorate Primo (PV)
Italy	Arcispedale S. Anna	Ferrara
Italy	U.O. dimedicina Preventiva del Lavoro	Genova
Italy	Fondazione Maugeri	Gussago (BS)
Italy	Universita degli Studi di Pisa	Pisa
Italy	Fondazione Don Gnocchi	Pozzolatico (FI)
Italy	Azienda Ospedaliera S. Camillo Forlanini	Roma
Italy	Fondazione S. Maugeri	Telese Terme (BN)
Italy	Fondazione "S. Maugeri"	Tradate (VA)
Italy	Ospedali Riuniti di Trieste	Trieste
Italy	Casa di Cura San Raffaele	Velletri (Roma)

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in six minute walk distance after 8 weeks of pulmonary rehabilitation.		week 13
Secondary	Individual FEV1 measurement		week 4, 13, 25
Secondary	Individual FVC measurement		week 4, 13, 25
Secondary	St. George's Hospital Respiratory Questionnaire (SGRQ)		Time Frame: week 4, 13, 25
Secondary	Transition dyspnea index		week 4, 13, 25
Secondary	COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest		week 4, 13, 25
Secondary	Amount of salbutamol therapy used during the treatment period		25 weeks
Secondary	Number and length of exacerbations of COPD		25 weeks
Secondary	Physician's global evaluation		week 4, 13, 25
Secondary	Patient peak flow rates (PEFR) twice daily		25 weeks
Secondary	Patient activity measurement		week 4, 9, 13, 17, 21, 25
Secondary	Six minute walk distance		week 13, 25
Secondary	Occurrence of adverse events		25 weeks
Secondary	Changes from baseline in Pulse rate and blood pressure in conjunction with spirometry		25 weeks
Secondary	Changes in the physical examination from baseline and at the conclusion of patient participation in the trial		25 weeks

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