Effects of Tiotropium on Walking Capacity in Patients With COPD

NCT01307189 | Completed Phase 4

• 1 other identifier: CER1199
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to test the following hypothesis: A) The acute and long-term (3 weeks) bronchodilator-induced changes in exercise tolerance and in the physiological response during the endurance shuttle walk will be greater with tiotropium compared to placebo in COPD patients. B) Three weeks of bronchodilation will be associated with increase activity of daily living as evaluated using the London Chest Activity Daily Living scale.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease (COPD); Exercise; Endurance shuttle walking test; Bronchodilation; Tiotropium

Outcome Measures

Primary Outcomes (1)

• Endurance time during an endurance shuttle walk

  acute response (2.5 hours) following the administration of the active and comparison drug

Secondary Outcomes (3)

• Compare the long-term bronchodilator-induced changes in exercise tolerance during the endurance shuttle walk

  three weeks

• Evaluate the impact of long-term bronchodilation on activity of daily living evaluated using the London Chest Activity Daily Living scale

  three weeks

• Cardio-respiratory responses during an endurance shutlle walk

  acute response following the administration of the study medication

Study Arms (2)

Tiotropium

ACTIVE COMPARATOR

Drug: Tiotropium

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Tiotropium DRUG

Tiotropium diskus inhalation powder, 18ug, once daily

Also known as: Spiriva

Tiotropium

Placebo DRUG

Placebo diskus inhalation powder, once daily

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 50 years, smoking history \> 10 packs/year, FEV1 \< 70% of predicted and FEV1/FVC \< 70%.

You may not qualify if:

• respiratory exacerbation within the 2 months preceding the study, history of asthma, significant O2 desaturation (SaO2 \< 85%) at rest or during exercise, presence of another pathology that could influence exercise tolerance.

Sponsors & Collaborators

• Laval University: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Centre de recherche de l'IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• François Maltais, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 2, 2011
• Study Start: April 1, 2005
• Study Completion: August 1, 2010
• Last Updated: March 2, 2011

Record last verified: 2010-08

Locations

CA (1)