A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)

Boehringer Ingelheim62 sites in 9 countries519 target enrollmentAugust 2007

ConditionsPulmonary Disease, Chronic Obstructive Exercise

Interventionstiotropium 18 mcg Placebo

Drugstiotropium 18 mcg Placebo

Overview

Phase: Phase 4
Intervention: tiotropium 18 mcg
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Enrollment: 519
Locations: 62
Primary Endpoint: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

June 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

tiotropium 18mcg

Oral inhalation once daily of 18mcg tiotropium via handihaler

Intervention: tiotropium 18 mcg

Placebo

Oral inhalation once daily of placebo matching tiotropium via handihaler

Intervention: Placebo

Outcomes

Primary Outcomes

90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase

Time Frame: baseline, 96 weeks

Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Secondary Outcomes

Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase(baseline, 96 weeks)
Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status(From first drug administration until 30 days after last drug administration)
90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase(baseline, 100 weeks)