Phase 4 N=126 Randomized Double-blind Treatment

Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

Bottom Line

View on ClinicalTrials.gov: NCT01072396 ↗

Enrolled (actual)

126

Serious AEs

1.2%

Results posted

May 2013

Primary outcome: Primary: Change From Baseline in Inspiratory Capacity (IC) at Isotime — 0.0035; 0.07 liter — p=0.0087

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tiotropium (Drug); Placebo (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Boehringer Ingelheim
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Inspiratory Capacity (IC) at Isotime	0.0035; 0.07	0.0087 sig
SECONDARY Constant Work Rate (CWR) Endurance Time	6.0796; 6.1458	0.0670
SECONDARY Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime	-0.0485; -0.2544	0.2417

Summary

Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.

Eligibility Criteria

Inclusion criteria

For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio /=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion criteria

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.

Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01072396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.