Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
Public ClinicalTrials.gov record NCT01072396. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01072396
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 126 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2010
- Primary completion
- Oct 31, 2011
- Completion
- Oct 31, 2011
- Last update posted
- Dec 23, 2013
2010 – 2011
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 205.440.1006 Boehringer Ingelheim Investigational Site | Birmingham | Alabama | — | — |
| 205.440.1015 Boehringer Ingelheim Investigational Site | Jasper | Alabama | — | — |
| 205.440.1002 Boehringer Ingelheim Investigational Site | Torrance | California | — | — |
| 205.440.1018 Boehringer Ingelheim Investigational Site | Hartford | Connecticut | — | — |
| 205.440.1008 Boehringer Ingelheim Investigational Site | Springfield | Illinois | — | — |
| 205.440.1017 Boehringer Ingelheim Investigational Site | Muncie | Indiana | — | — |
| 205.440.1020 Boehringer Ingelheim Investigational Site | Livonia | Michigan | — | — |
| 205.440.1011 Boehringer Ingelheim Investigational Site | Lebanon | New Hampshire | — | — |
| 205.440.1019 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina | — | — |
| 205.440.1013 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania | — | — |
| 205.440.1007 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01072396, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 23, 2013 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01072396 live on ClinicalTrials.gov.