ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. All patients must sign an informed consent
2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)
3. Age >= 40 years
4. Medical Research Council Dyspnoea score >= 2
5. Current or ex-smoker with a >= 10 pack-year smoking history
6. Ability to exercise on treadmill
1. Significant diseases other than COPD such as history of life-threatening pulmonary
obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF,
pulmonary thromboembolic disease, clinically evident bronchiectasis, active
tuberculosis, or known moderate to severe renal impairment
2. Clinical history of asthma
3. Use of supplemental oxygen therapy
4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or
during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
5. Recent history (<= 12 months) of myocardial infarction
6. Unstable or life-threatening cardiac arrhythmia
7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years
8. Pregnant or nursing women
9. Known hypersensitivity to anticholinergic drugs or any component of the study
medications
10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
11. Estimated life expectancy < 2 years
12. Symptomatic prostatic hyperplasia or bladder neck obstruction
13. Known narrow-angle glaucoma
14. Any condition that is contraindicated for exercise
15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with
regular participation in aerobic exercise or with exercise testing
16. Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space
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Descriptive Information | ||||
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Brief Title ICMJE | Tiotropium In Exercise | |||
Official Title ICMJE | A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT) | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Cooper CB, Celli BR, Jardim JR, Wise RA, Legg D, Guo J, Kesten S. Treadmill endurance during 2-year treatment with tiotropium in patients with COPD: a randomized trial. Chest. 2013 Aug;144(2):490-497. doi: 10.1378/chest.12-2613. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 519 | |||
Original Enrollment ICMJE | 460 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion criteria
Exclusion criteria
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Sex/Gender ICMJE |
| |||
Ages ICMJE | 40 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Brazil, Canada, Germany, Italy, Portugal, Russian Federation, Spain, Taiwan, Ukraine, United States | |||
Removed Location Countries | Austria, Poland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00525512 | |||
Other Study ID Numbers ICMJE | 205.368 2006-004610-41 ( EudraCT Number: EudraCT ) | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | |||
Study Sponsor ICMJE | Boehringer Ingelheim | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Boehringer Ingelheim | |||
Verification Date | September 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |