Tiotropium In Exercise

NCT00525512

Last updated date
Study Location
205.368.01023 Boehringer Ingelheim Investigational Site
Jasper, Alabama, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Obstructive Pulmonary Disease, Exercise
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Chronic Obstructive Pulmonary Disease, ExerciseTiotropium In Exercise
NCT00525512
  1. Jasper, Alabama
  2. Phoenix, Arizona
  3. Los Angeles, California
  4. Fort Collins, Colorado
  5. Hartford, Connecticut
  6. Waterbury, Connecticut
  7. Bay Pines, Florida
  8. North Miami Beach, Florida
  9. Hazard, Kentucky
  10. Biddeford, Maine
  11. Baltimore, Maryland
  12. Boston, Massachusetts
  13. Kansas City, Missouri
  14. Albany, New York
  15. Tulsa, Oklahoma
  16. Charleston, South Carolina
  17. Gaffney, South Carolina
  18. Greenville, South Carolina
  19. Spartanburg, South Carolina
  20. Union, South Carolina
  21. Dallas, Texas
  22. Rosario,
  23. Vicente López,
  24. Goiânia,
  25. Porto Alegre - RS,
  26. Sao Paulo,
  27. Vancouver, British Columbia
  28. Winnipeg, Manitoba
  29. Winnipeg, Manitoba
  30. Hamilton, Ontario
  31. Hamilton, Ontario
  32. Montreal, Quebec
  33. Berlin,
  34. Freiburg/Breisgau,
  35. Köln,
  36. Münster,
  37. Schmallenberg,
  38. Tübingen,
  39. Ferrara,
  40. Milano,
  41. Parma,
  42. Pisa,
  43. Coimbra,
  44. Matosinhos,
  45. Moscow,
  46. Moscow,
  47. Moscow,
  48. Moscow,
  49. St. Petersburg,
  50. Badalona (Barcelona),
  51. Barakaldo (Bilbao),
  52. Barcelona,
  53. Madrid,
  54. Sevilla,
  55. Sevilla,
  56. Keelung,
  57. Taichung,
  58. Taipei City,
  59. Taoyuan,
  60. Dnyepropyetrovsk,
  61. Kiev,
  62. Kiev,
ALL GENDERS
40 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Pulmonary Disease, Chronic Obstructive
  • Exercise
Intervention  ICMJE
  • Drug: tiotropium 18 mcg
    Oral inhalation once daily of 18mcg tiotropium via handihaler
  • Drug: Placebo
    Oral inhalation of once-daily placebo matching tiotropium via handihaler
Study Arms  ICMJE
  • Experimental: tiotropium 18mcg
    Oral inhalation once daily of 18mcg tiotropium via handihaler
    Intervention: Drug: tiotropium 18 mcg
  • Placebo Comparator: Placebo
    Oral inhalation once daily of placebo matching tiotropium via handihaler
    Intervention: Drug: Placebo
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
 (submitted: November 5, 2008)
519
Original Enrollment  ICMJE
 (submitted: September 3, 2007)
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

  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

Exclusion criteria

  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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Chair:Boehringer IngelheimBoehringer Ingelheim
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