Tiotropium In Exercise

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00525512
First received: September 3, 2007
Last updated: November 27, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Exercise
Drug: tiotropium 18 mcg
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.


Secondary Outcome Measures:
  • 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  • 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  • 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase [ Time Frame: baseline, 32 weeks ] [ Designated as safety issue: No ]
    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  • 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  • 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase [ Time Frame: baseline, 64 weeks ] [ Designated as safety issue: No ]
    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  • 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase [ Time Frame: baseline, 80 weeks ] [ Designated as safety issue: No ]
    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  • Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase [ Time Frame: baseline, 32 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase [ Time Frame: baseline, 64 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase [ Time Frame: baseline, 80 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase [ Time Frame: baseline, 32 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase [ Time Frame: baseline, 64 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase [ Time Frame: baseline, 80 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase [ Time Frame: baseline, 32 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase [ Time Frame: baseline, 64 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase [ Time Frame: baseline, 80 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase [ Time Frame: baseline, 32 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase [ Time Frame: baseline, 64 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase [ Time Frame: baseline, 80 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

  • Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

  • Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

  • Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase [ Time Frame: baseline, 32 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase [ Time Frame: baseline, 64 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase [ Time Frame: baseline, 80 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase [ Time Frame: baseline, 8 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase [ Time Frame: baseline, 16 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase [ Time Frame: baseline, 32 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase [ Time Frame: baseline, 48 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase [ Time Frame: baseline, 64 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase [ Time Frame: baseline, 80 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  • Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  • Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  • Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  • Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  • Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase [ Time Frame: baseline, 96 weeks ] [ Designated as safety issue: No ]
    COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.

  • 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase [ Time Frame: baseline, 100 weeks ] [ Designated as safety issue: No ]
    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  • Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase [ Time Frame: baseline, 100 weeks ] [ Designated as safety issue: No ]
    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  • Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase [ Time Frame: baseline, 100 weeks ] [ Designated as safety issue: No ]
    FVC is the volume of air that can be forcibly blown out after full inspiration.

  • Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase [ Time Frame: baseline, 100 weeks ] [ Designated as safety issue: No ]
    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  • Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase [ Time Frame: baseline, 100 weeks ] [ Designated as safety issue: No ]
    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  • Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase [ Time Frame: baseline, 100 weeks ] [ Designated as safety issue: No ]
    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  • Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase [ Time Frame: baseline, 100 weeks ] [ Designated as safety issue: No ]
    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  • Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status [ Time Frame: From first drug administration until 30 days after last drug administration ] [ Designated as safety issue: No ]
    Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.


Enrollment: 519
Study Start Date: August 2007
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tiotropium 18mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
Drug: tiotropium 18 mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
Placebo Comparator: Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
Drug: Placebo
Oral inhalation of once-daily placebo matching tiotropium via handihaler

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525512

  Show 62 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Pfizer
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00525512     History of Changes
Other Study ID Numbers: 205.368, 2006-004610-41
Study First Received: September 3, 2007
Results First Received: June 27, 2011
Last Updated: November 27, 2013
Health Authority: Argentina: A.N.M.A.T. (National administration of Medecines, Foods and Medical Technology)
Brazil: ANVISA
Canada: Therapeutic Products Directorate
Germany: Federal Institute for Drug and Medicine Products
Italy: Comitato Etico dell'Azienda Osp. Universitaria Pisana
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Spain: Agencia Espanola de Medicamentos y Productos Santarios
Taiwan: Department of Health, Executive Yuan, Taiwan
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Tiotropium
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014