Clinical trial NCT00525512: Tiotropium In Exercise
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Exercise
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2007-09-05
Enrollment: 519
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
Secondary outcomes:
measure: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
timeFrame: baseline, 8 weeks
measure: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase
timeFrame: baseline, 16 weeks
measure: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase
timeFrame: baseline, 32 weeks
measure: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase
timeFrame: baseline, 48 weeks
measure: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase
timeFrame: baseline, 64 weeks
measure: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase
timeFrame: baseline, 80 weeks
measure: Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
timeFrame: baseline, 8 weeks
measure: Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
timeFrame: baseline, 16 weeks
measure: Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
timeFrame: baseline, 32 weeks
measure: Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
timeFrame: baseline, 48 weeks
measure: Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
timeFrame: baseline, 64 weeks
measure: Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
timeFrame: baseline, 80 weeks
measure: Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
timeFrame: baseline, 8 weeks
measure: Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
timeFrame: baseline, 16 weeks
measure: Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
timeFrame: baseline, 32 weeks
measure: Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
timeFrame: baseline, 48 weeks
measure: Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
timeFrame: baseline, 64 weeks
measure: Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
timeFrame: baseline, 80 weeks
measure: Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
timeFrame: baseline, 8 weeks
measure: Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
timeFrame: baseline, 16 weeks
measure: Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
timeFrame: baseline, 32 weeks
measure: Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
timeFrame: baseline, 48 weeks
measure: Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
timeFrame: baseline, 64 weeks
measure: Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
timeFrame: baseline, 80 weeks
measure: Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
timeFrame: baseline, 8 weeks
measure: Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
timeFrame: baseline, 16 weeks
measure: Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
timeFrame: baseline, 32 weeks
measure: Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
timeFrame: baseline, 48 weeks
measure: Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
timeFrame: baseline, 64 weeks
measure: Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
timeFrame: baseline, 80 weeks
measure: Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase
timeFrame: baseline, 8 weeks
measure: Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase
timeFrame: baseline, 16 weeks
measure: Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase
timeFrame: baseline, 32 weeks
measure: Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase
timeFrame: baseline, 48 weeks
measure: Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase
timeFrame: baseline, 64 weeks
measure: Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase
timeFrame: baseline, 80 weeks
measure: Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase
timeFrame: baseline, 8 weeks
measure: Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase
timeFrame: baseline, 16 weeks
measure: Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase
timeFrame: baseline, 32 weeks
measure: Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase
timeFrame: baseline, 48 weeks
measure: Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase
timeFrame: baseline, 64 weeks
measure: Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase
timeFrame: baseline, 80 weeks
measure: Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase
timeFrame: baseline, 96 weeks
measure: 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase
timeFrame: baseline, 100 weeks
measure: Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase
timeFrame: baseline, 100 weeks
measure: Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase
timeFrame: baseline, 100 weeks
measure: Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase
timeFrame: baseline, 100 weeks
measure: Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase
timeFrame: baseline, 100 weeks
measure: Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase
timeFrame: baseline, 100 weeks
measure: Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase
timeFrame: baseline, 100 weeks
measure: Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status
timeFrame: From first drug administration until 30 days after last drug administration
Other outcomes:
Locations:
city: Jasper
country: United States
facility: 205.368.01023 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 205.368.01022 Boehringer Ingelheim Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: 205.368.01003 Boehringer Ingelheim Investigational Site
state: California
city: Fort Collins
country: United States
facility: 205.368.01008 Boehringer Ingelheim Investigational Site
state: Colorado
city: Hartford
country: United States
facility: 205.368.01017 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: 205.368.01028 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Bay Pines
country: United States
facility: 205.368.01004 Boehringer Ingelheim Investigational Site
state: Florida
city: North Miami Beach
country: United States
facility: 205.368.01013 Boehringer Ingelheim Investigational Site
state: Florida
city: Hazard
country: United States
facility: 205.368.01025 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Biddeford
country: United States
facility: 205.368.01029 Boehringer Ingelheim Investigational Site
state: Maine
city: Baltimore
country: United States
facility: 205.368.01016 Boehringer Ingelheim Investigational Site
state: Maryland
city: Boston
country: United States
facility: 205.368.01002 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Kansas City
country: United States
facility: 205.368.01021 Boehringer Ingelheim Investigational Site
state: Missouri
city: Albany
country: United States
facility: 205.368.01014 Boehringer Ingelheim Investigational Site
state: New York
city: Tulsa
country: United States
facility: 205.368.01030 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Charleston
country: United States
facility: 205.368.01018 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Gaffney
country: United States
facility: 205.368.01027 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 205.368.01019 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 205.368.01020 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Union
country: United States
facility: 205.368.01024 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: 205.368.01015 Boehringer Ingelheim Investigational Site
state: Texas
city: Rosario
country: Argentina
facility: 205.368.54001 Boehringer Ingelheim Investigational Site
city: Vicente López
country: Argentina
facility: 205.368.54002 Boehringer Ingelheim Investigational Site
city: Goiânia
country: Brazil
facility: 205.368.55003 Boehringer Ingelheim Investigational Site
city: Porto Alegre - RS
country: Brazil
facility: 205.368.55004 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 205.368.55002 Boehringer Ingelheim Investigational Site
city: Vancouver
country: Canada
facility: 205.368.07006 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: 205.368.07001 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: 205.368.07003 Boehringer Ingelheim Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: 205.368.07004 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 205.368.07005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 205.368.07008 Boehringer Ingelheim Investigational Site
state: Quebec
city: Berlin
country: Germany
facility: 205.368.49005 Boehringer Ingelheim Investigational Site
city: Freiburg/Breisgau
country: Germany
facility: 205.368.49004 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 205.368.49003 Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: 205.368.49006 Boehringer Ingelheim Investigational Site
city: Schmallenberg
country: Germany
facility: 205.368.49002 Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: 205.368.49001 Boehringer Ingelheim Investigational Site
city: Ferrara
country: Italy
facility: 205.368.39006 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 205.368.39004 Boehringer Ingelheim Investigational Site
city: Parma
country: Italy
facility: 205.368.39002 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 205.368.39001 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 205.368.35103 Boehringer Ingelheim Investigational Site
city: Matosinhos
country: Portugal
facility: 205.368.35102 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 205.368.70001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 205.368.70004 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 205.368.70005 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 205.368.70006 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 205.368.70007 Boehringer Ingelheim Investigational Site
city: Badalona (Barcelona)
country: Spain
facility: 205.368.34005 Hospital Germans Trias i Pujol
city: Barakaldo (Bilbao)
country: Spain
facility: 205.368.34002 Hospital de Cruces
city: Barcelona
country: Spain
facility: 205.368.34001 Hospital Clinic i Provincial de Barcelona
city: Madrid
country: Spain
facility: 205.368.34003 Hospital Gregorio Maranon
city: Sevilla
country: Spain
facility: 205.368.34004 Hospital Universitario Vírgen del Rocío
city: Sevilla
country: Spain
facility: 205.368.34006 Boehringer Ingelheim Investigational Site
city: Keelung
country: Taiwan
facility: 205.368.88604 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 205.368.88602 Boehringer Ingelheim Investigational Site
city: Taipei City
country: Taiwan
facility: 205.368.88603 Boehringer Ingelheim Investigational Site
city: Taoyuan
country: Taiwan
facility: 205.368.88601 Chang Gung Memorial Hosp-Linkou
city: Dnyepropyetrovsk
country: Ukraine
facility: 205.368.38003 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 205.368.38001 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 205.368.38002 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.