Tiotropium In Exercise

NCT00525512 | Completed Phase 4 Results

• 2 other identifiers: 205.3682006-004610-41
• Study Type: interventional
• Target: 519
• Locations: 11 countries
• Sites: 62

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.

Conditions

Pulmonary Disease, Chronic Obstructive; Exercise

Outcome Measures

Primary Outcomes (1)

• 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase

  Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  baseline, 96 weeks

Secondary Outcomes (64)

• 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase

  baseline, 8 weeks

• 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase

  baseline, 16 weeks

• 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase

  baseline, 32 weeks

• 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase

  baseline, 48 weeks

• 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase

  baseline, 64 weeks

Study Arms (2)

tiotropium 18mcg

EXPERIMENTAL

Oral inhalation once daily of 18mcg tiotropium via handihaler

Drug: tiotropium 18 mcg

Placebo

PLACEBO COMPARATOR

Oral inhalation once daily of placebo matching tiotropium via handihaler

Drug: Placebo

Interventions

tiotropium 18 mcg DRUG

Oral inhalation once daily of 18mcg tiotropium via handihaler

tiotropium 18mcg

Placebo DRUG

Oral inhalation of once-daily placebo matching tiotropium via handihaler

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must sign an informed consent
• Diagnosis of COPD with specific spirometric criteria (determined at study visits)
• Age \>= 40 years
• Medical Research Council Dyspnoea score \>= 2
• Current or ex-smoker with a \>= 10 pack-year smoking history
• Ability to exercise on treadmill

You may not qualify if:

• 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
• Clinical history of asthma
• Use of supplemental oxygen therapy
• 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)
• Recent history (\<= 12 months) of myocardial infarction
• Unstable or life-threatening cardiac arrhythmia
• Malignancy treated with radiation therapy or chemotherapy in the last 5 years
• Pregnant or nursing women
• Known hypersensitivity to anticholinergic drugs or any component of the study medications
• Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
• Estimated life expectancy \< 2 years
• Symptomatic prostatic hyperplasia or bladder neck obstruction
• Known narrow-angle glaucoma
• Any condition that is contraindicated for exercise
• Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Pfizer: collaborator

Study Sites (62)

205.368.01023 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

205.368.01022 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

205.368.01003 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

205.368.01008 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Location

205.368.01017 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

205.368.01028 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

205.368.01004 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

Location

205.368.01013 Boehringer Ingelheim Investigational Site

North Miami Beach, Florida, United States

Location

205.368.01025 Boehringer Ingelheim Investigational Site

Hazard, Kentucky, United States

Location

205.368.01029 Boehringer Ingelheim Investigational Site

Biddeford, Maine, United States

Location

205.368.01016 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

205.368.01002 Boehringer Ingelheim Investigational Site

Boston, Massachusetts, United States

Location

205.368.01021 Boehringer Ingelheim Investigational Site

Kansas City, Missouri, United States

Location

205.368.01014 Boehringer Ingelheim Investigational Site

Albany, New York, United States

Location

205.368.01030 Boehringer Ingelheim Investigational Site

Tulsa, Oklahoma, United States

Location

205.368.01018 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

205.368.01027 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Location

205.368.01019 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

205.368.01020 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

205.368.01024 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

205.368.01015 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

205.368.54001 Boehringer Ingelheim Investigational Site

Rosario, Argentina

Location

205.368.54002 Boehringer Ingelheim Investigational Site

Vicente López, Argentina

Location

205.368.55003 Boehringer Ingelheim Investigational Site

Goiânia, Brazil

Location

205.368.55004 Boehringer Ingelheim Investigational Site

Porto Alegre - RS, Brazil

Location

205.368.55002 Boehringer Ingelheim Investigational Site

São Paulo, Brazil

Location

205.368.07006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

205.368.07001 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

205.368.07003 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

205.368.07004 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

205.368.07005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

205.368.07008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

205.368.49005 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

205.368.49003 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

205.368.49004 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, Germany

Location

205.368.49006 Boehringer Ingelheim Investigational Site

Münster, Germany

Location

205.368.49002 Boehringer Ingelheim Investigational Site

Schmallenberg, Germany

Location

205.368.49001 Boehringer Ingelheim Investigational Site

Tübingen, Germany

Location

205.368.39006 Boehringer Ingelheim Investigational Site

Ferrara, Italy

Location

205.368.39004 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

205.368.39002 Boehringer Ingelheim Investigational Site

Parma, Italy

Location

205.368.39001 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

205.368.35103 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

205.368.35102 Boehringer Ingelheim Investigational Site

Matosinhos Municipality, Portugal

Location

205.368.70001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.368.70004 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.368.70005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.368.70006 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

205.368.70007 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

205.368.34005 Hospital Germans Trias i Pujol

Badalona (Barcelona), Spain

Location

205.368.34002 Hospital de Cruces

Barakaldo (Bilbao), Spain

Location

205.368.34001 Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Location

205.368.34003 Hospital Gregorio Maranon

Madrid, Spain

Location

205.368.34004 Hospital Universitario Vírgen del Rocío

Seville, Spain

Location

205.368.34006 Boehringer Ingelheim Investigational Site

Seville, Spain

Location

205.368.88604 Boehringer Ingelheim Investigational Site

Keelung, Taiwan

Location

205.368.88602 Boehringer Ingelheim Investigational Site

Taichung, Taiwan

Location

205.368.88603 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

205.368.88601 Chang Gung Memorial Hosp-Linkou

Taoyuan District, Taiwan

Location

205.368.38003 Boehringer Ingelheim Investigational Site

Dnyepropyetrovsk, Ukraine

Location

205.368.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

205.368.38002 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 23558890 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 3, 2007
• First Posted: September 5, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2010
• Last Updated: December 24, 2013
• Results First Posted: September 23, 2011

Record last verified: 2013-09

Locations

ES (6); PT (2); UA (3); CA (6); BR (3); RU (5); TW (4); AR (2); IT (4); US (21); DE (6)