Effect of Bronchodilation on Cycle vs Treadmill Exercise Endurance Time in COPD

NCT00754546 | Completed Phase 4 Results DMC

• 1 other identifier: 21261
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Previous studies suggest that treadmill exercise may be a more relevant exercise stimulus than the cycle ergometer to demonstrate benefits with bronchodilator therapy in patients with COPD. The hypothesis of the study is that patients with COPD will exhibit greater improvements in exercise endurance and breathlessness with arformoterol compared with normal saline during treadmill walking than with cycle exercise.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

exercise;; treadmill;; cycle ergometer;; breathlessness;; leg discomfort

Outcome Measures

Primary Outcomes (1)

• Exercise Endurance Time

  Participants were asked to exercise until symptom limitation

  After one dose

Secondary Outcomes (1)

• Linear Regression Between Breathlessness Ratings (on 0 - 10 Borg Scale) and Time Throughout Exercise

  After one dose

Study Arms (2)

Arformoterol tartrate

ACTIVE COMPARATOR

Bronchodilator therapy with arformoterol solution 15 mcg

Drug: Arformoterol tartrate; Other: Treadmill Exercise; Other: Cycle Exercise

Normal saline

PLACEBO COMPARATOR

Placebo using normal saline

Drug: Placebo: Normal Saline; Other: Treadmill Exercise; Other: Cycle Exercise

Interventions

Arformoterol tartrate DRUG

15 mcg in two ml solution administered via nebulizer

Also known as: Brovana

Arformoterol tartrate

Placebo: Normal Saline DRUG

Normal saline was nebulized.

Normal saline

Treadmill Exercise OTHER

Arformoterol tartrate; Normal saline

Cycle Exercise OTHER

Arformoterol tartrate; Normal saline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female patient 50 years of age or older; diagnosis of COPD; current or ex-smoker with at least 10 pack-years of smoking; a patient-reported score for breathlessness during activities of daily living of \< 9 on the self-administered computerized baseline dyspnea index; a post-bronchodilator FEV1 \< 80% predicted; a post-bronchodilator FEV1/FVC ratio \< 70%; and clinically stable condition.

You may not qualify if:

• any concomitant disease that interferes with study procedures or evaluation; inability to exercise on the treadmill or cycle ergometer; inability to withhold short-acting bronchodilators for 4 hours or long-acting bronchodilators for 12 hrs (salmeterol or formoterol) and for 24 hours (tiotropium) prior to testing

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0001, United States

Location

Related Publications (1)

• Zhang X, Waterman LA, Ward J, Baird JC, Mahler DA. Advantages of endurance treadmill walking compared with cycling to assess bronchodilator therapy. Chest. 2010 Jun;137(6):1354-61. doi: 10.1378/chest.09-2470. Epub 2009 Dec 29.

  PMID: 20040610 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Dyspnea

Interventions

Formoterol Fumarate; Plyometric Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Study completed with no reported adverse effects. One limitation of the study is frequent exercise tests involving 7 visits for each participant

Results Point of Contact

• Title: Donald A. Mahler, M.D.
• Organization: Dartmouth-Hitchcock Medical Center

Donald.a.mahler@hitchcock.org

603 650-5533

Study Officials

• Doanld A Mahler, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2008
• First Posted: September 18, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 29, 2013
• Results First Posted: May 29, 2013

Record last verified: 2013-05

Locations

US (1)