Effect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsor:	Queen's University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00974220

Purpose

Breathing discomfort (dyspnea) and activity limitation are dominant symptoms of chronic obstructive pulmonary disease (COPD) and contribute to poor health-related quality of life in this population. Several small, uncontrolled studies and published case reports have provided evidence that inhaled fentanyl, a powerful pain relieving (opioid) medication, may be used to effectively reduce breathing discomfort in patients with advanced disease. However, the mechanisms of this improvement remain unclear. Therefore, the investigators plan to conduct the first randomized, double-blind, placebo-controlled, crossover study designed to explore the possible mechanisms of action of inhaled fentanyl on activity-related dyspnea and exercise performance in patients with advanced COPD.

Condition	Intervention
Chronic Obstructive Pulmonary Disease	Drug: fentanyl Drug: normal saline (placebo)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effect of Inhaled Nebulized Fentanyl on Exertional Dyspnea and Exercise Tolerance in Patients With Moderate-to-severe COPD

Resource links provided by NLM:

MedlinePlus related topics: Breathing Problems COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:

Dyspnea intensity measured by the 10-point Borg scale during cycle exercise [ Time Frame: 10-minutes post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cycle exercise endurance time [ Time Frame: 10-minutes post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	October 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo: Placebo Comparator nebulized 0.9% saline placebo	Drug: normal saline (placebo) single dose, 0.9% saline solution
fentanyl: Experimental nebulized fentanyl citrate (50 mcg)	Drug: fentanyl single dose, 50 mcg of nebulized fentanyl citrate

Eligibility

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

Criteria

Inclusion Criteria:

Post-bronchodilator forced expiratory volume in 1 sec (FEV1) 30-79% predicted, FEV1/forced vital capacity (FVC) ratio <70%;
Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks;
A cigarette smoking history ≥20 pack-years;
Significant chronic activity-related dyspnea as defined by a Baseline Dyspnea Index focal score ≤ 6;
Body mass index (BMI) between 18.5 and 30.0 kg/m2;
Able to perform all study procedures and provide/sign informed consent.

Exclusion Criteria:

A diffusing capacity of the lung for carbon monoxide (DLCO) <40 %predicted;
Presence of active cardiopulmonary disease other than COPD that could contribute to dyspnea and exercise limitation;
Clinical diagnosis of sleep disordered breathing;
A history/clinical evidence of asthma, atopy and/or nasal polyps;
History of allergy or adverse reaction to fentanyl;
Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air;
Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks;
Use of opioid or pain relieving drugs (e.g., morphine, fentanyl, oxycodone, hydromorphone, methadone, levorphanol, codeine, hydrocodone, meperidine) in previous 4 weeks.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974220

Contacts

Contact: Denis Jensen, Ph.D.	613-549-6666 ext 4910	jensend@queensu.ca
Contact: Kathy Webb, M.Sc.	613-549-6666 ext 4950	webbk@queensu.ca

Locations

Canada, Ontario
Respiratory Investigation Unit, Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7

Sponsors and Collaborators

Queen's University

Investigators

Principal Investigator:	Denis E O'Donnell, MD, FRCPC	Queen's University and Kingston General Hospital
Principal Investigator:	Deborah Dudgeon, MD, FRCPC	Queen's University and Kingston General Hospital

More Information

No publications provided

Responsible Party:	Queen's University ( Dr. Denis O'Donnell (Principal Investigator) )
Study ID Numbers:	DSS16327
Study First Received:	September 9, 2009
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00974220 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Queen's University:

inhaled fentanyl
dyspnea
exercise
COPD

Additional relevant MeSH terms:

Anesthetics, Intravenous
Fentanyl
Respiration Disorders
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Adjuvants, Anesthesia
Lung Diseases, Obstructive

Respiratory Tract Diseases
Anesthetics, General
Sensory System Agents
Lung Diseases
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010