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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974220
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : December 30, 2015
Last Update Posted : December 30, 2015
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: fentanyl Drug: normal saline (placebo) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Inhaled Nebulized Fentanyl on Exertional Dyspnea and Exercise Tolerance in Patients With Moderate-to-severe COPD
Study Start Date : January 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: placebo
nebulized 0.9% saline placebo
Drug: normal saline (placebo)
single dose, 0.9% saline solution
Experimental: fentanyl
nebulized fentanyl citrate (50 mcg)
Drug: fentanyl
single dose, 50 mcg of nebulized fentanyl citrate

Primary Outcome Measures :
  1. Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise [ Time Frame: 10-minutes post-treatment ]
    The 10-point Borg scale ranges from 0 "nothing at all" to 10 "maximal/extremely strong" and was used to rate the intensity of dyspnea during exercise; therefore, a decrease in this rating signifies an improvement. Dyspnea intensity was assessed at the highest equivalent standardized time achieved in both post-treatment constant work rate cycle exercise tests.

Secondary Outcome Measures :
  1. Cycle Exercise Endurance Time [ Time Frame: 10-minutes post-treatment ]
    Constant workrate cycle endurance during tests at 75% of the peak incremental workrate

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00974220

Canada, Ontario
Respiratory Investigation Unit, Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Sponsors and Collaborators
Queen's University
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

Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University Identifier: NCT00974220     History of Changes
Other Study ID Numbers: DSS16327
First Posted: September 10, 2009    Key Record Dates
Results First Posted: December 30, 2015
Last Update Posted: December 30, 2015
Last Verified: November 2015

Keywords provided by Dr. Denis O'Donnell, Queen's University:
inhaled fentanyl

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General