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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Queen's University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00974220
First received: September 9, 2009
Last updated: April 18, 2011
Last verified: April 2011
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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: January 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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: Kathy Webb, M.Sc. 613-549-6666 ext 4950 kw2@queensu.ca

Locations
Canada, Ontario
Respiratory Investigation Unit, Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L 2V7
Principal Investigator: Denis E O'Donnell, MD, FRCPC         
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: Dr. Denis O'Donnell (Principal Investigator), Queen's University
ClinicalTrials.gov Identifier: NCT00974220     History of Changes
Other Study ID Numbers: DSS16327
Study First Received: September 9, 2009
Last Updated: April 18, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
inhaled fentanyl
dyspnea
exercise
COPD

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

ClinicalTrials.gov processed this record on April 17, 2014