Back to resultsEffect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
fentanyl
normal saline (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring inhaled fentanyl, dyspnea, exercise, COPD
Eligibility 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.
Sites / Locations
- Respiratory Investigation Unit, Kingston General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
placebo
fentanyl
Arm Description
nebulized 0.9% saline placebo
nebulized fentanyl citrate (50 mcg)
Outcomes
Primary Outcome Measures
Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise
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
Cycle Exercise Endurance Time
Constant workrate cycle endurance during tests at 75% of the peak incremental workrate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00974220
Brief Title
Effect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Effect of Inhaled Nebulized Fentanyl on Exertional Dyspnea and Exercise Tolerance in Patients With Moderate-to-severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
inhaled fentanyl, dyspnea, exercise, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
nebulized 0.9% saline placebo
Arm Title
fentanyl
Arm Type
Experimental
Arm Description
nebulized fentanyl citrate (50 mcg)
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
single dose, 50 mcg of nebulized fentanyl citrate
Intervention Type
Drug
Intervention Name(s)
normal saline (placebo)
Intervention Description
single dose, 0.9% saline solution
Primary Outcome Measure Information:
Title
Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise
Description
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.
Time Frame
10-minutes post-treatment
Secondary Outcome Measure Information:
Title
Cycle Exercise Endurance Time
Description
Constant workrate cycle endurance during tests at 75% of the peak incremental workrate
Time Frame
10-minutes post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis E O'Donnell, MD, FRCPC
Organizational Affiliation
Queen's University and Kingston General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah Dudgeon, MD, FRCPC
Organizational Affiliation
Queen's University and Kingston General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory Investigation Unit, Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
12. IPD Sharing Statement
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Effect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)
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