Status:
COMPLETED
Effect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Queen's University
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
NA
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. S...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00974220
Start Date
January 1 2010
End Date
December 1 2010
Last Update
July 12 2019
Active Locations (1)
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1
Respiratory Investigation Unit, Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7