Clinical trial NCT00974220: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: inhaled fentanyl
dyspnea
exercise
COPD
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise
timeFrame: 10-minutes post-treatment
Secondary outcomes:
measure: Cycle Exercise Endurance Time
timeFrame: 10-minutes post-treatment
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Respiratory Investigation Unit, Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University and Kingston General Hospital
name: Denis E O'Donnell, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University and Kingston General Hospital
name: Deborah Dudgeon, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: