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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Inhaled Nebulized Fentanyl on Exertional Dyspnea and Exercise Tolerance in Patients With Moderate-to-severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974220
• Other study ID #: DSS16327
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2019
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• fentanyl
single dose, 50 mcg of nebulized fentanyl citrate
• normal saline (placebo)
single dose, 0.9% saline solution

Locations

Country	Name	City	State
Canada	Respiratory Investigation Unit, Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10-minutes post-treatment
Secondary	Cycle Exercise Endurance Time	Constant workrate cycle endurance during tests at 75% of the peak incremental workrate	10-minutes post-treatment