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

NCT00974220 | Completed Results

• 1 other identifier: DSS16327
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

inhaled fentanyl; dyspnea; exercise; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cycle Exercise Endurance Time

  10-minutes post-treatment

Study Arms (2)

placebo

PLACEBO COMPARATOR

nebulized 0.9% saline placebo

Drug: normal saline (placebo)

fentanyl

EXPERIMENTAL

nebulized fentanyl citrate (50 mcg)

Drug: fentanyl

Interventions

fentanyl DRUG

single dose, 50 mcg of nebulized fentanyl citrate

fentanyl

normal saline (placebo) DRUG

single dose, 0.9% saline solution

placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Respiratory Investigation Unit, Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Motor Activity

Interventions

Fentanyl; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Denis O'Donnell
• Organization: Queen's University, Kingston, ON, Canada

odonnell@queensu.ca

1-613-548-2339

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 10, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 12, 2019
• Results First Posted: December 30, 2015

Record last verified: 2019-07

Locations

CA (1)