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

NCT ID: NCT00974220

Last Updated: 2019-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

nebulized 0.9% saline placebo

Group Type: PLACEBO_COMPARATOR

normal saline (placebo)

Intervention Type: DRUG

single dose, 0.9% saline solution

fentanyl

nebulized fentanyl citrate (50 mcg)

Group Type: EXPERIMENTAL

fentanyl

Intervention Type: DRUG

single dose, 50 mcg of nebulized fentanyl citrate

Interventions

fentanyl

single dose, 50 mcg of nebulized fentanyl citrate

Intervention Type: DRUG

normal saline (placebo)

single dose, 0.9% saline solution

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Denis O'Donnell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denis E O'Donnell, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Deborah Dudgeon, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Queen's University and Kingston General Hospital

Locations

Respiratory Investigation Unit, Kingston General Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DSS16327

Identifier Type: -

Identifier Source: org_study_id