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

Q

Queen's University

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: normal saline (placebo)
Drug: fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT00974220
DSS16327

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

16 participants in 2 patient groups, including a placebo group

placebo
Placebo Comparator group
Description:
nebulized 0.9% saline placebo
Treatment:
Drug: normal saline (placebo)
fentanyl
Experimental group
Description:
nebulized fentanyl citrate (50 mcg)
Treatment:
Drug: fentanyl

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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