Status:
COMPLETED
Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators
Lead Sponsor:
Dr. Denis O'Donnell
Collaborating Sponsors:
Ontario Lung Association
Queen's University
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-90 years
Phase:
PHASE4
Brief Summary
Activity-related breathlessness (dyspnea) is the dominant symptom and persists despite optimal medical care in as many as 50% of patients with advanced chronic obstructive pulmonary disease (COPD). Th...
Detailed Description
Dyspnea arises during exercise in COPD patients when there is a mismatch between the ventilatory demand (largely dictated by chemical stimuli) and the capacity to respond to that demand (dictated by m...
Eligibility Criteria
Inclusion
- Post-bronchodilator forced expiratory volume in 1 sec (FEV1) 30-79% predicted and FEV1/forced vital capacity (FVC) \<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
- Male or female ≥40 yrs of age
- Cigarette smoking history ≥20 pack-years
- Moderate-to-severe chronic activity-related dyspnea as defined by a modified MRC dyspnea scale ≥2, COPD Assessment Test score ≥10 or Baseline Dyspnea Index focal score ≤6 (47-49)
- Ability to perform all study procedures and provide/sign informed consent.
Exclusion
- Women of childbearing age who are pregnant or trying to become pregnant
- Diffusing capacity of the lung for carbon monoxide (DLCO) value of \<40 %predicted
- Active cardiopulmonary disease other than COPD that could contribute to dyspnea and exercise limitation
- History/clinical evidence of asthma, atopy and/or nasal polyps
- History of hypercapnic respiratory failure or a clinical diagnosis of sleep disordered breathing
- History of allergy or adverse response to fentanyl
- Important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s)
- Use of daytime oxygen or exercise-induced O2 desaturation to \< 80% on room air
- Body mass index (BMI) \<18.5 or ≥35.0 kg/m2
- Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks
- Use of opioid drugs (e.g., morphine, fentanyl, oxycodone, codeine, etc.) in the previous 4 weeks.
Key Trial Info
Start Date :
September 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03405090
Start Date
September 20 2017
End Date
March 31 2023
Last Update
April 3 2024
Active Locations (1)
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1
Respiratory Investigation Unit
Kingston, Ontario, Canada, K7L 2V7