Chronic Obstructive Pulmonary DiseaseNCT00974220

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

A study testing fentanyl in people with Chronic Obstructive Pulmonary Disease, run by Queen's University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: fentanyl
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: 1 siteCanada
Study dates: Jan 2010to Dec 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

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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 locations and contacts

1 site in 1 country.

Canada1 site

Respiratory Investigation Unit, Kingston General Hospital
Kingston, Ontario, K7L 2V7

Other trials in Canada

About this study

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

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
Being tested: fentanyl, normal saline (placebo)
Keywords: inhaled fentanyl, dyspnea, exercise, COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Dyspnea, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00974220
Study group	Role	What they receive
placebo	Placebo comparator	nebulized 0.9% saline placebo Receives: Drug: normal saline (placebo)
fentanyl	Experimental	nebulized fentanyl citrate (50 mcg) Receives: Drug: fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 10-minutes post-treatment

Secondary outcomes (1)

Cycle Exercise Endurance Time
Constant workrate cycle endurance during tests at 75% of the peak incremental workrate
Measured: 10-minutes post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Dec 2010

First posted10 Sep 2009 (estimated)
Study startJan 2010
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00974220
Sponsor's protocol ID: DSS16327
Status last verified: Jul 2019
First submitted: 9 Sep 2009
Last updated: 12 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Inhaled Nebulized Fentanyl on Exertional Dyspnea and Exercise Tolerance in Patients With Moderate-to-severe COPD
ClinicalTrials.gov ID: NCT00974220
Acronym / sponsor ID: DSS16327
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: inhaled fentanyl, dyspnea, exercise, COPD
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Queen's UniversityUniversity, hospital or other
Study start: Jan 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 10 Sep 2009 (estimated)
Results: Posted 30 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
placebo	Placebo comparator	Drug: normal saline (placebo)nebulized 0.9% saline placebo
fentanyl	Experimental	Drug: fentanylnebulized fentanyl citrate (50 mcg)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fentanylsingle dose, 50 mcg of nebulized fentanyl citrate	Drug	fentanyl
normal saline (placebo)single dose, 0.9% saline solution	Drug	placebo

Primary outcome

Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise
Time frame: 10-minutes post-treatment
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.

1 secondary outcome

Cycle Exercise Endurance Time
Time frame: 10-minutes post-treatment

Results and safety

Results posted to the registry on 30 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo - Fentanyl (Order)	9	7
Fentanyl - Placebo (Order)	7	5

Primary outcome: Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise

Time frame: 10-minutes post-treatment. Mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 12	Fentanyl n = 12
Value	2.6 (0.5)	2.0 (0.5)

Population analysed: Subjects who completed both treatment arms of the crossover study were included in the primary analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During visit, with appropriate follow-up to resolution of adverse event. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	2 of 16 (12.5%)	Not reported
Fentanyl	0 of 16 (0%)	1 of 16 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Denis E O'Donnell, MD, FRCPC principal investigator

Queen's University and Kingston General Hospital

Deborah Dudgeon, MD, FRCPC principal investigator

Queen's University and Kingston General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fentanyl in people with Chronic Obstructive Pulmonary Disease, run by Queen's University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dyspnea Intensity Measured by the 10-point Borg Scale During Cycle Exercise (time frame: 10-minutes post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00974220.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.