DyspneaEarly Phase 1NCT01853449
Inhaled Fentanyl Citrate & Dyspnea
A Early Phase 1 study testing Fentanyl Citrate and CWS in people with Dyspnea, run by McGill University at 1 site in Canada.
Trial summary
"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyspnea
- What is being tested?
- Fentanyl Citrate and CWS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Aug 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged 20-40 years
- FEV1 ≥80% predicted
- FEV1/FVC >70%
Who cannot join
- Current or ex-smoker
- Body Mass Index <18.5 or >30 kg/m2
- History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
- Taking doctor prescribed medications
- History of using pain-relieving (opioid) and/or anti-depressant medications in the previous 6 weeks
- Allergy to latex
- Allergy to lidocaine or its "caine" derivatives
Trial locations and contacts
1 site in 1 country.
Canada1 site
Montreal Chest Institute; McGill University Health Center & McGill University
Montreal, Quebec, H2X 2P4
About this study
Official title: Effects of Inhaled Fentanyl Citrate on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction
"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve the perception of dyspnea during strenuous exercise in healthy, young men in the presence of an external thoracic restriction. To this end, the investigators plan compare the effects of inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing with and without external thoracic restriction in healthy, men aged 20-40 years.
- Conditions
- Dyspnea
- Being tested
- Fentanyl Citrate, CWS, Placebo
- Keywords
- Fentanyl Citrate, Opioids, Exercise
- Medical subject headings
- Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl CitrateDrug
CWSOther
Also called chest wall strapping
Chest wall strapping to reduce vital capacity by 20% of its baseline value
PlaceboDrug
0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| CWS+Fentanyl Citrate (250 mcg) | Experimental | Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of nebulized fentanyl citrate (250 mcg) Receives: Drug: Fentanyl Citrate; Other: CWS |
| CWS+0.9% saline placebo | Placebo comparator | Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo Receives: Other: CWS; Drug: Placebo |
| No CWS+Fentanyl Citrate (250 mcg) | Active comparator | No chest wall strapping (unloaded control) + single-dose inhalation of nebulized fentanyl citrate (250 mcg) Receives: Drug: Fentanyl Citrate |
| No CWS+0.9% saline placebo | Placebo comparator | No chest wall strapping (unloaded control) + single-dose inhalation of 0.9% saline placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime
Measured: Participants will be followed until all study visits are completed, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Jensen, Ph.D., McGill University
- Investigators
- Dennis Jensen, Ph.D., Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853449
- Sponsor's protocol ID
- A02-M16-13B Fentanyl
- Status last verified
- Feb 2017
- First submitted
- 7 May 2013
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kotrach HG, Bourbeau J, Jensen D. Does nebulized fentanyl relieve dyspnea during exercise in healthy man? J Appl Physiol (1985). 2015 Jun 1;118(11):1406-14. doi: 10.1152/japplphysiol.01091.2014. Epub 2015 Mar 12.
PubMed 26031762
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inhaled Fentanyl Citrate on Perceived Respiratory Discomfort (Dyspnea) During Exercise in the Presence of External Thoracic Restriction
- ClinicalTrials.gov ID
- NCT01853449
- Acronym / sponsor ID
- A02-M16-13B Fentanyl
- Conditions
- Dyspnea
- Keywords
- Fentanyl Citrate, Opioids, Exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Dyspnea" refers to the awareness of breathing discomfort that is typically experienced during exercise in health and disease. In various participant populations, dyspnea is a predictor of disability and death; and contributes to exercise intolerance and an adverse health-related quality-of-life. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals of disease management. Nevertheless, the effective management of dyspnea and activity-limitation remains an elusive goal for many healthcare providers and current strategies aimed at reversing the underlying chronic disease are only partially successful in this regard. Thus, research aimed at identifying dyspnea-specific medications to complement existing therapies for the management of exertional symptoms is timely and clinically relevant. The purpose of this study is to test the hypothesis that single-dose inhalation of fentanyl citrate (a mu-opioid receptor antagonist) will improve the perception of dyspnea during strenuous exercise in healthy, young men in the presence of an external thoracic restriction. To this end, the investigators plan compare the effects of inhaled 0.9% saline placebo and inhaled fentanyl citrate (250 mcg) on detailed assessments of neural respiratory drive (diaphragm EMG), ventilation, breathing pattern, dynamic operating lung volumes, contractile respiratory muscle function, cardio-metabolic function and dyspnea (sensory intensity and affective responses) during symptom-limited, high-intensity, constant-work-rate cycle exercise testing with and without external thoracic restriction in healthy, men aged 20-40 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CWS+Fentanyl Citrate (250 mcg) | Experimental | Drug: Fentanyl Citrate, Other: CWSChest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of nebulized fentanyl citrate (250 mcg) |
| CWS+0.9% saline placebo | Placebo comparator | Other: CWS, Drug: PlaceboChest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of 0.9% saline placebo |
| No CWS+Fentanyl Citrate (250 mcg) | Active comparator | Drug: Fentanyl CitrateNo chest wall strapping (unloaded control) + single-dose inhalation of nebulized fentanyl citrate (250 mcg) |
| No CWS+0.9% saline placebo | Placebo comparator | Drug: PlaceboNo chest wall strapping (unloaded control) + single-dose inhalation of 0.9% saline placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Aged 20-40 years
- FEV1 ≥80% predicted
- FEV1/FVC >70%
Key exclusion criteria (7 listed)
- Current or ex-smoker
- Body Mass Index <18.5 or >30 kg/m2
- History of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
- Taking doctor prescribed medications
- History of using pain-relieving (opioid) and/or anti-depressant medications in the previous 6 weeks
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 |
|---|---|---|
| Fentanyl Citrate | Drug | CWS+Fentanyl Citrate (250 mcg), No CWS+Fentanyl Citrate (250 mcg) |
| CWSAlso: chest wall strappingChest wall strapping to reduce vital capacity by 20% of its baseline value | Other | CWS+0.9% saline placebo, CWS+Fentanyl Citrate (250 mcg) |
| Placebo0.9% saline | Drug | CWS+0.9% saline placebo, No CWS+0.9% saline placebo |
Primary outcome
Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime
Time frame: Participants will be followed until all study visits are completed, an expected average of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Derived from this study: PubMed 26031762Kotrach HG, Bourbeau J, Jensen D. Does nebulized fentanyl relieve dyspnea during exercise in healthy man? J Appl Physiol (1985). 2015 Jun 1;118(11):1406-14. doi: 10.1152/japplphysiol.01091.2014. Epub 2015 Mar 12.
- Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dennis Jensen, Ph.D. principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fentanyl Citrate and CWS in people with Dyspnea, run by McGill 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 4 inclusion and 7 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 14 Feb 2017. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensory intensity (Borg 0-10 scale) ratings of dyspnea at isotime (time frame: Participants will be followed until all study visits are completed, an expected average of 3 weeks). 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 NCT01853449, which also lists 1 linked publication.
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 14 Feb 2017.