BreathlessnessPhase 1NCT01851980
Inhaled Nebulized Furosemide & Physical Activity-Related Breathlessness
A Phase 1 study testing CWS and Furosemide in people with Breathlessness, run by McGill University at 1 site in Canada.
Trial summary
Breathlessness on exertion is a common and troublesome complaint of individuals with restrictive lung disorders. In these adults, breathlessness contributes to physical activity-limitation and avoidance and an adverse health-related quality-of-life, often in a self-perpetuating cycle. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Breathlessness
- What is being tested?
- CWS and Furosemide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Sep 2017
- Phase
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged 18-40 years
- FEV1 ≥80% predicted
- FEV1/FVC >70%
Who cannot join
- Current or ex-smoker
- Body Mass Index <18.5 or >30 kg/m2
- Self-reported history of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
- Taking doctor prescribed medications
- Allergy to sulfa medications
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre of Innovative Medicine of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
Dennis Jensen, Ph.D., 514-398-4184 ext. 0472, dennis.jensen@mcgill.ca
About this study
Official title: Effects of Inhaled Furosemide on Breathlessness During Exercise in the Presence of External Thoracic Restriction: A Dose-Reponse Study
Breathlessness on exertion is a common and troublesome complaint of individuals with restrictive lung disorders. In these adults, breathlessness contributes to physical activity-limitation and avoidance and an adverse health-related quality-of-life, often in a self-perpetuating cycle. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals in the management of adults with restrictive lung disorders. Nevertheless, effective management of breathlessness and physical activity-limitation remains an elusive goal for many healthcare providers and current therapies (e.g., antifibrotic agents, oxygen, exercise training) are only partially successful in this regard. Thus, research aimed at identifying breathlessness-specific medications to complement existing therapies for the management of physical activity-related breathlessness in restrictive lung disorders is timely and both clinically and physiologically relevant. The purpose of this randomized crossover study study is to examine the acute effects of two doses of inhaled nebulized furosemide (a loop diuretic) on the perception of breathlessness during laboratory-based cycle exercise in healthy, young men in the presence of an external thoracic restriction to mimic a 'mild' restrictive lung deficit. To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled furosemide (40 mg and 120 mg) on detailed assessments of breathlessness (sensory intensity and affective responses) and its physiological determinants (ventilation, breathing pattern, dynamic operating lung volumes, cardio-metabolic function) symptom-limited, high-intensity, constant-work-rate cycle exercise testing with external thoracic restriction sufficient to mimic a 'mild' restrictive pulmonary deficit in healthy, men aged 18-40 years.
- Conditions
- Breathlessness
- Being tested
- CWS, Furosemide, Placebo
- Keywords
- Furosemide, Exercise, Restrictive pulmonary disorder
- 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.
CWSOther
Also called Chest wall strapping
Chest wall strapping to reduced vital capacity by 20% of its baseline value
FurosemideDrug
40 mg and 120 mg
PlaceboDrug
0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| CWS+Furosemide (40 mg) | Experimental | Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of furosemide (40 mg) Receives: Other: CWS; Drug: Furosemide |
| 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 |
| CWS+Furosemide (120 mg) | Experimental | Chest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of furosemide (120 mg) Receives: Other: CWS; Drug: Furosemide |
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 posted13 May 2013 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreathlessnessStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
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
- NCT01851980
- Sponsor's protocol ID
- 15-370-MUHC
- 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
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 Furosemide on Breathlessness During Exercise in the Presence of External Thoracic Restriction: A Dose-Reponse Study
- ClinicalTrials.gov ID
- NCT01851980
- Acronym / sponsor ID
- 15-370-MUHC
- Conditions
- Breathlessness
- Keywords
- Furosemide, Exercise, Restrictive pulmonary disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 13 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.
Breathlessness on exertion is a common and troublesome complaint of individuals with restrictive lung disorders. In these adults, breathlessness contributes to physical activity-limitation and avoidance and an adverse health-related quality-of-life, often in a self-perpetuating cycle. It follows that alleviating dyspnea and improving exercise tolerance are among the principal goals in the management of adults with restrictive lung disorders. Nevertheless, effective management of breathlessness and physical activity-limitation remains an elusive goal for many healthcare providers and current therapies (e.g., antifibrotic agents, oxygen, exercise training) are only partially successful in this regard. Thus, research aimed at identifying breathlessness-specific medications to complement existing therapies for the management of physical activity-related breathlessness in restrictive lung disorders is timely and both clinically and physiologically relevant. The purpose of this randomized crossover study study is to examine the acute effects of two doses of inhaled nebulized furosemide (a loop diuretic) on the perception of breathlessness during laboratory-based cycle exercise in healthy, young men in the presence of an external thoracic restriction to mimic a 'mild' restrictive lung deficit. To this end, the investigators will compare the effects of inhaled 0.9% saline placebo and inhaled furosemide (40 mg and 120 mg) on detailed assessments of breathlessness (sensory intensity and affective responses) and its physiological determinants (ventilation, breathing pattern, dynamic operating lung volumes, cardio-metabolic function) symptom-limited, high-intensity, constant-work-rate cycle exercise testing with external thoracic restriction sufficient to mimic a 'mild' restrictive pulmonary deficit in healthy, men aged 18-40 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CWS+Furosemide (40 mg) | Experimental | Other: CWS, Drug: FurosemideChest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of furosemide (40 mg) |
| 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 |
| CWS+Furosemide (120 mg) | Experimental | Other: CWS, Drug: FurosemideChest wall strapping to reduce vital capacity by 20% of its baseline value + single-dose inhalation of furosemide (120 mg) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Aged 18-40 years
- FEV1 ≥80% predicted
- FEV1/FVC >70%
Key exclusion criteria (5 listed)
- Current or ex-smoker
- Body Mass Index <18.5 or >30 kg/m2
- Self-reported history of cardiovascular, vascular, respiratory, renal, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
- Taking doctor prescribed medications
- Allergy to sulfa medications
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 |
|---|---|---|
| CWSAlso: Chest wall strappingChest wall strapping to reduced vital capacity by 20% of its baseline value | Other | CWS+0.9% saline placebo, CWS+Furosemide (120 mg), CWS+Furosemide (40 mg) |
| Furosemide40 mg and 120 mg | Drug | CWS+Furosemide (120 mg), CWS+Furosemide (40 mg) |
| Placebo0.9% saline | Drug | 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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- 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 Phase 1 study testing CWS and Furosemide in people with Breathlessness, 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 5 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: status not confirmed, 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis Jensen, Ph.D. (514-398-4184 ext. 0472, dennis.jensen@mcgill.ca), or a site near the patient. 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?
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.