Pulmonary HypertensionPhase 2NCT03270332
Effect of Inhaled Albuterol in Pulmonary Hypertension
A Phase 2 study testing Albuterol in people with Pulmonary Hypertension, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Albuterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2017to 2 Jul 2020
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A Mean Pulmonary Artery Pressure >25mmHg, Pulmonary Vascular Resistance >3 wood/units and pulmonary arterial wedge pressure <15mmHg, as documented by right heart catheterization within the last 3 years
- Regular use of oral pulmonary vasodilators
Who cannot join
- Presence of chronic respiratory disease (as documented by prior lung imaging and pulmonary function tests), cardiovascular disease (as documented by prior echocardiography and/or left heart catheterization), thromboembolic PAH (as documented by pulmonary angiography)
- women of childbearing potential who do not use accepted birth- control measures
- pregnant and breast-feeding women
- respiratory infection within 4 weeks of testing
- A systemic systolic arterial BP> 150 and/or diastolic arterial BP>100 on the experiment day
- A resting O2 saturation of < 90%
Show all 9Show fewer
- Current smoking
- BMI >35 kg/m2 and/or a diagnosis of obstructive sleep apnea
- Use of inhaled or intravenous pulmonary vasodilators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study
The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation.
- Conditions
- Pulmonary Hypertension
- Being tested
- Albuterol, Placebo
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbuterolDrug
inhalation of 270μg albuterol through a spacer
PlaceboDrug
inhalation of placebo through a spacer
| Study group | Role | What they receive |
|---|---|---|
| Albuterol followed by placebo | Experimental | Participants in this group will receive albuterol first followed by Placebo on the next visit Receives: Drug: Albuterol; Drug: Placebo |
| Placebo followed by albuterol | Experimental | Participants in this group will receive placebo first followed by albuterol on the next visit Receives: Drug: Albuterol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Pulmonary Artery Pressure (MPAP)
Change in MPAP will be measured using echocardiogram
Measured: Baseline, up to 30 minutes after inhalation
Secondary outcomes (1)
Change in Pulmonary Vascular Resistance (PVR)
Change in PVR will be measured using echocardiogram
Measured: Baseline, up to 30 minutes after inhalation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start5 Oct 2017
- Primary completion2 Jul 2020
- Study completion2 Jul 2020
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 Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Wanner, University of Miami
- Investigators
- Adam Wanner, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270332
- Sponsor's protocol ID
- 20170552
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2017
- Last updated
- 30 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03270332
- Acronym / sponsor ID
- 20170552
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Posted 30 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present pilot study is to test the hypothesis that in patients with group 1 pulmonary arterial hypertension (PAH) who are on regular oral pulmonary vasodilator therapy, inhaled albuterol causes transient pulmonary vasodilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albuterol followed by placebo | Experimental | Drug: Albuterol, Drug: PlaceboParticipants in this group will receive albuterol first followed by Placebo on the next visit |
| Placebo followed by albuterol | Experimental | Drug: Albuterol, Drug: PlaceboParticipants in this group will receive placebo first followed by albuterol on the next visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A Mean Pulmonary Artery Pressure >25mmHg, Pulmonary Vascular Resistance >3 wood/units and pulmonary arterial wedge pressure <15mmHg, as documented by right heart catheterization within the last 3 years
- Regular use of oral pulmonary vasodilators
Key exclusion criteria (9 listed)
- Presence of chronic respiratory disease (as documented by prior lung imaging and pulmonary function tests), cardiovascular disease (as documented by prior echocardiography and/or left heart catheterization), thromboembolic PAH (as documented by pulmonary angiography)
- women of childbearing potential who do not use accepted birth- control measures
- pregnant and breast-feeding women
- respiratory infection within 4 weeks of testing
- A systemic systolic arterial BP> 150 and/or diastolic arterial BP>100 on the experiment day
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 |
|---|---|---|
| Albuterolinhalation of 270μg albuterol through a spacer | Drug | Albuterol followed by placebo, Placebo followed by albuterol |
| Placeboinhalation of placebo through a spacer | Drug | Albuterol followed by placebo, Placebo followed by albuterol |
Primary outcome
Change in Mean Pulmonary Artery Pressure (MPAP)
Time frame: Baseline, up to 30 minutes after inhalation
Change in MPAP will be measured using echocardiogram
1 secondary outcome
Change in Pulmonary Vascular Resistance (PVR)
Time frame: Baseline, up to 30 minutes after inhalation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Adam Wanner, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albuterol in people with Pulmonary Hypertension, run by University of Miami at 1 site in United States.
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 2 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 30 Aug 2021. 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 United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2021). 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?
Change in Mean Pulmonary Artery Pressure (MPAP) (time frame: Baseline, up to 30 minutes after inhalation). 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 30 Aug 2021.