Idiopathic Pulmonary Arterial Hypertension.Phase 2NCT02108743
Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
A Phase 2 study testing Albuterol. in people with Idiopathic Pulmonary Arterial Hypertension., run by American Medical Association Foundation at 1 site in United States.
Trial summary
The purpose of this study is to determine if dynamic hyperinflation seen in patients with idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Idiopathic Pulmonary Arterial Hypertension.
- What is being tested?
- Albuterol.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2016
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or greater.
- Idiopathic Pulmonary Arterial Hypertension, or Familial Pulmonary Arterial Hypertension.
- Forced expiratory flow 75% (FEF75%) of ≤ 65% of predicted.
Who cannot join
- Clinical instability or change in medication therapy in preceding 3 months.
- Allergy or intolerance to inhaled albuterol.
- Body mass index > 30
- Active tobacco use, or > 10 pack-year smoking history.
- Lung disease other than pulmonary hypertension
- Forced expiratory volume in 1 second (FEV1) ≤ 80% of predicted.
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- Pregnancy
- Inability to perform pulmonary function testing.
- Inability to perform cardiopulmonary exercise testing.
- Supplemental oxygen requirement.
- Inability to read and understand English.
- Historical 6-minute walk distance <150 meters
Trial locations and contacts
1 site in 1 country.
United States1 site
LSUHSC Interim Louisiana Hospital
New Orleans, Louisiana, 70112
About this study
The purpose of this study is to determine if dynamic hyperinflation seen in patients with idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy.
Read the detailed description
Only a few small studies have evaluated the relationship between iPAH, expiratory flow limitation, and exercise dyspnea. While not all patients with iPAH demonstrate airway involvement, those who demonstrate dynamic hyperinflation (DH), defined as a variable and temporary increase in end-expiratory lung volume, report increased dyspnea with exertion on maximal testing. There is a continued need for adjuvant therapy in iPAH, and bronchodilators have the potential to ameliorate dyspnea during exercise, which could lead to improved quality of life in this disabling condition. This study will investigate the presence of airway involvement in this population as measured by dynamic hyperinflation, and if there is any improvement in function with the use of inhaled albuterol.
- Being tested
- Albuterol., Normal saline placebo
- Medical subject headings
- Familial Primary Pulmonary Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol.Drug
2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
Normal saline placeboDrug
Placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
| Study group | Role | What they receive |
|---|---|---|
| Albuterol | Active comparator | 2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET. Receives: Drug: Albuterol. |
| Placebo | Placebo comparator | Normal saline placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET. Receives: Drug: Normal saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.
Determined by measuring inspiratory capacity every 2 minutes during cardiopulmonary exercise test (CPET)
Measured: up to 3 days
Secondary outcomes (4)
Change in peak oxygen consumption with albuterol
Measured at the end of CPET
Measured: Study days 2 and 3
Change in O2 pulse with albuterol.
Measured throughout CPET and compared at matched metabolic isotimes
Measured: Study days 2 and 3
Exercise time
Total ramped exercise time
Measured: Study days 2 and 3
Borg dyspnea score
Measured every 2 minutes throughout CPET
Measured: Days 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2016 (estimated)
- Study completionOct 2016 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary Arterial Hypertension.Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Medical Association Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Matthew Lammi, MD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108743
- Sponsor's protocol ID
- IRB8603
- Status last verified
- Dec 2015
- First submitted
- 7 Apr 2014
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meyer FJ, Ewert R, Hoeper MM, Olschewski H, Behr J, Winkler J, Wilkens H, Breuer C, Kubler W, Borst MM; German PPH Study Group. Peripheral airway obstruction in primary pulmonary hypertension. Thorax. 2002 Jun;57(6):473-6. doi: 10.1136/thorax.57.6.473.
PubMed 12037220Fernandez-Bonetti P, Lupi-Herrera E, Martinez-Guerra ML, Barrios R, Seoane M, Sandoval J. Peripheral airways obstruction in idiopathic pulmonary artery hypertension (primary). Chest. 1983 May;83(5):732-8. doi: 10.1378/chest.83.5.732.
PubMed 6839814Laveneziana P, Garcia G, Joureau B, Nicolas-Jilwan F, Brahimi T, Laviolette L, Sitbon O, Simonneau G, Humbert M, Similowski T. Dynamic respiratory mechanics and exertional dyspnoea in pulmonary arterial hypertension. Eur Respir J. 2013 Mar;41(3):578-87. doi: 10.1183/09031936.00223611. Epub 2012 Jul 12.
PubMed 22790921Spiekerkoetter E, Fabel H, Hoeper MM. Effects of inhaled salbutamol in primary pulmonary hypertension. Eur Respir J. 2002 Sep;20(3):524-8. doi: 10.1183/09031936.02.02572001.
PubMed 12358324
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02108743
- Acronym / sponsor ID
- IRB8603
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American Medical Association FoundationUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 9 Apr 2014 (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.
The purpose of this study is to determine if dynamic hyperinflation seen in patients with idiopathic pulmonary artery hypertension (iPAH) improves with albuterol therapy.
Detailed description
Only a few small studies have evaluated the relationship between iPAH, expiratory flow limitation, and exercise dyspnea. While not all patients with iPAH demonstrate airway involvement, those who demonstrate dynamic hyperinflation (DH), defined as a variable and temporary increase in end-expiratory lung volume, report increased dyspnea with exertion on maximal testing. There is a continued need for adjuvant therapy in iPAH, and bronchodilators have the potential to ameliorate dyspnea during exercise, which could lead to improved quality of life in this disabling condition. This study will investigate the presence of airway involvement in this population as measured by dynamic hyperinflation, and if there is any improvement in function with the use of inhaled albuterol.
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 |
|---|---|---|
| Albuterol | Active comparator | Drug: Albuterol.2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET. |
| Placebo | Placebo comparator | Drug: Normal saline placeboNormal saline placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or greater.
- Idiopathic Pulmonary Arterial Hypertension, or Familial Pulmonary Arterial Hypertension.
- Forced expiratory flow 75% (FEF75%) of ≤ 65% of predicted.
Key exclusion criteria (12 listed)
- Clinical instability or change in medication therapy in preceding 3 months.
- Allergy or intolerance to inhaled albuterol.
- Body mass index > 30
- Active tobacco use, or > 10 pack-year smoking history.
- Lung disease other than pulmonary hypertension
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 |
|---|---|---|
| Albuterol.2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET. | Drug | Albuterol |
| Normal saline placeboPlacebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET. | Drug | Placebo |
Primary outcome
End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.
Time frame: up to 3 days
Determined by measuring inspiratory capacity every 2 minutes during cardiopulmonary exercise test (CPET)
4 secondary outcomes
Change in peak oxygen consumption with albuterol
Time frame: Study days 2 and 3
Change in O2 pulse with albuterol.
Time frame: Study days 2 and 3
Exercise time
Time frame: Study days 2 and 3
Borg dyspnea score
Time frame: Days 2 and 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Background: PubMed 12037220Meyer FJ, Ewert R, Hoeper MM, Olschewski H, Behr J, Winkler J, Wilkens H, Breuer C, Kubler W, Borst MM; German PPH Study Group. Peripheral airway obstruction in primary pulmonary hypertension. Thorax. 2002 Jun;57(6):473-6. doi: 10.1136/thorax.57.6.473.
- Background: PubMed 6839814Fernandez-Bonetti P, Lupi-Herrera E, Martinez-Guerra ML, Barrios R, Seoane M, Sandoval J. Peripheral airways obstruction in idiopathic pulmonary artery hypertension (primary). Chest. 1983 May;83(5):732-8. doi: 10.1378/chest.83.5.732.
- Background: PubMed 22790921Laveneziana P, Garcia G, Joureau B, Nicolas-Jilwan F, Brahimi T, Laviolette L, Sitbon O, Simonneau G, Humbert M, Similowski T. Dynamic respiratory mechanics and exertional dyspnoea in pulmonary arterial hypertension. Eur Respir J. 2013 Mar;41(3):578-87. doi: 10.1183/09031936.00223611. Epub 2012 Jul 12.
- Background: PubMed 12358324Spiekerkoetter E, Fabel H, Hoeper MM. Effects of inhaled salbutamol in primary pulmonary hypertension. Eur Respir J. 2002 Sep;20(3):524-8. doi: 10.1183/09031936.02.02572001.
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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.
Matthew Lammi, MD principal investigator
Louisiana State University Health Sciences Center in New Orleans
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 Idiopathic Pulmonary Arterial Hypertension., run by American Medical Association Foundation 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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 30 Dec 2015. 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. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork. (time frame: up to 3 days). 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 NCT02108743, which also lists 4 linked publications.
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 Dec 2015.