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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 January 2016 |
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Main ID: |
NCT02108743 |
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Date of registration:
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07/04/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension
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Scientific title:
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Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02108743 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Matthew Lammi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Louisiana State University Health Sciences Center in New Orleans |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years of age or greater.
- Idiopathic Pulmonary Arterial Hypertension, or Familial Pulmonary Arterial
Hypertension.
- Forced expiratory flow 75% (FEF75%) of = 65% of predicted.
Exclusion Criteria:
- 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.
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Idiopathic Pulmonary Arterial Hypertension.
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Intervention(s)
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Drug: Albuterol.
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Drug: Normal saline placebo
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Primary Outcome(s)
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End-expiratory lung volume:total lung capacity (EELV/TLC) ratio at matched metabolic isowork.
[Time Frame: up to 3 days]
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Secondary Outcome(s)
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Change in O2 pulse with albuterol.
[Time Frame: Study days 2 and 3]
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Change in peak oxygen consumption with albuterol
[Time Frame: Study days 2 and 3]
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Borg dyspnea score
[Time Frame: Days 2 and 3]
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Exercise time
[Time Frame: Study days 2 and 3]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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