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NCT02635334 · ClinicalTrials.gov registry record · Phase 4
Asthma in the Elderly: The Effect of Montelukast
A Phase 4 study of Asthma, sponsored by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C..
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT02635334: Completed Phase 4 study of Asthma, sponsored by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C..
NCT02635334 is a Phase 4 study of Asthma that has completed, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.. The registered enrollment target is 26 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02635334, a Phase 4 study of Asthma, has completed, sponsored by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C..
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the treatment of asthma in subjects who are 12 month old and older. This study is being done because there has been no placebo controlled study of montelukast focused on this group of patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger asthmatics. The pathophysiology of asthma in the elderly is typically different than in younger patients. This is a double-blind, placebo-controlled, crossover study. Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco products in their lifetime. After a run-in period of one week, the study subjects will take montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa. Primary objectives of this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily symptom scores, the Asthma Control Test and the number of puffs of albuterol, and spirometric values (FEV1). Secondary objectives include studying whether montelukast affects peripheral blood eosinophils counts and serum IgE levels.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Montelukast 10 mg orally
Study Locations (1)
Pennsylvania
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. - Bryn Mawr
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02635334
The ClinicalTrials.gov registry entry for NCT02635334 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (98% lower). The listed sponsor is Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C., which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02635334 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02635334 about?
NCT02635334 is a clinical study titled "Asthma in the Elderly: The Effect of Montelukast". This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the treatment of asthma in subjects who are 12 month old and older. This study is being done because there has been no ...
What is the current status of trial NCT02635334?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2015-11. Estimated completion is 2016-06.
What conditions does trial NCT02635334 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02635334?
The interventions under investigation include: Placebo (OTHER), Montelukast 10 mg orally (DRUG).
Who is sponsoring clinical trial NCT02635334?
This trial is sponsored by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02635334 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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