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NCT01550471 · ClinicalTrials.gov registry record · Phase 4
Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis
A Phase 4 study of Asthma and Allergic Rhinitis, sponsored by West Penn Allegheny Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
- 2
- Study locations
NCT01550471: Completed Phase 4 study of Asthma and Allergic Rhinitis, sponsored by West Penn Allegheny Health System.
NCT01550471 is a Phase 4 study of Asthma and Allergic Rhinitis that has completed, run by West Penn Allegheny Health System. The registered enrollment target is 22 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01550471, a Phase 4 study of Asthma and Allergic Rhinitis, has completed, sponsored by West Penn Allegheny Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will provide the clinicians guidance on the safest combination of inhaled and nasal corticosteroids for children with mild asthma and allergic rhinitis respectively; however, one safety concern is that these products are independently known to have dose-related effects on short term and intermediate term growth. Knemometry is a non invasive technique for measuring short-term lower leg growth in children and is currently the method of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.
Primary Outcome
To evaulate the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID on- short-term lower leg growth as measured by knemometry in children with mild asthma and allergic rhinitis.
Conditions Studied
Interventions
- DRUG Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo
- DRUG Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase
- DRUG QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo
- DRUG QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris
- DRUG Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase
Study Locations (2)
Pennsylvania
- Pediatric Alliance-Greentree Division - Green Tree
- Alleghney General Hospital - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2012-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
What the finished NCT01550471 record still lists
NCT01550471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 5 interventions - of which Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo is the first listed.
NCT01550471 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01550471 about?
NCT01550471 is a clinical study titled "Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis". This study will provide the clinicians guidance on the safest combination of inhaled and nasal corticosteroids for children with mild asthma and allergic rhinitis respectively; however, one safety concern is that these products are independently known to have dose-related effects on short term and i...
What is the current status of trial NCT01550471?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2012-03. Estimated completion is 2015-08.
What conditions does trial NCT01550471 study?
This clinical trial studies the following conditions: Asthma, Allergic Rhinitis.
What interventions are being tested in trial NCT01550471?
The interventions under investigation include: Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo (DRUG), Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase (DRUG), QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo (DRUG), QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris (DRUG), Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase (DRUG).
Who is sponsoring clinical trial NCT01550471?
This trial is sponsored by West Penn Allegheny Health System, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01550471 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01550471's enrollment target sits among peer trials
22 332nd of 374 higher than 39 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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