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NCT00395304 · ClinicalTrials.gov registry record · Phase 3
Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)
A Phase 3 study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 182
- Enrollment target
NCT00395304: Completed Phase 3 study, sponsored by Milton S. Hershey Medical Center.
NCT00395304 is a Phase 3 study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 182 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00395304, a Phase 3 study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 182 participants
- Enrollment target
Study Summary
Asthma is a common, serious illness among children in the United States. While a low dose of inhaled corticosteroids (ICS) may effectively control symptoms, some children may require additional medications to maintain adequate asthma control. This study compares the effectiveness of a higher dose of ICS, ICS combined with a long-acting beta-agonist (LABA) medication, and ICS combined with a leukotriene receptor antagonist (LTRA) medication at reducing the impact and severity of asthma exacerbations that occur in children with mild to moderate persistent asthma.
Primary Outcome
One treatment period was ranked as better than another if the total amount of prednisone received during the period was at least 180 mg less, if the number of annualized asthma-control days during the final 12 weeks of the period was increased by at least 31 days, or if the FEV1 at the end of the period was at least 5% higher. If the prednisone threshold was met, then we ignored the number of asthmacontrol days and the FEV1. If the threshold for asthma-control days was met, then we ignored the F
Interventions
- DRUG fluticasone propionate
- DRUG fluticasone propionate + montelukast
- DRUG fluticasone propionate + salmeterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2007-03 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT00395304 record still lists
NCT00395304 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 3 interventions - of which fluticasone propionate is the first listed.
NCT00395304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00395304 about?
NCT00395304 is a clinical study titled "Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)". Asthma is a common, serious illness among children in the United States. While a low dose of inhaled corticosteroids (ICS) may effectively control symptoms, some children may require additional medications to maintain adequate asthma control. This study compares the effectiveness of a higher dose of...
What is the current status of trial NCT00395304?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 182 participants. The study started on 2007-03. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00395304?
The interventions under investigation include: fluticasone propionate (DRUG), fluticasone propionate + montelukast (DRUG), fluticasone propionate + salmeterol (DRUG).
Who is sponsoring clinical trial NCT00395304?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00395304's enrollment target sits among peer trials
182 1421st of 2000 higher than 579 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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