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NCT00746330 · ClinicalTrials.gov registry record · Phase 2
Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma
A Phase 2 study, sponsored by Novartis.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT00746330 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 32 participants.
The verdict
NCT00746330, a Phase 2 study, has completed, sponsored by Novartis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and duration of action), of a single dose of formoterol fumarate in combination with mometasone furoate to placebo in children of 5-11 years with persistent asthma. The study will also assess the bronchodilatory effect of a single dose of formoterol fumarate alone and in combination with mometasone furoate delivered via a pressurized metered dose inhaler (pMDI) to the bronchodilatory effect of formoterol fumarate delivered via a dry powder inhaler (DPI). Furthermore, pharmacokinetic assessments of plasma and urine will also be conducted throughout the study to assess systemic exposure following administration of the study medication.
Interventions
- DRUG Mometasone furoate/formoterol fumarate (MFF)
- DRUG Formoterol fumarate 12 μg pMDI (F12M)
- DRUG Formoterol fumarate 12 μg DPI (F12D)
- DRUG Placebo to F12D
- DRUG Placebo to F12M/MFF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00746330
The ClinicalTrials.gov registry entry for NCT00746330 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Mometasone furoate/formoterol fumarate (MFF) is the first listed.
NCT00746330 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00746330 about?
NCT00746330 is a clinical study titled "Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma". This study is being conducted to compare the pharmacodynamics (bronchodilation, onset and duration of action), of a single dose of formoterol fumarate in combination with mometasone furoate to placebo in children of 5-11 years with persistent asthma. The study will also assess the bronchodilatory ef...
What is the current status of trial NCT00746330?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2008-08. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00746330?
The interventions under investigation include: Mometasone furoate/formoterol fumarate (MFF) (DRUG), Formoterol fumarate 12 μg pMDI (F12M) (DRUG), Formoterol fumarate 12 μg DPI (F12D) (DRUG), Placebo to F12D (DRUG), Placebo to F12M/MFF (DRUG).
Who is sponsoring clinical trial NCT00746330?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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