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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: Completed Phase 2 study, sponsored by Novartis.
NCT00746330 is a Phase 2 study that has completed, run by Novartis. The registered enrollment target is 32 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
For FEV1 AUC(0-12h) the trapezoidal rule was applied using planned time measurements to calculate the AUC up to and including the last measurement recorded before intake of rescue medication. The AUC was standardized by dividing by the length of time for which measurements of FEV1 were included in the calculation of the AUC thus adjusting for subjects who were unable to complete the measurements during the 12-hour observation period and without inhaling rescue medication. The unit of the AUC was
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 |
What the finished NCT00746330 record still lists
NCT00746330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 5 interventions - of which Mometasone furoate/formoterol fumarate (MFF) is the first listed.
NCT00746330 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00746330's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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