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NCT01136655 · ClinicalTrials.gov registry record · Phase 2
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
NCT01136655: Completed Phase 2 study, sponsored by AstraZeneca.
NCT01136655 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 54 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136655, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
Study Summary
This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.
Primary Outcome
Pulmonary function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 was obtained from the full expiratory flow-volume-time curve. FEV1 was measured at 3, 9, 15, 60, 120, 180, 240, 360, 480, 600 and 720 minutes post administration of randomized study medication. Twelve-hour serial FEV1 was calculated through an AUC determination and then divided by time, so that the final value i
Interventions
- DRUG 80/2.25 μg Symbicort pMDI
- DRUG 80/4.5 μg Symbicort pMDI
- DRUG Foradil Aerolizer 12 μg
- DRUG 40 μg budesonide HFA pMDI
- DRUG placebo HFA pMDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2010-09 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT01136655 record still lists
NCT01136655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 5 interventions - of which 80/2.25 μg Symbicort pMDI is the first listed.
NCT01136655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01136655 about?
NCT01136655 is a clinical study titled "A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy". This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.
What is the current status of trial NCT01136655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2010-09. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01136655?
The interventions under investigation include: 80/2.25 μg Symbicort pMDI (DRUG), 80/4.5 μg Symbicort pMDI (DRUG), Foradil Aerolizer 12 μg (DRUG), 40 μg budesonide HFA pMDI (DRUG), placebo HFA pMDI (DRUG).
Who is sponsoring clinical trial NCT01136655?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01136655's enrollment target sits among peer trials
54 1160th of 2000 higher than 830 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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