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NCT01136382 · ClinicalTrials.gov registry record · Phase 2

A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo

A Phase 2 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 2
Development phase
304
Enrollment target

NCT01136382: Completed Phase 2 study, sponsored by AstraZeneca.

NCT01136382 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 304 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01136382, a Phase 2 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 2
Development phase
304 participants
Enrollment target

Study Summary

This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years

Primary Outcome

The peak expiratory flow rate is the maximal rate that a person can exhale during a short maximal expiratory effort after a full inspiration. Baseline was calculated using the mean of the data recorded during the last 7 days of the run-in period, and the treatment period average was calculated as the mean of all available data recorded during the entire treatment period.

Interventions

  • DRUG placebo
  • DRUG budesonide

Trial Details

FieldValue
Enrollment Target 304 participants
Start Date 2010-07
Est. Completion 2013-04
Phase Phase 2
AstraZeneca

1,285 total trials

What the finished NCT01136382 record still lists

NCT01136382 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (129% higher).

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT01136382 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01136382 about?

NCT01136382 is a clinical study titled "A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo". This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years

What is the current status of trial NCT01136382?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 304 participants. The study started on 2010-07. Estimated completion is 2013-04.

What interventions are being tested in trial NCT01136382?

The interventions under investigation include: placebo (DRUG), budesonide (DRUG).

Who is sponsoring clinical trial NCT01136382?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01136382's enrollment target sits among peer trials

304 166th of 2000 higher than 1,834 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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Source: ClinicalTrials.gov NCT01136382, the US trial registry maintained by the National Library of Medicine. NCT01136382 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.