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NCT01070888 · ClinicalTrials.gov registry record · Phase 4

Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma

A Phase 4 study, sponsored by Boston Children's Hospital.

Terminated
Registry status
Phase 4
Development phase
6
Enrollment target

NCT01070888: Clinical Trial Phase 4 study, sponsored by Boston Children's Hospital.

NCT01070888 is a Phase 4 study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01070888, a Phase 4 study, was terminated before completion, sponsored by Boston Children's Hospital.

TERMINATED
Registry status
Phase 4
Development phase
6 participants
Enrollment target

Study Summary

The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma. The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

Primary Outcome

Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows: (max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))

Interventions

  • DRUG Budesonide/Formoterol
  • DRUG Budesonide

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2010-02
Est. Completion 2014-04
Phase Phase 4
Boston Children's Hospital

462 total trials

Why NCT01070888 stopped before completion

NCT01070888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).

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

NCT01070888 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01070888 about?

NCT01070888 is a clinical study titled "Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma". The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma. The investigators hypothesize that in children and adults who suffer from asthma and exercise induced ...

What is the current status of trial NCT01070888?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2010-02. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01070888?

The interventions under investigation include: Budesonide/Formoterol (DRUG), Budesonide (DRUG).

Who is sponsoring clinical trial NCT01070888?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01070888's enrollment target sits among peer trials

6 1983rd of 2000 higher than 12 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT01070888, the US trial registry maintained by the National Library of Medicine. NCT01070888 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.