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NCT01097694 · ClinicalTrials.gov registry record · Phase 2

Effects of cKit Inhibition by Imatinib in Patients With Severe Refractory Asthma (KIA)

A Phase 2 study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
Phase 2
Development phase
176
Enrollment target

NCT01097694: Completed Phase 2 study, sponsored by Brigham and Women's Hospital.

NCT01097694 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 176 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01097694, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
Phase 2
Development phase
176 participants
Enrollment target

Study Summary

The purpose of this study is to see whether a new investigational drug (Imatinib) may help improve asthma in people whose symptoms are not well controlled with high dose inhaled corticosteroid treatment.

Primary Outcome

Our primary outcome was change in airway hyperresponsiveness, as assessed by PC20, from baseline to 3 and/or 6 months of therapy in imatinib treated participants as compared with controls. Change in PC20 was assessed using log2-transformed ratios of PC20 at month 3 and /or month 6 vs PC20 at baseline. Our null hypothesis was that the mean of this ratio will be 0 after log2-transformed. We used a linear mixed-effects model for a repeated-measures analysis to compare the primary outcome between th

Interventions

  • DRUG Placebo
  • DRUG Imatinib mesylate

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2010-11
Est. Completion 2016-08
Phase Phase 2
Brigham and Women's Hospital

937 total trials

What the finished NCT01097694 record still lists

NCT01097694 is an interventional study that assigns participants to a tested intervention. The registered 176 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 (32% higher).

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

NCT01097694 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01097694 about?

NCT01097694 is a clinical study titled "Effects of cKit Inhibition by Imatinib in Patients With Severe Refractory Asthma (KIA)". The purpose of this study is to see whether a new investigational drug (Imatinib) may help improve asthma in people whose symptoms are not well controlled with high dose inhaled corticosteroid treatment.

What is the current status of trial NCT01097694?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 176 participants. The study started on 2010-11. Estimated completion is 2016-08.

What interventions are being tested in trial NCT01097694?

The interventions under investigation include: Placebo (DRUG), Imatinib mesylate (DRUG).

Who is sponsoring clinical trial NCT01097694?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01097694's enrollment target sits among peer trials

176 394th of 2000 higher than 1,605 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 NCT01097694, the US trial registry maintained by the National Library of Medicine. NCT01097694 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.