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NCT02872597 · ClinicalTrials.gov registry record · Phase 1

Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus

A Phase 1 study, sponsored by University Hospitals Cleveland Medical Center.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT02872597: Completed Phase 1 study, sponsored by University Hospitals Cleveland Medical Center.

NCT02872597 is a Phase 1 study that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02872597, a Phase 1 study, has completed, sponsored by University Hospitals Cleveland Medical Center.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled placebo.

Primary Outcome

In our PICU, status asthmaticus patients are initially treated with continuous nebulization of albuterol. Per a standard assessment/scoring system, the patients are re-assessed each hour. When the patient's symptoms have sufficiently improved, the albuterol is weaned to 2.5mg given every 1hr ("q1hr albuterol") and, subsequently, to 2.5mg given every 2 hours ("q2hr Albuterol"). This outcome will measure the interval between the initiation of continuous albuterol and the second dose of q2hr Albute

Interventions

  • DRUG Albuterol
  • DRUG 0.9% Sodium Chloride
  • DRUG corticosteroids
  • DRUG Ipratropium

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2016-09-05
Est. Completion 2018-08-16
Phase Phase 1

What the finished NCT02872597 record still lists

NCT02872597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 4 interventions - of which Albuterol is the first listed.

NCT02872597 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02872597 about?

NCT02872597 is a clinical study titled "Phase I, Placebo-Controlled, Blinded Pilot Study of Ipratropium in Children Admitted to the ICU With Status Asthmaticus". This study is a Phase I study to investigate the addition of inhaled Ipratropium bromide to standard therapy in the treatment of severe asthma attacks in children admitted to the Pediatric Intensive Care Unit. Half of the subjects will receive inhaled Ipratropium, and half will receive an inhaled pl...

What is the current status of trial NCT02872597?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-09-05. Estimated completion is 2018-08-16.

What interventions are being tested in trial NCT02872597?

The interventions under investigation include: Albuterol (DRUG), 0.9% Sodium Chloride (DRUG), corticosteroids (DRUG), Ipratropium (DRUG).

Who is sponsoring clinical trial NCT02872597?

This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02872597's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02872597, the US trial registry maintained by the National Library of Medicine. NCT02872597 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.