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

Completed · Phase 1 · Has a placebo group

Conditions studied: Status Asthmaticus

In brief

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.

Key facts

Study ID

NCT02872597

Run by

University Hospitals Cleveland Medical Center

People needed

30

Starts

2016-09-05

Expected to finish

2018-08-16

Last updated by the study team

2019-04-18

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admission to the PICU
• Treatment with continuous albuterol via the Asthma Carepath
• Enrollment occurred within 4 hours of starting continuous albuterol in the PICU
• Treatment with systemic corticosteroids by the clinical team

You may not qualify if…

• First episode of wheezing that prompted treatment with bronchodilators by medical personnel
• Prior enrollment in this study
• Patients with chronic lung disease requiring routine home oxygen use
• Allergy to inhaled ipratropium or inhaled saline
• Positive pressure ventilation (via an endotracheal tube or a non-invasive mask [e.g. CPAP (continuous positive airway pressure) or BiPAP])
• Pregnancy
• Tracheostomy
• Age < 2 years
• Age > 17 years
• Patient with pulmonary hypertension requiring daily therapy
• Patient with cyanotic congenital heart disease
• Cystic fibrosis

Where it is running

• Rainbow Babies and Children's Hospital (of Univ. Hospitals Case Med. Center) — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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