A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Early Head Start program serves lower socioeconomic inner-city children from birth to 3 years. This population has a higher incidence of asthma due to increased exposures. The primary objective of this study is:

To evaluate the effect of early identification of these high risk, inner-city asthmatic infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of health care resources (unscheduled clinic visits, emergency room visits and hospitalizations).

To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to Itsea if indicated.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inhaled Steroid Treatment as Regular Therapy in Early Asthma

NCT00641914

Asthma

COMPLETED PHASE4

Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma

NCT00232648

Asthma

COMPLETED PHASE3

Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma

NCT00509028

Asthma

COMPLETED PHASE3

Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma

NCT00504062

Asthma

COMPLETED PHASE3

PreAsthmaControl (PAC)

NCT00234390

Asthma

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Budesonide respules

Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Pulmicort respules

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children 12-36 months of age with a history of wheezing or airway reactivity responding to bronchodilators, or diagnosed with asthma by a physician.