Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

March 15, 2010 updated by: Abbott Nutrition

Effect of Novel Medical Food on Reducing the Frequency and Severity of Asthma Symptoms and Airway Hyper-responsiveness in Children With Mild to Moderate Persistent Asthma

To determine the effect of medical food on reducing asthma symptoms in asthmatic children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female children who have had mild to moderate persistent asthma for at least 1 year and are between 6 and 14 years of age, and not currently being treated with steroids are eligible.

Each subject also has to have:

  • Subject is off of controller therapy 4 wks preceding visit 1.
  • Mild to moderate persistent asthma
  • Methacholine responsiveness with an FEV1 PC20
  • Able to perform reproducible spirometry
  • Verbal assent in addition to consent
  • History of prior clinical varicella or varicella vaccine.
  • Nonsmoker in past year.

Exclusion Criteria:

  • Asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period.
  • Subject with FEV1 < 80% predicted at visit 1 or FEV1 < 70% predicted at visit 2.
  • Two or more hospitalizations for asthma in the past year.
  • Subject has received oral, nasal, inhaled, or IM corticosteroids during the preceding month.
  • Subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1

  • Subject is receiving one or more of the following medications:

    • Astemizole prior to 3 months of visit 1
    • Oral, inhaled or parenteral corticosteroids prior to 4 weeks of visit 1
    • Cromolyn, antimuscarinics, cimetidine, metoclopramide, phenobarbital, phenytion, terfenadine, loratadine, or anticholingeric agents prior to 2 weeks of visit 1.
    • Theophylline prior to 4 weeks of visit 1
  • Subject with active upper respiratory tract infection prior to 4 weeks before visit 1
  • Subject with acute sinus disease requiring antibiotic treatment within 1 week before visit
  • Subject with an emergency department treatment for asthma within 1 month, prior intubation for asthma, or hospitalization for asthma within 3 months
  • Subject has known bleeding disorder and/or is on medication known to have significant anticoagulant effects.
  • Subject has known hypersensitivity to any of the ingredients
  • Subject is taking either pill, powder, or liquid forms of nutritional and/or health food supplements within the past 4 weeks prior to visit
  • Subject unable to tolerate or unwilling to take the full dose of the nutritional study formulas
  • Cystic fibrosis or any other chronic lung disease other than asthma.
  • Subject having gastroesophogeal reflux undergoing medical treatment
  • Significant medical illness other than asthma that could require oral corticosteroids during the study.
  • Subject is receiving allergen hyposensitization therapy other than an established maintenance regimen
  • Subject has received IV globulins or immunosuppressants.
  • Subject is known to be human immunodeficiency virus (HIV) positive.
  • Pregnancy or lactation.
  • If of child bearing potential, failure to practice abstinence or use of an acceptable birth control method.
  • Subject is morbidly obese

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: novel nutritional formula
Other: medical food with EPA and GLA, vitamins and minerals
1 8oz serving per day for 12 weeks
Active Comparator: Control nutritional product
1 8oz serving per day for 12 weeks
Other: medical food minus EPA and GLA, antioxidant vitamins/minerals
1 8oz serving a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
asthma free days
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
reduction of airway hyper-responsiveness
Time Frame: 12 weeks
12 weeks
time to the first asthma exacerbation
Time Frame: 12 weeks
12 weeks
respiratory function (spirometry)
Time Frame: 12 weeks
12 weeks
need for rescue for exacerbations of asthma symptoms.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Stehen DeMichele, PhD, Abbott Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 15, 2010

First Posted (Estimate)

March 16, 2010

Study Record Updates

Last Update Posted (Estimate)

March 16, 2010

Last Update Submitted That Met QC Criteria

March 15, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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