Working… Menu

Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01087710
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Information provided by:
Abbott Nutrition

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

Condition or disease Intervention/treatment Phase
Asthma Other: medical food with EPA and GLA, vitamins and minerals Other: medical food minus EPA and GLA, antioxidant vitamins/minerals Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

Primary Outcome Measures :
  1. asthma free days [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. reduction of airway hyper-responsiveness [ Time Frame: 12 weeks ]
  2. time to the first asthma exacerbation [ Time Frame: 12 weeks ]
  3. respiratory function (spirometry) [ Time Frame: 12 weeks ]
  4. need for rescue for exacerbations of asthma symptoms. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01087710

Layout table for location information
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
Abbott Nutrition
Layout table for investigator information
Study Chair: Stehen DeMichele, PhD Abbott Nutrition
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bobbie Swearengin, Director, Abbott Nutrition Identifier: NCT01087710    
Other Study ID Numbers: AK22
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: March 16, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents