Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

This study has been completed.
Sponsor:
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01087710
First received: March 8, 2010
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • asthma free days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • reduction of airway hyper-responsiveness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • time to the first asthma exacerbation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • respiratory function (spirometry) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • need for rescue for exacerbations of asthma symptoms. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: July 2004
Study Completion Date: January 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01087710

Locations
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Stehen DeMichele, PhD Abbott Nutrition
  More Information

No publications provided by Abbott Nutrition

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bobbie Swearengin, Director, Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01087710     History of Changes
Other Study ID Numbers: AK22
Study First Received: March 8, 2010
Last Updated: March 15, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antioxidants
Vitamins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014