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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

March 8, 2010
March 15, 2010
July 2004
December 2005   (final data collection date for primary outcome measure)
asthma free days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01087710 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Other: medical food with EPA and GLA, vitamins and minerals
    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
  • Experimental: novel nutritional formula
    Intervention: Other: medical food with EPA and GLA, vitamins and minerals
  • Active Comparator: Control nutritional product
    1 8oz serving per day for 12 weeks
    Intervention: Other: medical food minus EPA and GLA, antioxidant vitamins/minerals
Covar R, Gleason M, Macomber B, Stewart L, Szefler P, Engelhardt K, Murphy J, Liu A, Wood S, DeMichele S, Gelfand EW, Szefler SJ. Impact of a novel nutritional formula on asthma control and biomarkers of allergic airway inflammation in children. Clin Exp Allergy. 2010 Aug;40(8):1163-74. doi: 10.1111/j.1365-2222.2010.03523.x. Epub 2010 Jun 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
January 2006
December 2005   (final data collection date for primary outcome measure)

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
Both
6 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01087710
AK22
No
Bobbie Swearengin, Director, Abbott Nutrition
Abbott Nutrition
Not Provided
Study Chair: Stehen DeMichele, PhD Abbott Nutrition
Abbott Nutrition
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP