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Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

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ClinicalTrials.gov Identifier: NCT01087710
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : March 16, 2010
Sponsor:
Information provided by:
Abbott Nutrition

Tracking Information
First Submitted Date  ICMJE March 8, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date March 16, 2010
Study Start Date  ICMJE July 2004
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
asthma free days [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
  • reduction of airway hyper-responsiveness [ Time Frame: 12 weeks ]
  • time to the first asthma exacerbation [ Time Frame: 12 weeks ]
  • respiratory function (spirometry) [ Time Frame: 12 weeks ]
  • need for rescue for exacerbations of asthma symptoms. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children
Official Title  ICMJE 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
Brief Summary To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2010)
43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2006
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01087710
Other Study ID Numbers  ICMJE AK22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bobbie Swearengin, Director, Abbott Nutrition
Study Sponsor  ICMJE Abbott Nutrition
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Stehen DeMichele, PhD Abbott Nutrition
PRS Account Abbott Nutrition
Verification Date March 2010

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