Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

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

Tracking Information

• First Submitted Date: March 8, 2010
• First Posted Date: March 16, 2010
• Last Update Posted Date: March 16, 2010
• Study Start Date: July 2004
• Actual Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 15, 2010): asthma free days [ Time Frame: 12 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children
• 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
• Brief Summary: To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Asthma

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 15, 2010): 43
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2006
• Actual Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years to 14 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01087710
• Other Study ID Numbers: AK22
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bobbie Swearengin, Director, Abbott Nutrition
• Study Sponsor: Abbott Nutrition
• Collaborators: Not Provided

Investigators

• Study Chair: Stehen DeMichele, PhD; Abbott Nutrition

• PRS Account: Abbott Nutrition
• Verification Date: March 2010