Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children
- Conditions
- Asthma
- Registration Number
- NCT01087710
- Lead Sponsor
- Abbott Nutrition
- Brief Summary
To determine the effect of medical food on reducing asthma symptoms in asthmatic children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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.
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Asthma symptoms and/or albuterol use consistent with severe persistent asthma during the run-in period.
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Subject with FEV1 < 80% predicted at visit 1 or FEV1 < 70% predicted at visit 2.
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Two or more hospitalizations for asthma in the past year.
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Subject has received oral, nasal, inhaled, or IM corticosteroids during the preceding month.
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Subject has received leukotriene modifiers, theophylline derivatives, or mast cell stabilizers for asthma within 4 weeks before visit 1
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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
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Subject with active upper respiratory tract infection prior to 4 weeks before visit 1
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Subject with acute sinus disease requiring antibiotic treatment within 1 week before visit
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Subject with an emergency department treatment for asthma within 1 month, prior intubation for asthma, or hospitalization for asthma within 3 months
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Subject has known bleeding disorder and/or is on medication known to have significant anticoagulant effects.
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Subject has known hypersensitivity to any of the ingredients
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Subject is taking either pill, powder, or liquid forms of nutritional and/or health food supplements within the past 4 weeks prior to visit
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Subject unable to tolerate or unwilling to take the full dose of the nutritional study formulas
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Cystic fibrosis or any other chronic lung disease other than asthma.
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Subject having gastroesophogeal reflux undergoing medical treatment
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Significant medical illness other than asthma that could require oral corticosteroids during the study.
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Subject is receiving allergen hyposensitization therapy other than an established maintenance regimen
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Subject has received IV globulins or immunosuppressants.
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Subject is known to be human immunodeficiency virus (HIV) positive.
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Pregnancy or lactation.
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If of child bearing potential, failure to practice abstinence or use of an acceptable birth control method.
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Subject is morbidly obese
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method asthma free days 12 weeks
- Secondary Outcome Measures
Name Time Method reduction of airway hyper-responsiveness 12 weeks time to the first asthma exacerbation 12 weeks respiratory function (spirometry) 12 weeks need for rescue for exacerbations of asthma symptoms. 12 weeks
Trial Locations
- Locations (1)
National Jewish Health
🇺🇸Denver, Colorado, United States
National Jewish Health🇺🇸Denver, Colorado, United States