Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

Abbott

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Other: medical food with EPA and GLA, vitamins and minerals

Other: medical food minus EPA and GLA, antioxidant vitamins/minerals

Study type

Interventional

Funder types

Industry

Identifiers

NCT01087710

AK22

Details and patient eligibility

About

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

Enrollment

43 patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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