Effect of Medical Food on Reducing Asthma Symptoms in Asthmatic Children

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087710
• Other study ID #: AK22
• Status: Completed
• Phase: Phase 2
• First received: March 8, 2010
• Last updated: March 15, 2010
• Start date: July 2004
• Est. completion date: January 2006

Study information

• Verified date: March 2010
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• medical food with EPA and GLA, vitamins and minerals
1 8oz serving per day for 12 weeks
• medical food minus EPA and GLA, antioxidant vitamins/minerals
1 8oz serving a day for 12 weeks

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asthma free days		12 weeks	No
Secondary	reduction of airway hyper-responsiveness		12 weeks	No
Secondary	time to the first asthma exacerbation		12 weeks	No
Secondary	respiratory function (spirometry)		12 weeks	No
Secondary	need for rescue for exacerbations of asthma symptoms.		12 weeks	No