Asthma in the Elderly: A Study of Choline Supplementation

Asthma in the Elderly Clinical Trial

Official title:

Asthma in the Elderly: A Study of Choline Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371993
• Other study ID #: F/N-R15-3427B
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2015
• Last updated: October 28, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Asthma in the elderly is poorly understood, as most studies have not included this patient group. In a previous study of adults with asthma, choline supplementation had a positive effect on asthma symptoms and allowed to decrease asthma pharmacologic treatment. The present study is a randomized, double-blind, placebo-controlled, cross-over study of choline supplementation. The investigators will study the effect of choline 650 mg taken orally twice daily x 6 weeks versus placebo on asthma symptom scores (Asthma Control Test) and spirometric values (FEV1, FEV1/FVC, FEF25-75%). The investigators will also look at the effect of choline supplementation on peripheral blood eosinophils, serum immunoglobulin E (IgE) and homocysteine levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Asthma

Exclusion Criteria:

• No history of smoking more than 10 pack/years,

• no gastrointestinal cancers,

• no liver or kidney disease,

• no bipolar disorder.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Asthma in the Elderly

Intervention

Dietary Supplement:
• Choline

Other:
• Placebo

Locations

Country	Name	City	State
United States	Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.	Bryn Mawr	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test		six weeks	No
Primary	Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)		six weeks	No
Secondary	Effect of choline supplementation on peripheral blood eosinophils		six weeks	No
Secondary	Effect of choline supplementation on serum IgE		six weeks	No
Secondary	Effect of choline supplementation on serum homocysteine levels		six weeks	No