Asthma in the Elderly: A Study of Choline Supplementation
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2015
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
February 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedOctober 29, 2015
October 1, 2015
5 months
February 10, 2015
October 28, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test
six weeks
Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)
six weeks
Secondary Outcomes (3)
Effect of choline supplementation on peripheral blood eosinophils
six weeks
Effect of choline supplementation on serum IgE
six weeks
Effect of choline supplementation on serum homocysteine levels
six weeks
Study Arms (2)
Choline 650 mg twice daily
EXPERIMENTALSee above
Placebo
PLACEBO COMPARATORSee above
Interventions
Eligibility Criteria
You may qualify if:
- Asthma
You may not qualify if:
- No history of smoking more than 10 pack/years,
- no gastrointestinal cancers,
- no liver or kidney disease,
- no bipolar disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Bryn Mawr, Pennsylvania, 19010, United States
Related Publications (1)
Columbo M, Rohr AS. Asthma in the elderly: the effect of choline supplementation. Allergy Asthma Clin Immunol. 2016 Mar 11;12:15. doi: 10.1186/s13223-016-0121-5. eCollection 2016.
PMID: 26973701DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Columbo, M.D.
Rohr and Columbo Asthma, Allergy and Immunology Specialists
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2015
First Posted
February 26, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
October 29, 2015
Record last verified: 2015-10