Asthma in the ElderlyPhase 3NCT02371993
Asthma in the Elderly: A Study of Choline Supplementation
A Phase 3 study testing Choline in people with Asthma in the Elderly, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Asthma in the Elderly
- What is being tested?
- Choline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Asthma
Who cannot join
- No history of smoking more than 10 pack/years,
- no gastrointestinal cancers,
- no liver or kidney disease,
- no bipolar disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Bryn Mawr, Pennsylvania, 19010
About this study
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.
- Conditions
- Asthma in the Elderly
- Being tested
- Choline, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholineDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Choline 650 mg twice daily | Experimental | See above Receives: Dietary Supplement: Choline; Other: Placebo |
| Placebo | Placebo comparator | See above Receives: Dietary Supplement: Choline; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test
Measured: six weeks
Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)
Measured: six weeks
Secondary outcomes (3)
Effect of choline supplementation on peripheral blood eosinophils
Measured: six weeks
Effect of choline supplementation on serum IgE
Measured: six weeks
Effect of choline supplementation on serum homocysteine levels
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in the ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Investigators
- Michele Columbo, M.D., Principal investigator, Rohr and Columbo Asthma, Allergy and Immunology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371993
- Sponsor's protocol ID
- F/N-R15-3427B
- Status last verified
- Oct 2015
- First submitted
- 10 Feb 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26973701
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma in the Elderly: A Study of Choline Supplementation
- ClinicalTrials.gov ID
- NCT02371993
- Acronym / sponsor ID
- F/N-R15-3427B
- Conditions
- Asthma in the Elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.University, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Choline 650 mg twice daily | Experimental | Dietary Supplement: Choline, Other: PlaceboSee above |
| Placebo | Placebo comparator | Dietary Supplement: Choline, Other: PlaceboSee above |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Asthma
Key exclusion criteria (4 listed)
- No history of smoking more than 10 pack/years,
- no gastrointestinal cancers,
- no liver or kidney disease,
- no bipolar disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Choline | Dietary supplement | Choline 650 mg twice daily, Placebo |
| Placebo | Other | Choline 650 mg twice daily, Placebo |
Primary outcome
Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test
Time frame: six weeks
Effect of choline supplementation on spirometric values (FEV1, FEV1/FVC, FEF25-75%)
Time frame: six weeks
3 secondary outcomes
Effect of choline supplementation on peripheral blood eosinophils
Time frame: six weeks
Effect of choline supplementation on serum IgE
Time frame: six weeks
Effect of choline supplementation on serum homocysteine levels
Time frame: six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Derived from this study: PubMed 26973701Columbo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Columbo, M.D. principal investigator
Rohr and Columbo Asthma, Allergy and Immunology Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Choline in people with Asthma in the Elderly, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of choline supplementation on asthma symptoms measured by the Asthma Control Test (time frame: six weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371993, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.