AsthmaNCT02574351
Study of T-Regulatory Cells in Asthma
An observational study of Asthma, run by Northwell Health at 1 site in United States.
Trial summary
To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- blood draw, breathing test
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Dec 2015
- Phase
- Observational
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Females in good health between the ages of 18-50, with or without asthma.
Who may be able to join
- Obese asthmatics
- Normal weight asthmatics
- Healthy obese
- Health non-obese
- Asthmatic subjects will be recruited:
- If they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18).
Show all 11Show fewer
- If they have stable disease without exacerbation, physician or emergency department visits, or change in asthma medication for the past 4 weeks, inhaled steroids will be allowed.
- Non asthmatic subjects
- Will not have had a prior diagnosis of asthma,
- Have no history of atopy.
- Have no history of lung diseases.
Who cannot join
- > 10 pack year smoking history, or currently smoking
- Pulmonary disease other than asthma.
- History of heart disease
- Weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months.
- Any agents that could potentially alter the inflammatory system such as thiazolidinedione, a statin, or oral steroid therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore LIJ Health System
New Hyde Park, New York, 11040
About this study
To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.
Read the detailed description
The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma.
This is an exploratory study to investigate the following:
- To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma.
- To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.
- Conditions
- Asthma
- Being tested
- blood draw, breathing test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood draw, breathing testBiological
A blood draw,breathing test will be performed on every participant
| Study group | Role | What they receive |
|---|---|---|
| obese asthmatic | Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group. Receives: Biological: blood draw, breathing test | |
| normal asthmatic | Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group Receives: Biological: blood draw, breathing test | |
| obese control | Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group. Receives: Biological: blood draw, breathing test | |
| normal control | Participants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group. Receives: Biological: blood draw, breathing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startMay 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rubin Cohen, MD, Principal investigator, North Shore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574351
- Sponsor's protocol ID
- 11-076B
- Status last verified
- Jan 2016
- First submitted
- 1 Nov 2013
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of T-Regulatory Cells in Asthma
- ClinicalTrials.gov ID
- NCT02574351
- Acronym / sponsor ID
- 11-076B
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Oct 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.
To study whether the immune response as directed by regulatory T cells is different between obese asthmatics, normal weight asthmatics and healthy controls.
Detailed description
The investigators hypothesize that the increase in asthma severity in obese patients is, at least in part, related to a defective number or function of regulatory T cells (Tregs). That is in the obese asthmatic subject a defective Treg profile would augment the inflammation of asthma (a synergistic effect). Alternatively, that Treg dysfunction in obesity might affect asthma independently (an additive effect). To test these hypotheses, the investigators plan to conduct an observational controlled study to compare Treg profile in obese and normal-weight individuals with and without asthma.
This is an exploratory study to investigate the following:
- To determine whether Treg number and function differs between obese and normal-weight individuals with and without asthma.
- To determine whether serum leptin levels differ between obese and normal-weight individuals with and without asthma.
Study design
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| obese asthmatic | – | Biological: blood draw, breathing testParticipants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group. |
| normal asthmatic | – | Biological: blood draw, breathing testParticipants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group |
| obese control | – | Biological: blood draw, breathing testParticipants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group. |
| normal control | – | Biological: blood draw, breathing testParticipants from this group will be included in this study. A blood draw, breathing test will be performed to see if there is a difference in the t-regulatory cells amongst this group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Females in good health between the ages of 18-50, with or without asthma.
Key inclusion criteria (11 listed)
- Obese asthmatics
- Normal weight asthmatics
- Healthy obese
- Health non-obese
- If they have a physician diagnosis of adult onset asthma (asthma diagnosed after the age of 18).
Key exclusion criteria (5 listed)
- > 10 pack year smoking history, or currently smoking
- Pulmonary disease other than asthma.
- History of heart disease
- Weight loss greater than 10 kg, or greater than 10% initial body weight within the past 3 months.
- Any agents that could potentially alter the inflammatory system such as thiazolidinedione, a statin, or oral steroid therapy.
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 |
|---|---|---|
| blood draw, breathing testA blood draw,breathing test will be performed on every participant | Biological | normal asthmatic, normal control, obese asthmatic, obese control |
Primary outcome
Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma.
Time frame: 3 years
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 Jan 2016.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Rubin Cohen, MD principal investigator
North Shore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Northwell Health 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 11 inclusion and 5 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 Jan 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Difference of treg and serum leptin levels among obese and normal weight individuals with and without asthma. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2016.