AsthmaNCT02405026
Determine the Prevalence and Severity of Asthma in HIV (Human Immunodeficiency Virus) Infected Patients
An observational study of Asthma and HIV, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the prevalence and severity of asthma in patients with HIV. To determine the immunological phenotype of HIV-infected patients with asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV infected patients. Patients will be identified from the populations of the Duke Infectious Disease Clinic, and surrounding communities. HIV unifected patients. Patients will be identified through the Duke Asthma, Allergy and Airway Center, as well as from primary care physicians, and surrounding communities.
Who may be able to join
- HIV infected asthmatic and non-asthmatic adults ≥18 years
- HIV uninfected asthma adults ≥18 years
- Females of childbearing potential have to be using medically acceptable contraceptive method for the duration of the study.
- Willing and able to give informed consent and adhere to visit/protocol schedules.
- Negative pregnancy test in women of childbearing potential
- For asthma patients: known or possible diagnosis of asthma for at least one year
Who cannot join
- Antibiotic administration for upper respiratory infection within the prior 30 days
- Greater than 10 pack a year smoking history
- No prior use of steroids (systemic) within the past 3 months
- Underlying illnesses that may result in altered lung function
- Students or employees who are under direct supervision of any Project or Core PI/Director.
- Pregnant or nursing mothers.
Show all 9Show fewer
- Poorly controlled concomitant conditions as determined by the investigator.
- Subjects who have had an elective procedure (for example, colonoscopy, cystoscopy, etc.) within less than 2 weeks of the procedure date cannot be enrolled in the HIV Asthma study
- Subjects must delay enrollment by 2 weeks into the HIV Asthma study if they have received a single dose of systemic steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Asthma Allergy and Airway Center
Durham, North Carolina, 27705
About this study
Official title: HIV and Asthma in the Post-ART (Antiretroviral Therapy) Era
The purpose of this study is to determine the prevalence and severity of asthma in patients with HIV. To determine the immunological phenotype of HIV-infected patients with asthma.
Read the detailed description
Prospectively clinically phenotype and the prevalence of asthma in HIV infected patients in the Duke ID Clinic
- HIV infected asthmatic subjects meeting clinical definitions for asthma compared to HIV uninfected asthma subjects identified at the DAAAC and HIV infected non-asthmatic subjects.
- Prospective immunological phenotyping - HIV-infected asthma subjects prospectively identified and clinically phenotyped compared to HIV-uninfected asthma subjects identified at the DAAAC and HIV infected non-asthma subjects.
Regarding the sampling method of probability sample: All samples for HIV infected asthmatic patients, HIV uninfected asthmatic patients and HIV infected non-asthmatics patients will be analyzed.
Retrospectively determine overall asthma prevalence and severity among HIV-infected patients. Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Specimen Biorepository
- HIV-infected asthmatic subjects meeting asthma definition compared to overall asthma prevalence in U.S. population
- HIV-infected asthma subjects meeting asthma definitions compared to matched HIV-infected non-asthma subjects
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV infected patients | HIV infected patients with asthma | |
| HIV uninfected patients | HIV uninfected patients with asthma | |
| HIV infected non-asthmatic patients | HIV infected patients without asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma prevalence of HIV infected subjects currently followed at the Duke Infectious Disease (ID) Clinic compared to HIV uninfected asthma subjects identified at the Duke Asthma, Allergy and Airway Center (DAAAC).
Assessed through Asthma control questionnaire, pulse oximetry, FeNO, Spirometry, Methacholine challenge, Induced sputum for differential, serum periostin, questionnaires
Measured: 12 months
Asthma phenotypic characteristics of HIV infected subjects compared to HIV uninfected asthma subjects and HIV infected non-asthmatic subjects.
Assessed through blood collection
Measured: 12 months
Secondary outcomes (3)
Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets
Assessed through blood sample collection
Measured: 12 months
Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Biorepository
The primary measure of is the quantitative difference in IL-6 between HIV-infected asthmatic subjects and HIV-infected non-asthmatic subjects.
Measured: 12 months
Retrospectively determine overall asthma prevalence among HIV-infected patients
HIV-infected asthmatic subjects meeting electronic health records asthma definition Compared overall asthma prevalence in U.S. population.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2017
- Study completionJul 2017
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 Duke UniversityThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loretta Que, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405026
- Sponsor's protocol ID
- Pro00057348
- Status last verified
- Sep 2017
- First submitted
- 15 Dec 2014
- Last updated
- 3 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV and Asthma in the Post-ART (Antiretroviral Therapy) Era
- ClinicalTrials.gov ID
- NCT02405026
- Acronym / sponsor ID
- Pro00057348
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Apr 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.
The purpose of this study is to determine the prevalence and severity of asthma in patients with HIV. To determine the immunological phenotype of HIV-infected patients with asthma.
Detailed description
Prospectively clinically phenotype and the prevalence of asthma in HIV infected patients in the Duke ID Clinic
- HIV infected asthmatic subjects meeting clinical definitions for asthma compared to HIV uninfected asthma subjects identified at the DAAAC and HIV infected non-asthmatic subjects.
- Prospective immunological phenotyping - HIV-infected asthma subjects prospectively identified and clinically phenotyped compared to HIV-uninfected asthma subjects identified at the DAAAC and HIV infected non-asthma subjects.
Regarding the sampling method of probability sample: All samples for HIV infected asthmatic patients, HIV uninfected asthmatic patients and HIV infected non-asthmatics patients will be analyzed.
Retrospectively determine overall asthma prevalence and severity among HIV-infected patients. Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Specimen Biorepository
- HIV-infected asthmatic subjects meeting asthma definition compared to overall asthma prevalence in U.S. population
- HIV-infected asthma subjects meeting asthma definitions compared to matched HIV-infected non-asthma subjects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HIV infected patients | – | –HIV infected patients with asthma |
| HIV uninfected patients | – | –HIV uninfected patients with asthma |
| HIV infected non-asthmatic patients | – | –HIV infected patients without asthma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients. Patients will be identified from the populations of the Duke Infectious Disease Clinic, and surrounding communities. HIV unifected patients. Patients will be identified through the Duke Asthma, Allergy and Airway Center, as well as from primary care physicians, and surrounding communities.
Key inclusion criteria (6 listed)
- HIV infected asthmatic and non-asthmatic adults ≥18 years
- HIV uninfected asthma adults ≥18 years
- Females of childbearing potential have to be using medically acceptable contraceptive method for the duration of the study.
- Willing and able to give informed consent and adhere to visit/protocol schedules.
- Negative pregnancy test in women of childbearing potential
Key exclusion criteria (9 listed)
- Antibiotic administration for upper respiratory infection within the prior 30 days
- Greater than 10 pack a year smoking history
- No prior use of steroids (systemic) within the past 3 months
- Underlying illnesses that may result in altered lung function
- Students or employees who are under direct supervision of any Project or Core PI/Director.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma prevalence of HIV infected subjects currently followed at the Duke Infectious Disease (ID) Clinic compared to HIV uninfected asthma subjects identified at the Duke Asthma, Allergy and Airway Center (DAAAC).
Time frame: 12 months
Assessed through Asthma control questionnaire, pulse oximetry, FeNO, Spirometry, Methacholine challenge, Induced sputum for differential, serum periostin, questionnaires
Asthma phenotypic characteristics of HIV infected subjects compared to HIV uninfected asthma subjects and HIV infected non-asthmatic subjects.
Time frame: 12 months
Assessed through blood collection
3 secondary outcomes
Prospective immunological phenotyping of Th1/Th2/Th17 cytokines and T cell subsets
Time frame: 12 months
Retrospective immunological phenotyping (circulating cytokines) of HIV-infected patients utilizing available specimens in the Duke HIV Biorepository
Time frame: 12 months
Retrospectively determine overall asthma prevalence among HIV-infected patients
Time frame: 12 months
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 3 Oct 2017.
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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.
Loretta Que, MD principal investigator
Duke University
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 and HIV, run by Duke University 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 6 inclusion and 9 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 3 Oct 2017. 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?
Asthma prevalence of HIV infected subjects currently followed at the Duke Infectious Disease (ID) Clinic compared to HIV uninfected asthma subjects identified at the Duke Asthma, Allergy and Airway Center (DAAAC). (time frame: 12 months). 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?
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 3 Oct 2017.