AsthmaSHOPNCT02975258
Adiposity and Airway Inflammation in HIV-Associated Airway Disease
An observational study of Asthma and HIV, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goals of this study are to 1) examine the relationships among inflammation, obesity, and asthma in people with HIV and 2) to test if special subtypes of cells or markers are present in the blood and lungs of people with HIV with asthma compared to those without asthma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Blood draw, Questionnaires and Spirometry
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Sep 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV positive individuals in the Pittsburgh area
Who may be able to join
- 18 years of age or older
- Subject who have been previously determined to be HIV positive through testing
Who cannot join
- Pregnancy or breast-feeding
- Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.)
- Heart condition such as tachycardia, angina or arrhythmias
- Acute respiratory infection: increasing respiratory symptoms or fever (temperature >100.4°F [38°C]) within 4 weeks of study entry
- Hospitalization within 4 weeks of study entry
- Uncontrolled hypertension at screening visit (systolic > 160 mm Hg or diastolic > 100 mm Hg) from an average of two or more readings (participant may return for screening after blood pressure is controlled)
Show all 9Show fewer
- Active cancer requiring systemic chemotherapy or radiation
- Active infection of lungs, brain, or abdomen; or intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator
- History of prior lung resection
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
The goals of this study are to 1) examine the relationships among inflammation, obesity, and asthma in people with HIV and 2) to test if special subtypes of cells or markers are present in the blood and lungs of people with HIV with asthma compared to those without asthma.
Read the detailed description
The proposed study involves the recruitment of participant population and the use of data from the existing research study cohorts that have been recruited and have provided informed consent for participation. Participants meet all inclusion/exclusion criteria will be enrolled into the study. Participants in the existing research study cohorts have pulmonary function testing, chest CT scans, and blood draws at each study visit which occurs every 18 months for 3 visits. Some of the study procedures may not be repeated if they were done as part of other research projects.
- Main study visit The following research procedures may be performed over the course of one or more visits to accommodate scheduling needs. The study visit will take place at the Montefiore Clinical and Translational Research Center and the University of Pittsburgh Asthma Institute in the University of Pittsburgh Medical Center - Montefiore Hospital and may take up to 4 hours to complete.
- Informed consent
- Medical history review and demographics
- Review of inclusion/exclusion criteria
- Physical examination to include vital signs, weight and height, waist, hip, and thigh circumferences.
- Urine pregnancy test for female of childbearing potential
- Asthma-focused and quality of life questionnaire
- Exhaled Nitric Oxide (eNO) measurement
- Spirometry
- Methacholine challenge testing - will not need to be repeated if the participant had done this as part of another study in the past 6 months.
- Chest/Abdominal CT scans (If the participant has had the Chest CT scan done within 6 months as part of other research study, they will not be repeated for study purposes. Only the Abdominal CT will be performed)
- Research blood sampling for biomarker analyses - some of this blood will also be used for pre-bronchoscopy testing in the case that the participant qualifies and is interested in undergoing part 2, the bronchoscopy visit.
- Adipose tissue biopsy (Fat Biopsy): performed on participants with a BMI≥25). This will be repeated if done previously because testing to be done on the fat will be different than what had been tested on the fat previously.
- Optional sub-study
On a separate visit, only a subset of 60 selected participants will be asked to undergo the following procedures to obtain additional lung biological samples. This visit is optional for participants who are willing to participate in the bronchoscopy portion. The investigators will try to recruit an equal number (n=15 per group) of obese asthmatics, obese non-asthmatics, non-obese asthmatics, and non-obese non-asthmatics. The visit will take place in the Montefiore Clinical Translational Research Center (MUH-CTRC). The bronchoscopy procedure will take about 30-45 minutes, but the preparation and recovery time will usually make the visit about 4-8 hours total.
Participants will be expected to fast for 8 hours prior to the bronchoscopy procedure and refrain from drinking any liquids the day of the procedure. Participants may take their usual medicines with sips of water.
- Clinical laboratory testing to include complete blood count/differential/platelet count, prothrombin time/partial thromboplastin time, international Normalized Ratio, blood urea nitrogen, and creatinine prior to bronchoscopy. If the patient refuses the first blood draw, the sample is inadequate, or the labs were run more than 30 days prior to the bronchoscopy visit, a second blood sample of up to 1 tablespoon may be drawn prior to the bronchoscopy procedure to ensure the patient is healthy enough for the procedure.
If Methacholine challenge was done more than 30 days prior to the visit two date, pulmonary function tests will be repeated.
- Oral Wash: participants will be asked to gargle with salt water for 1 minute and then spit into a container to provide a sample of approximately 10mls (2 teaspoons) at this study visit.
- Tongue Scraping: tongue blade or similar object will be used to scrape the participant's tongue. This sample will be used to determine what bacteria are on the participant's tongue. This procedure should only take minutes and is not painful.
- Participants will then rinse with 10cc's of Listerine. This is to assure that there are no bacteria left behind in the participant's mouth prior to the bronchoscopy.
- Bronchoscopy with bronchoalveolar lavage (BAL), endobronchial brushing and biopsy
Under local anesthesia, participants will undergo bronchoscopy with BAL for microbiologic specimens. A light intravenous anesthetic will be titrated to provide participant comfort if necessary. Vitals signs will be monitored continuously before, during, and after the procedure. This procedure consists of 3 stages.
- Pulmonary Lavage: During pulmonary lavage, five 50 mL washes of sterile salt-water solution will be injected through the bronchoscope. Fluid will be collected with gentle suctioning for research studies.
- Bronchial Brushing: A small brush will be introduced through the bronchoscope and gently rubbed over a very small part of the surface of the lungs. Approximately 10 brushes will be performed to collect epithelial cells.
- Endobronchial Biopsy: While the bronchoscope is inserted, another small instrument will be passed through the bronchoscope to take small samples (biopsies) of tissue from the walls of the airways. Up to 5 samples may be taken during this procedure.
Following the bronchoscopy procedure, participants will be closely monitored in the bronchoscopy recovery area or return to the CTRC. Rarely, the participant's asthma may worsen during or after the procedure. Appropriate medical treatments or overnight observation will be provided if needed. Participants will not be allowed to drive home after the bronchoscopy. This is because the sedatives used during the procedure may decrease driving ability. The investigators will ask for the contact name and number of the person that will pick up the participant after the bronchoscopy
- Being tested
- Blood draw, Questionnaires, Spirometry, Methacholine challenge test, Quantitative CT scans
- Keywords
- HIV, Asthma, Adiposity, Lung disease, Weight, Fat, Obese
- Medical subject headings
- Asthma, Obesity, Lung Diseases, Body Weight, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
Blood will be drawn for plasma, serum, and peripheral blood mononuclear cells.
QuestionnairesOther
The following questionnaires are administered to participants by study personnel: Gingo Asthma Questionnaire (GAQ) and the Asthma Quality of Life questionnaire (AQL).
SpirometryProcedure or surgery
Also called Lung function testing
Spirometry is a simple breathing test that measures the amount of air in one's lungs and how well one can move that air by forcefully blowing 3 or more times into a mouthpiece. A series of these maneuvers will be performed under the instruction of a respiratory technician or respiratory therapist.
Methacholine challenge testProcedure or surgery
Also called Asthma Test
A methacholine challenge is a common test often used to support a diagnosis of asthma. The test consists of inhaling increasing doses of methacholine through a nebulizer to assess how quickly the participant's airways narrow.
Quantitative CT scansRadiation
Also called CT scan of the chest, CT scan of the abdomen
There will be a standard chest CT and an abdominal CT. The CT scans capture contiguous volume scans acquired at slice thicknesses of 5.0 mm in the axial plane and reconstructed with 512 x 512 pixel matrices. CT examinations will encompass the entire thorax and the abdomen and will be performed during a breath-hold at end-inspiration. The investigators will measure % of lung tissue below a threshold for emphysema (i.e. -950 Hounsfield units). Measurements have been histologically-verified and give reproducible measurements. The data set is assembled and analyzed with the image data anonymized. If the participant has had a research chest CT scan done recently, only the abdomen CT will be done.
Urine pregnancy testProcedure or surgery
All female participants with childbearing potential will be asked to provide a urine sample for pregnancy testing. The result of the pregnancy test must be negative in order for her to be in this research study.
Adipose biopsyProcedure or surgery
Also called Fat pad biopsy, Fat biopsy
The doctor will obtain a sample of fat cells from the participant's abdomen. Numbing medicine will be applied. A needle is placed through the skin \& into the fat pad under the skin. A blunt-tip hollow cannula is then used to aspirate fat tissue through the incision.
Exhaled nitric oxide measurementProcedure or surgery
Also called ENO measurement
The investigators will measure concentrations of exhaled nitric oxide by asking the participant to inhale deeply, and then exhale very slowly into a mouthpiece for between 10-15 seconds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse interaction of adiposity and HIV-associated inflammation in asthma susceptibility and airway remodeling in HIV
The investigator will test association of adiposity (body mass index, waist circumference, computed tomography (CT)-measured visceral adiposity) with prevalence of asthma and longitudinal progression of airway obstruction. the blood and lungs of people with HIV with asthma compared to those without asthma.
Measured: Baseline
Secondary outcomes (5)
Correlation between leptin and asthma susceptibility in HIV.
Leptin, an obesity-related inflammatory marker, levels will be compared between HIV+ asthmatics and non-asthmatics and correlated with airway remodeling on endobronchial biopsy and CT.
Measured: Baseline
Correlation between adiponectin, asthma susceptibility, and airway remodeling in HIV.
Adiponectin, an obesity-related inflammatory marker, levels will be compared between HIV+ asthmatics and non-asthmatics and correlated with airway remodeling on endobronchial biopsy and CT.
Measured: Baseline
Adipose tissue-related inflammation contributes to asthma susceptibility and airway remodeling in HIV.
Using abdominal adipose tissue biopsies, the investigators will phenotype adipose-specific inflammatory cells and pathways and determine associations with asthma, airway remodeling, and longitudinal progression of airway obstruction.
Measured: Baseline
Low L-arginine increases asthma risk and airway remodeling in HIV.
The investigator will measure L-arginine in serum and bronchoalveolar lavage samples to compare levels between HIV+ asthmatics and non-asthmatics and correlate L-arginine with CT and biopsy measures of airway remodeling.
Measured: Baseline
Low ADMA increases asthma risk and airway remodeling in HIV.
The investigator will measure ADMA in serum and bronchoalveolar lavage samples to compare levels between HIV+ asthmatics and non-asthmatics and correlate ADMA with CT and biopsy measures of airway remodeling.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (120)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alison Morris, University of Pittsburgh
- Investigators
- Alison Morris, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975258
- Sponsor's protocol ID
- PRO15070529
- Other IDs
- 1R56HL128134-01A1
- Acronym
- SHOP
- Status last verified
- Oct 2017
- First submitted
- 1 Nov 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Gingo MR, Wenzel SE, Steele C, Kessinger CJ, Lucht L, Lawther T, Busch M, Hillenbrand ME, Weinman R, Slivka WA, McMahon DK, Zhang Y, Sciurba FC, Morris A. Asthma diagnosis and airway bronchodilator response in HIV-infected patients. J Allergy Clin Immunol. 2012 Mar;129(3):708-714.e8. doi: 10.1016/j.jaci.2011.11.015. Epub 2011 Dec 15.
PubMed 22177327Miranda C, Busacker A, Balzar S, Trudeau J, Wenzel SE. Distinguishing severe asthma phenotypes: role of age at onset and eosinophilic inflammation. J Allergy Clin Immunol. 2004 Jan;113(1):101-8. doi: 10.1016/j.jaci.2003.10.041.
PubMed 14713914Holguin F, Comhair SA, Hazen SL, Powers RW, Khatri SS, Bleecker ER, Busse WW, Calhoun WJ, Castro M, Fitzpatrick AM, Gaston B, Israel E, Jarjour NN, Moore WC, Peters SP, Teague WG, Chung KF, Erzurum SC, Wenzel SE. An association between L-arginine/asymmetric dimethyl arginine balance, obesity, and the age of asthma onset phenotype. Am J Respir Crit Care Med. 2013 Jan 15;187(2):153-9. doi: 10.1164/rccm.201207-1270OC. Epub 2012 Nov 29.
PubMed 23204252Gingo MR, George MP, Kessinger CJ, Lucht L, Rissler B, Weinman R, Slivka WA, McMahon DK, Wenzel SE, Sciurba FC, Morris A. Pulmonary function abnormalities in HIV-infected patients during the current antiretroviral therapy era. Am J Respir Crit Care Med. 2010 Sep 15;182(6):790-6. doi: 10.1164/rccm.200912-1858OC. Epub 2010 Jun 3.
PubMed 20522793Crothers K, Thompson BW, Burkhardt K, Morris A, Flores SC, Diaz PT, Chaisson RE, Kirk GD, Rom WN, Huang L; Lung HIV Study. HIV-associated lung infections and complications in the era of combination antiretroviral therapy. Proc Am Thorac Soc. 2011 Jun;8(3):275-81. doi: 10.1513/pats.201009-059WR.
PubMed 21653528Gingo MR, Balasubramani GK, Kingsley L, Rinaldo CR Jr, Alden CB, Detels R, Greenblatt RM, Hessol NA, Holman S, Huang L, Kleerup EC, Phair J, Sutton SH, Seaberg EC, Margolick JB, Wisniewski SR, Morris A. The impact of HAART on the respiratory complications of HIV infection: longitudinal trends in the MACS and WIHS cohorts. PLoS One. 2013;8(3):e58812. doi: 10.1371/journal.pone.0058812. Epub 2013 Mar 12.
PubMed 23554932Grubb JR, Moorman AC, Baker RK, Masur H. The changing spectrum of pulmonary disease in patients with HIV infection on antiretroviral therapy. AIDS. 2006 May 12;20(8):1095-107. doi: 10.1097/01.aids.0000226949.64600.f9. No abstract available.
PubMed 16691060Llibre JM, Falco V, Tural C, Negredo E, Pineda JA, Munoz J, Ortega E, Videla S, Sirera G, Martinez E, Miralles C, Iribarren J, Galindo MJ, Domingo P, d'Arminio-Monforte A, Miro JM, Clotet B. The changing face of HIV/AIDS in treated patients. Curr HIV Res. 2009 Jul;7(4):365-77. doi: 10.2174/157016209788680633.
PubMed 19601771Crothers K, Huang L, Goulet JL, Goetz MB, Brown ST, Rodriguez-Barradas MC, Oursler KK, Rimland D, Gibert CL, Butt AA, Justice AC. HIV infection and risk for incident pulmonary diseases in the combination antiretroviral therapy era. Am J Respir Crit Care Med. 2011 Feb 1;183(3):388-95. doi: 10.1164/rccm.201006-0836OC. Epub 2010 Sep 17.
PubMed 20851926Akinbami LJ, Moorman JE, Bailey C, Zahran HS, King M, Johnson CA, Liu X. Trends in asthma prevalence, health care use, and mortality in the United States, 2001-2010. NCHS Data Brief. 2012 May;(94):1-8.
PubMed 22617340Moorman JE, Zahran H, Truman BI, Molla MT; Centers for Disease Control and Prevention (CDC). Current asthma prevalence - United States, 2006-2008. MMWR Suppl. 2011 Jan 14;60(1):84-6. No abstract available.
PubMed 21430629Gingo MR, Balasubramani GK, Rice TB, Kingsley L, Kleerup EC, Detels R, Seaberg EC, Greenblatt RM, Holman S, Huang L, Sutton SH, Bertolet M, Morris A. Pulmonary symptoms and diagnoses are associated with HIV in the MACS and WIHS cohorts. BMC Pulm Med. 2014 Apr 30;14:75. doi: 10.1186/1471-2466-14-75.
PubMed 24884738Lehmann S, Bakke PS, Eide GE, Gulsvik A. Bronchodilator response to adrenergic beta2-agonists: relationship to symptoms in an adult community. Respir Med. 2007 Jun;101(6):1183-90. doi: 10.1016/j.rmed.2006.11.007. Epub 2006 Dec 22.
PubMed 17188486Shore SA. Obesity, airway hyperresponsiveness, and inflammation. J Appl Physiol (1985). 2010 Mar;108(3):735-43. doi: 10.1152/japplphysiol.00749.2009. Epub 2009 Oct 29.
PubMed 19875711Beuther DA, Sutherland ER. Overweight, obesity, and incident asthma: a meta-analysis of prospective epidemiologic studies. Am J Respir Crit Care Med. 2007 Apr 1;175(7):661-6. doi: 10.1164/rccm.200611-1717OC. Epub 2007 Jan 18.
PubMed 17234901
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiposity and Airway Inflammation in HIV-Associated Airway Disease
- ClinicalTrials.gov ID
- NCT02975258
- Acronym / sponsor ID
- SHOP / PRO15070529
- Keywords
- HIV, Asthma, Adiposity, Lung disease, Weight, Fat, Obese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 29 Nov 2016 (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 goals of this study are to 1) examine the relationships among inflammation, obesity, and asthma in people with HIV and 2) to test if special subtypes of cells or markers are present in the blood and lungs of people with HIV with asthma compared to those without asthma.
Detailed description
The proposed study involves the recruitment of participant population and the use of data from the existing research study cohorts that have been recruited and have provided informed consent for participation. Participants meet all inclusion/exclusion criteria will be enrolled into the study. Participants in the existing research study cohorts have pulmonary function testing, chest CT scans, and blood draws at each study visit which occurs every 18 months for 3 visits. Some of the study procedures may not be repeated if they were done as part of other research projects.
- Main study visit The following research procedures may be performed over the course of one or more visits to accommodate scheduling needs. The study visit will take place at the Montefiore Clinical and Translational Research Center and the University of Pittsburgh Asthma Institute in the University of Pittsburgh Medical Center - Montefiore Hospital and may take up to 4 hours to complete.
- Informed consent
- Medical history review and demographics
- Review of inclusion/exclusion criteria
- Physical examination to include vital signs, weight and height, waist, hip, and thigh circumferences.
- Urine pregnancy test for female of childbearing potential
- Asthma-focused and quality of life questionnaire
- Exhaled Nitric Oxide (eNO) measurement
- Spirometry
- Methacholine challenge testing - will not need to be repeated if the participant had done this as part of another study in the past 6 months.
- Chest/Abdominal CT scans (If the participant has had the Chest CT scan done within 6 months as part of other research study, they will not be repeated for study purposes. Only the Abdominal CT will be performed)
- Research blood sampling for biomarker analyses - some of this blood will also be used for pre-bronchoscopy testing in the case that the participant qualifies and is interested in undergoing part 2, the bronchoscopy visit.
- Adipose tissue biopsy (Fat Biopsy): performed on participants with a BMI≥25). This will be repeated if done previously because testing to be done on the fat will be different than what had been tested on the fat previously.
- Optional sub-study
On a separate visit, only a subset of 60 selected participants will be asked to undergo the following procedures to obtain additional lung biological samples. This visit is optional for participants who are willing to participate in the bronchoscopy portion. The investigators will try to recruit an equal number (n=15 per group) of obese asthmatics, obese non-asthmatics, non-obese asthmatics, and non-obese non-asthmatics. The visit will take place in the Montefiore Clinical Translational Research Center (MUH-CTRC). The bronchoscopy procedure will take about 30-45 minutes, but the preparation and recovery time will usually make the visit about 4-8 hours total.
Participants will be expected to fast for 8 hours prior to the bronchoscopy procedure and refrain from drinking any liquids the day of the procedure. Participants may take their usual medicines with sips of water.
- Clinical laboratory testing to include complete blood count/differential/platelet count, prothrombin time/partial thromboplastin time, international Normalized Ratio, blood urea nitrogen, and creatinine prior to bronchoscopy. If the patient refuses the first blood draw, the sample is inadequate, or the labs were run more than 30 days prior to the bronchoscopy visit, a second blood sample of up to 1 tablespoon may be drawn prior to the bronchoscopy procedure to ensure the patient is healthy enough for the procedure.
If Methacholine challenge was done more than 30 days prior to the visit two date, pulmonary function tests will be repeated.
- Oral Wash: participants will be asked to gargle with salt water for 1 minute and then spit into a container to provide a sample of approximately 10mls (2 teaspoons) at this study visit.
- Tongue Scraping: tongue blade or similar object will be used to scrape the participant's tongue. This sample will be used to determine what bacteria are on the participant's tongue. This procedure should only take minutes and is not painful.
- Participants will then rinse with 10cc's of Listerine. This is to assure that there are no bacteria left behind in the participant's mouth prior to the bronchoscopy.
- Bronchoscopy with bronchoalveolar lavage (BAL), endobronchial brushing and biopsy
Under local anesthesia, participants will undergo bronchoscopy with BAL for microbiologic specimens. A light intravenous anesthetic will be titrated to provide participant comfort if necessary. Vitals signs will be monitored continuously before, during, and after the procedure. This procedure consists of 3 stages.
- Pulmonary Lavage: During pulmonary lavage, five 50 mL washes of sterile salt-water solution will be injected through the bronchoscope. Fluid will be collected with gentle suctioning for research studies.
- Bronchial Brushing: A small brush will be introduced through the bronchoscope and gently rubbed over a very small part of the surface of the lungs. Approximately 10 brushes will be performed to collect epithelial cells.
- Endobronchial Biopsy: While the bronchoscope is inserted, another small instrument will be passed through the bronchoscope to take small samples (biopsies) of tissue from the walls of the airways. Up to 5 samples may be taken during this procedure.
Following the bronchoscopy procedure, participants will be closely monitored in the bronchoscopy recovery area or return to the CTRC. Rarely, the participant's asthma may worsen during or after the procedure. Appropriate medical treatments or overnight observation will be provided if needed. Participants will not be allowed to drive home after the bronchoscopy. This is because the sedatives used during the procedure may decrease driving ability. The investigators will ask for the contact name and number of the person that will pick up the participant after the bronchoscopy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive individuals in the Pittsburgh area
Key inclusion criteria (2 listed)
- 18 years of age or older
- Subject who have been previously determined to be HIV positive through testing
Key exclusion criteria (9 listed)
- Pregnancy or breast-feeding
- Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.)
- Heart condition such as tachycardia, angina or arrhythmias
- Acute respiratory infection: increasing respiratory symptoms or fever (temperature >100.4°F [38°C]) within 4 weeks of study entry
- Hospitalization within 4 weeks of study entry
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 drawBlood will be drawn for plasma, serum, and peripheral blood mononuclear cells. | Procedure or surgery | – |
| QuestionnairesThe following questionnaires are administered to participants by study personnel: Gingo Asthma Questionnaire (GAQ) and the Asthma Quality of Life questionnaire (AQL). | Other | – |
| SpirometryAlso: Lung function testingSpirometry is a simple breathing test that measures the amount of air in one's lungs and how well one can move that air by forcefully blowing 3 or more times into a mouthpiece. A series of these maneuvers will be performed under the instruction of a respiratory technician or respiratory therapist. | Procedure or surgery | – |
| Methacholine challenge testAlso: Asthma TestA methacholine challenge is a common test often used to support a diagnosis of asthma. The test consists of inhaling increasing doses of methacholine through a nebulizer to assess how quickly the participant's airways narrow. | Procedure or surgery | – |
| Quantitative CT scansAlso: CT scan of the chest, CT scan of the abdomenThere will be a standard chest CT and an abdominal CT. The CT scans capture contiguous volume scans acquired at slice thicknesses of 5.0 mm in the axial plane and reconstructed with 512 x 512 pixel matrices. CT examinations will encompass the entire thorax and the abdomen and will be performed during a breath-hold at end-inspiration. The investigators will measure % of lung tissue below a threshold for emphysema (i.e. -950 Hounsfield units). Measurements have been histologically-verified and give reproducible measurements. The data set is assembled and analyzed with the image data anonymized. If the participant has had a research chest CT scan done recently, only the abdomen CT will be done. | Radiation | – |
| Urine pregnancy testAll female participants with childbearing potential will be asked to provide a urine sample for pregnancy testing. The result of the pregnancy test must be negative in order for her to be in this research study. | Procedure or surgery | – |
| Adipose biopsyAlso: Fat pad biopsy, Fat biopsyThe doctor will obtain a sample of fat cells from the participant's abdomen. Numbing medicine will be applied. A needle is placed through the skin \& into the fat pad under the skin. A blunt-tip hollow cannula is then used to aspirate fat tissue through the incision. | Procedure or surgery | – |
| Exhaled nitric oxide measurementAlso: ENO measurementThe investigators will measure concentrations of exhaled nitric oxide by asking the participant to inhale deeply, and then exhale very slowly into a mouthpiece for between 10-15 seconds. | Procedure or surgery | – |
Primary outcome
Adverse interaction of adiposity and HIV-associated inflammation in asthma susceptibility and airway remodeling in HIV
Time frame: Baseline
The investigator will test association of adiposity (body mass index, waist circumference, computed tomography (CT)-measured visceral adiposity) with prevalence of asthma and longitudinal progression of airway obstruction. the blood and lungs of people with HIV with asthma compared to those without asthma.
5 secondary outcomes
Correlation between leptin and asthma susceptibility in HIV.
Time frame: Baseline
Correlation between adiponectin, asthma susceptibility, and airway remodeling in HIV.
Time frame: Baseline
Adipose tissue-related inflammation contributes to asthma susceptibility and airway remodeling in HIV.
Time frame: Baseline
Low L-arginine increases asthma risk and airway remodeling in HIV.
Time frame: Baseline
Low ADMA increases asthma risk and airway remodeling in HIV.
Time frame: Baseline
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 13 Oct 2017.
- Background: PubMed 22177327Gingo MR, Wenzel SE, Steele C, Kessinger CJ, Lucht L, Lawther T, Busch M, Hillenbrand ME, Weinman R, Slivka WA, McMahon DK, Zhang Y, Sciurba FC, Morris A. Asthma diagnosis and airway bronchodilator response in HIV-infected patients. J Allergy Clin Immunol. 2012 Mar;129(3):708-714.e8. doi: 10.1016/j.jaci.2011.11.015. Epub 2011 Dec 15.
- Background: PubMed 14713914Miranda C, Busacker A, Balzar S, Trudeau J, Wenzel SE. Distinguishing severe asthma phenotypes: role of age at onset and eosinophilic inflammation. J Allergy Clin Immunol. 2004 Jan;113(1):101-8. doi: 10.1016/j.jaci.2003.10.041.
- Background: PubMed 23204252Holguin F, Comhair SA, Hazen SL, Powers RW, Khatri SS, Bleecker ER, Busse WW, Calhoun WJ, Castro M, Fitzpatrick AM, Gaston B, Israel E, Jarjour NN, Moore WC, Peters SP, Teague WG, Chung KF, Erzurum SC, Wenzel SE. An association between L-arginine/asymmetric dimethyl arginine balance, obesity, and the age of asthma onset phenotype. Am J Respir Crit Care Med. 2013 Jan 15;187(2):153-9. doi: 10.1164/rccm.201207-1270OC. Epub 2012 Nov 29.
- Background: PubMed 20522793Gingo MR, George MP, Kessinger CJ, Lucht L, Rissler B, Weinman R, Slivka WA, McMahon DK, Wenzel SE, Sciurba FC, Morris A. Pulmonary function abnormalities in HIV-infected patients during the current antiretroviral therapy era. Am J Respir Crit Care Med. 2010 Sep 15;182(6):790-6. doi: 10.1164/rccm.200912-1858OC. Epub 2010 Jun 3.
- Background: PubMed 21653528Crothers K, Thompson BW, Burkhardt K, Morris A, Flores SC, Diaz PT, Chaisson RE, Kirk GD, Rom WN, Huang L; Lung HIV Study. HIV-associated lung infections and complications in the era of combination antiretroviral therapy. Proc Am Thorac Soc. 2011 Jun;8(3):275-81. doi: 10.1513/pats.201009-059WR.
- Background: PubMed 23554932Gingo MR, Balasubramani GK, Kingsley L, Rinaldo CR Jr, Alden CB, Detels R, Greenblatt RM, Hessol NA, Holman S, Huang L, Kleerup EC, Phair J, Sutton SH, Seaberg EC, Margolick JB, Wisniewski SR, Morris A. The impact of HAART on the respiratory complications of HIV infection: longitudinal trends in the MACS and WIHS cohorts. PLoS One. 2013;8(3):e58812. doi: 10.1371/journal.pone.0058812. Epub 2013 Mar 12.
- Background: PubMed 16691060Grubb JR, Moorman AC, Baker RK, Masur H. The changing spectrum of pulmonary disease in patients with HIV infection on antiretroviral therapy. AIDS. 2006 May 12;20(8):1095-107. doi: 10.1097/01.aids.0000226949.64600.f9. No abstract available.
- Background: PubMed 19601771Llibre JM, Falco V, Tural C, Negredo E, Pineda JA, Munoz J, Ortega E, Videla S, Sirera G, Martinez E, Miralles C, Iribarren J, Galindo MJ, Domingo P, d'Arminio-Monforte A, Miro JM, Clotet B. The changing face of HIV/AIDS in treated patients. Curr HIV Res. 2009 Jul;7(4):365-77. doi: 10.2174/157016209788680633.
- Background: PubMed 20851926Crothers K, Huang L, Goulet JL, Goetz MB, Brown ST, Rodriguez-Barradas MC, Oursler KK, Rimland D, Gibert CL, Butt AA, Justice AC. HIV infection and risk for incident pulmonary diseases in the combination antiretroviral therapy era. Am J Respir Crit Care Med. 2011 Feb 1;183(3):388-95. doi: 10.1164/rccm.201006-0836OC. Epub 2010 Sep 17.
- Background: PubMed 22617340Akinbami LJ, Moorman JE, Bailey C, Zahran HS, King M, Johnson CA, Liu X. Trends in asthma prevalence, health care use, and mortality in the United States, 2001-2010. NCHS Data Brief. 2012 May;(94):1-8.
- Background: PubMed 21430629Moorman JE, Zahran H, Truman BI, Molla MT; Centers for Disease Control and Prevention (CDC). Current asthma prevalence - United States, 2006-2008. MMWR Suppl. 2011 Jan 14;60(1):84-6. No abstract available.
- Background: PubMed 24884738Gingo MR, Balasubramani GK, Rice TB, Kingsley L, Kleerup EC, Detels R, Seaberg EC, Greenblatt RM, Holman S, Huang L, Sutton SH, Bertolet M, Morris A. Pulmonary symptoms and diagnoses are associated with HIV in the MACS and WIHS cohorts. BMC Pulm Med. 2014 Apr 30;14:75. doi: 10.1186/1471-2466-14-75.
- Individual participant dataSharing planned: Undecided
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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.
Alison Morris, MD, MS principal investigator
University of Pittsburgh
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 University of Pittsburgh 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 2 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 13 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?
Adverse interaction of adiposity and HIV-associated inflammation in asthma susceptibility and airway remodeling in HIV (time frame: Baseline). 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 NCT02975258, which also lists 120 linked publications.
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 13 Oct 2017.