CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 102 enrolled
Drug / intervention
Blood draw +7 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02975258
NCT02975258N/ACompleted

Adiposity and Airway Inflammation in HIV-Associated Airway Disease

University of Pittsburgh·observational·Posted Nov 29, 2016·Updated Oct 13, 2017

In Brief

An observational study evaluating Blood draw, Questionnaires, and 6 other interventions for Asthma and 2 related conditions. Completed, enrolled 102 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, HIV, Adiposity
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 29, 2016
Enrollment StartSep 1, 2015
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.6 years ago

Interventions

Blood drawprocedure

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

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

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

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

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

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

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.