A Phase 2 interventional study of nebulizing with heliox and oxygen in Obese and Asthma, sponsored by Jacqueline de Melo Barcelar. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-15.
Sponsored by Jacqueline de Melo Barcelar · Phase 2, Interventional, and Treatment
BACKGROUND: The aim of this study was to assess pulmonary deposition and distribution of radio-aerosol in obese and normal women, using 2-D planar scintigraphy. METHODS: after inhaling an aerosol of technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA) with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler.
BACKGROUND: Obese asthmatics are difficult to treat effectively, worse asthma control, and do not respond as well to standard therapy as lean asthmatic. Medical aerosols an important route of drug delivery in asthma, but narrowing in the airway cause by the obesity, can provoke turbulence and the effectiveness of the treatment could be compromise.
AIM: To assess pulmonary deposition, distribution of radio-aerosol and analyze upper way dimension in obese and normal weight women, using 2-D planar scintigraphyand and computed tomography. METHODS: 20 obese women, 10 asthmatics and 10 non-asthmatics took part of the first part of the study. Anthropometric and clinical assessments were carried out, than lung function was performed. After randomization of the sequence of gas (sequence 1- oxygen and heliox; sequence 2-heliox and heliox) that would be used to inhale an aerosol with technetium labeled diethylenetriamine penteacetic acid (99mTc - DTPA) with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml using a vibrating mesh inhaler. All patients inhaled two times with one week of washout between then to eliminate risk of residual trace radiation and to avoid the possibility of bias.
6,578 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 20 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with Jacqueline de Melo Barcelar as lead sponsor.
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Exclusion Criteria:
would be used to inhale an aerosol with technetium labeled diethylenetriaminepente-acetic acid (99mTc - DTPA) with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml and heliox using a vibrating mesh inhaler.
Other: nebulizing with heliox and oxygen
would be used to inhale an aerosol with technetium labeled diethylenetriaminepente-acetic acid (99mTc - DTPA) with an activity of 1 mCi in a total dose volume with normal saline of 2,5 ml and heliox using a vibrating mesh inhaler.
Other: nebulizing with heliox and oxygen
Mesh Nebulizer with heliox and oxygen. In order to determine the sequence of the gas associated with the inhaled a randomization was performed, sequence 1- first oxygen and second heliox (80:20) or sequence 2- first heliox (80:20) and secondy oxygen.
Aerosol deposition in pulmonary compartments
Time frame: two days
Aerosol deposition in vertical and horizontal gradient
Time frame: two days
The record gives a start of Nov 2015, a primary completion of Dec 2015 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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