Aerosol Deposition in Asthmatic Obese Women Using Heliox
Primary Purpose
Obese, Asthma
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
nebulizing with heliox and oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Obese
Eligibility Criteria
Inclusion Criteria:
- Were women with Body mass Index (BMI) ≥30kg/m2 for obese and BMI =18.5 - 24.9 kg/m2 for the control group
- Age between 18 to 60 years old
- With and without moderate to severe asthma
- Positive response to bronchodilator (improvement in FEV1 and/or FVC of at least 12% and 200ml).
Exclusion Criteria:
- Were women with active pulmonary disease other than asthma
- Neuromuscular diseases
- Smokers and those incapable of performing procedures were excluded.
Sites / Locations
- Hospital the Federal University of Pernambuco
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
obese nebulizer
asthmatic obese nebulizer
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Aerosol deposition in pulmonary compartments
Secondary Outcome Measures
Aerosol deposition in vertical and horizontal gradient
Full Information
NCT ID
NCT02620956
First Posted
December 1, 2015
Last Updated
September 14, 2016
Sponsor
Jacqueline de Melo Barcelar
1. Study Identification
Unique Protocol Identification Number
NCT02620956
Brief Title
Aerosol Deposition in Asthmatic Obese Women Using Heliox
Official Title
Aerosol Deposition in Asthmatic Obese Women Using Heliox: A Randomized, Crossover, Controlled Clinical Trial Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacqueline de Melo Barcelar
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
obese nebulizer
Arm Type
Active Comparator
Arm Description
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.
Arm Title
asthmatic obese nebulizer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
nebulizing with heliox and oxygen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Aerosol deposition in pulmonary compartments
Time Frame
two days
Secondary Outcome Measure Information:
Title
Aerosol deposition in vertical and horizontal gradient
Time Frame
two days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Were women with Body mass Index (BMI) ≥30kg/m2 for obese and BMI =18.5 - 24.9 kg/m2 for the control group
Age between 18 to 60 years old
With and without moderate to severe asthma
Positive response to bronchodilator (improvement in FEV1 and/or FVC of at least 12% and 200ml).
Exclusion Criteria:
Were women with active pulmonary disease other than asthma
Neuromuscular diseases
Smokers and those incapable of performing procedures were excluded.
Facility Information:
Facility Name
Hospital the Federal University of Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740560
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
15625820
Citation
Darquenne C, Prisk GK. Aerosol deposition in the human respiratory tract breathing air and 80:20 heliox. J Aerosol Med. 2004 Fall;17(3):278-85. doi: 10.1089/jam.2004.17.278.
Results Reference
background
PubMed Identifier
16723037
Citation
Hess DR, Fink JB, Venkataraman ST, Kim IK, Myers TR, Tano BD. The history and physics of heliox. Respir Care. 2006 Jun;51(6):608-12.
Results Reference
background
PubMed Identifier
16723042
Citation
Fink JB. Opportunities and risks of using heliox in your clinical practice. Respir Care. 2006 Jun;51(6):651-60.
Results Reference
background
PubMed Identifier
11029371
Citation
Niimi A, Matsumoto H, Amitani R, Nakano Y, Mishima M, Minakuchi M, Nishimura K, Itoh H, Izumi T. Airway wall thickness in asthma assessed by computed tomography. Relation to clinical indices. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1518-23. doi: 10.1164/ajrccm.162.4.9909044.
Results Reference
background
Learn more about this trial
Aerosol Deposition in Asthmatic Obese Women Using Heliox
We'll reach out to this number within 24 hrs