Aerosol Deposition in Asthmatic Obese Women Using Heliox

Sponsor
Jacqueline de Melo Barcelar (Other)
Overall Status
Completed
CT.gov ID
NCT02620956
Collaborator
(none)
20
1
2
2
10

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: nebulizing with heliox and oxygen
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Aerosol Deposition in Asthmatic Obese Women Using Heliox: A Randomized, Crossover, Controlled Clinical Trial Study
Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: obese nebulizer

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.

Experimental: asthmatic obese nebulizer

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.

Outcome Measures

Primary Outcome Measures

  1. Aerosol deposition in pulmonary compartments [two days]

Secondary Outcome Measures

  1. Aerosol deposition in vertical and horizontal gradient [two days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital the Federal University of Pernambuco Recife Pernambuco Brazil 50740560

Sponsors and Collaborators

  • Jacqueline de Melo Barcelar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jacqueline de Melo Barcelar, principal investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT02620956
Other Study ID Numbers:
  • 669.576.484-00
First Posted:
Dec 3, 2015
Last Update Posted:
Sep 15, 2016
Last Verified:
Sep 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 15, 2016