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Aerosol Deposition in Asthmatic Obese Women Using Heliox

Aerosol Deposition in Asthmatic Obese Women Using Heliox: A Randomized, Crossover, Controlled Clinical Trial Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02620956
Enrollment
20
Registered
2015-12-03
Start date
2015-11-30
Completion date
2016-01-31
Last updated
2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Obese

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.

Interventions

OTHERnebulizing 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.

Sponsors

Jacqueline de Melo Barcelar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frame
Aerosol deposition in pulmonary compartmentstwo days

Secondary

MeasureTime frame
Aerosol deposition in vertical and horizontal gradienttwo days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026