Aerosol Deposition in Asthmatic Obese Women Using Heliox

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02620956
• Other study ID #: 669.576.484-00
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2015
• Last updated: September 14, 2016
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: September 2016
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Obese

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital the Federal University of Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Jacqueline de Melo Barcelar

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View Citation

Fink JB. Opportunities and risks of using heliox in your clinical practice. Respir Care. 2006 Jun;51(6):651-60. Review. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerosol deposition in pulmonary compartments		two days	No
Secondary	Aerosol deposition in vertical and horizontal gradient		two days	No