Aerosol Deposition in Asthmatic Obese Women Using Heliox

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Obese
• Intervention / Treatment: Other: nebulizing with heliox and oxygen

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740560
      • Hospital the Federal University of Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Aerosol deposition in pulmonary compartments	two days

Secondary Outcome Measures

Outcome Measure	Time Frame
Aerosol deposition in vertical and horizontal gradient	two days

Collaborators and Investigators

• Sponsor: Jacqueline de Melo Barcelar

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (ESTIMATE): December 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 15, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Obesity; Asthma
• Other Study ID Numbers: 669.576.484-00