Aerosol Therapy in Obese COPD Patients.

Universidade Federal do Rio Grande do Norte50 enrolled

Overview

This study has the objective to clarify the factors that directly influence the effectiveness of inhaled drug deposition in obese patients with chronic obstructive pulmonary disease (COPD) and then formulate specific strategies to control the evolution of this disease. The suggested strategy in order to implement the aerosol therapy is the use of High Flow Nasal Cannula (HFNC) during these patient´s inhalation therapy. It will consist in a cross-over clinical trial. The population will be composed by volunteers of both genders, aged between 45-70 years old. Four distinct groups will be formed: obese participants without copd; obese participants with copd; non obese participants without copd; non-obese participants with copd.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease Moderate Obesity

Interventions

inhalation protocolRADIATION

technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution

High Flow Nasal CannulaDEVICE

aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula will deliver the aerosol at a 30L/min flow of oxigen.

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: HEALTHY, non obese * no history of respiratory disease * non smokers * self declared sedentary * Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted * Forced Vital capacity (FVC) equal or higher than 80% of predicted; * FEV1/FVC higher than 70% of predicted. * BMI lower than 30 kg/m2 HEALTHY, obese * no history of respiratory disease * non smokers * self declared sedentary * Forced expiratory volume at first second (FEV1) equal or higher than 80% of predicted * Forced Vital capacity (FVC) equal or higher than 80% of predicted * FEV1/FVC higher than 70% of predicted. * BMI equal or higher than 30 kg/m2 COPD participants, non obese * ex smokers * clinical stability (six previous weeks) * FEV1 lower than 80% of predicted. * FEV1/FVC lower than 70 % post bronchodilator. * No cardiopulmonary diseases (self declared) * BMI lower than 30 kg/m2 COPD participants, obese * ex smokers * clinical stability (six previous weeks) * FEV1 lower than 80% of predicted. * FEV1/FVC lower than 70 % post bronchodilator. * No cardiopulmonary diseases (self declared) * BMI equal or higher than 30 kg/m2 Exclusion Criteria: * Difficulty to understand verbal commands * exacerbations during the study period

Locations (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Outcomes

Primary Outcomes

Pattern of aerosol lung deposition.

The pattern of aerosol lung deposition will be compared between obese and non obese participants (with and without COPD) as well as between inhalation with HFNC and without HFNC

Time frame: during the following 25 minutes post inhalation protocol

Secondary Outcomes

Change of pulmonary function after bronchodilators administration. (with and without HFNC)

pulmonary function will be evaluated previously to the inhalation protocol. After the inhalation protocol, this measurement will be assessed again in order to check the effect of bronchodilator drug.

Time frame: Change from Baseline Pulmonary Function at 5 minutes after scintigraphy.

Upper airways anatomical variables CT scans

Upper airways anatomical variables will be measured by CT scans.