Aerosol Therapy in Obese COPD Patients.

Obesity Clinical Trial

Official title:

Aerosol Therapy With High Flow Nasal Cannula (HFNC) in Obese COPD Patients. Aerosol Deposition Pattern and Predictive Values.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031093
• Other study ID #: CAAE: 57946516.0.0000.5537
• Status: Completed
• Phase: N/A
• Start date: December 2, 2017
• Est. completion date: May 5, 2018

Study information

• Verified date: October 2019
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 suggest the use of High Flow Nasal Cannula (HFNC) during their inhalation therapy.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 5, 2018
• Est. primary completion date: April 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Moderate
• Lung Diseases, Obstructive
• Obesity
• Pulmonary Disease, Chronic Obstructive

Intervention

Radiation:
• inhalation protocol
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

Device:
• High Flow Nasal Cannula
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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during the following 25 minutes post inhalation protocol
Secondary	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.	Change from Baseline Pulmonary Function at 5 minutes after scintigraphy.
Secondary	Upper airways anatomical variables CT scans	Upper airways anatomical variables will be measured by CT scans.	first day of study
Secondary	Mallampati Score	Mallampati Score (from 1 to 4)	first day of study
Secondary	BMI	Body mass index	first day of study
Secondary	Muscle Mass	Muscle Mass percentage	first day of study
Secondary	Body fat	Body fat percentage	first day of study