Clinical trial NCT03031093: Aerosol Therapy in Obese COPD Patients.
Official title: Aerosol Therapy With High Flow Nasal Cannula (HFNC) in Obese COPD Patients. Aerosol Deposition Pattern and Predictive Values.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Moderate
Obesity
Keywords: aerosol therapy
pulmonary scintigraphy
upper airways anatomy
High Flow Nasal Cannula
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pattern of aerosol lung deposition.
timeFrame: during the following 25 minutes post inhalation protocol
Secondary outcomes:
measure: Change of pulmonary function after bronchodilators administration. (with and without HFNC)
timeFrame: Change from Baseline Pulmonary Function at 5 minutes after scintigraphy.
measure: Upper airways anatomical variables CT scans
timeFrame: first day of study
measure: Mallampati Score
timeFrame: first day of study
measure: BMI
timeFrame: first day of study
measure: Muscle Mass
timeFrame: first day of study
measure: Body fat
timeFrame: first day of study
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Armele Dornelas de Andrade, PhD
role: STUDY_DIRECTOR
References:
citation: Rocha T, Rattes C, Morais C, Souza R, Rolim N, Brandao S, Fink JB, Dornelas de Andrade A. Predictive anatomical factors of lung aerosol deposition in obese individuals. Would modified mallampati score be relevant? Clinical trial. Respir Med. 2020 Sep;171:106083. doi: 10.1016/j.rmed.2020.106083. Epub 2020 Jul 12.