Chronic Obstructive Pulmonary Disease Moderate, Obesity
Conditions
Keywords
aerosol therapy, pulmonary scintigraphy, upper airways anatomy, High Flow Nasal Cannula
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.
Interventions
RADIATIONinhalation 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
DEVICEHigh 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.
Sponsors
Universidade Federal do Rio Grande do Norte
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pattern of aerosol lung deposition. | during the following 25 minutes post inhalation protocol | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper airways anatomical variables CT scans | first day of study | Upper airways anatomical variables will be measured by CT scans. |
| Mallampati Score | first day of study | Mallampati Score (from 1 to 4) |
| Change of pulmonary function after bronchodilators administration. (with and without HFNC) | Change from Baseline Pulmonary Function at 5 minutes after scintigraphy. | 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. |
| Muscle Mass | first day of study | Muscle Mass percentage |
| Body fat | first day of study | Body fat percentage |
| BMI | first day of study | Body mass index |
Countries
Brazil
Outcome results
None listed