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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy, non obese + HFNC | Experimental | Healthy, non obese participants will perform the following inhalation protocol: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 (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min). |
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| Healthy, non obese | Active Comparator | Healthy, non obese participants will perform the following inhalation protocol: 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 dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min). |
|
| COPD, non obese + HFNC | Experimental | non obese COPD participants will perform the following inhalation protocol: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 (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhalation protocol | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
HEALTHY, non obese
HEALTHY, obese
COPD participants, non obese
COPD participants, obese
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armele Dornelas de Andrade, PhD | Universidade Federal de Pernambuco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Pernambuco | Recife | Pernambuco | 50670-901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32917355 | Derived | 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| COPD, non obese | Active Comparator | non obese COPD participants will perform the following inhalation protocol: 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 dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min). |
|
| healthy, obese + HFNC | Experimental | Healthy obese participants will perform the following inhalation protocol: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 (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min). |
|
| healthy, obese | Active Comparator | Healthy obese participants will perform the following inhalation protocol: 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 dose volume 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland) with free flow. The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min). |
|
| COPD, obese + HFNC | Experimental | Obese COPD participants will perform the following inhalation protocol: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 (HFNC) with 30L/min flow will be used to deliver aerosol. Volunteer seated; Preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; HFNC; Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min). |
|
| COPD, obese | Active Comparator | Obese COPD participants will perform the following inhalation protocol: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). The volunteer will be positioned seated in a chair. A mouthpiece associated with a T-tube with Inspiratory and Expiratory branches will be positioned in his mouth for preliminary acclimatization (1-2 min). Inspiratory branch: source of oxygen; bag of air accumulation. Expiratory branch: filter (Vital signs, USA). Nebulization will run until the full dose has been used (3-4 min). |
|
| High Flow Nasal Cannula | Device | 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. |
|
| Upper airways anatomical variables CT scans | Upper airways anatomical variables will be measured by CT scans. | first day of study |
| Mallampati Score | Mallampati Score (from 1 to 4) | first day of study |
| BMI | Body mass index | first day of study |
| Muscle Mass | Muscle Mass percentage | first day of study |
| Body fat | Body fat percentage | first day of study |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |