Aerosol Therapy in Obese COPD Patients.

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

Full Title of Study: “Aerosol Therapy With High Flow Nasal Cannula (HFNC) in Obese COPD Patients. Aerosol Deposition Pattern and Predictive Values.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: April 3, 2018

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

  • 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.

Arms, Groups and Cohorts

  • Experimental: Healthy, non obese + HFNC
    • 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).
  • Active Comparator: Healthy, non obese
    • 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).
  • Experimental: COPD, non obese + HFNC
    • 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).
  • Active Comparator: COPD, non obese
    • 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).
  • Experimental: healthy, obese + HFNC
    • 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).
  • Active Comparator: healthy, obese
    • 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).
  • Experimental: COPD, obese + HFNC
    • 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).
  • Active Comparator: COPD, obese
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • Pattern of aerosol lung deposition.
    • Time Frame: 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 Measures

  • Change of pulmonary function after bronchodilators administration. (with and without HFNC)
    • Time Frame: 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.
  • Upper airways anatomical variables CT scans
    • Time Frame: first day of study
    • Upper airways anatomical variables will be measured by CT scans.
  • Mallampati Score
    • Time Frame: first day of study
    • Mallampati Score (from 1 to 4)
  • BMI
    • Time Frame: first day of study
    • Body mass index
  • Muscle Mass
    • Time Frame: first day of study
    • Muscle Mass percentage
  • Body fat
    • Time Frame: first day of study
    • Body fat percentage

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universidade Federal do Rio Grande do Norte
  • Provider of Information About this Clinical Study
    • Principal Investigator: Taciano Dias de Souza Rocha, Master in Physiotherapy – Universidade Federal do Rio Grande do Norte
  • Overall Official(s)
    • Armele Dornelas de Andrade, PhD, Study Director, Universidade Federal de Pernambuco

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