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Completed

NCT Number: NCT03031093

Aerosol Therapy in Obese COPD Patients.

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Upper airways anatomical variables CT scans

    Time frame: first day of study

    Upper airways anatomical variables will be measured by CT scans.

  3. Mallampati Score

    Time frame: first day of study

    Mallampati Score (from 1 to 4)

  4. BMI

    Time frame: first day of study

    Body mass index

  5. Muscle Mass

    Time frame: first day of study

    Muscle Mass percentage

  6. Body fat

    Time frame: first day of study

    Body fat percentage

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2017
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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