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Completed

NCT Number: NCT01823926

Asthma and Quantifying Delivery Of Radio Labeled Aerosol

Introduction: Inhalation therapy has been established as an efficient route to treat asthma exacerbations, but coupled to noninvasive ventilation (NIV) remains quite challenging.

Objectives: The aim of this study were to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using vibrating mesh nebulizers (VMN) and jet nebulizer (JN) coupled to noninvasive ventilation (NIV).

Material and methods: The investigators assessed 10 stable moderate to severe asthmatics in a crossover study. Patients was randomly assigned to participate in both phases of the study: Phase 1(NIV+MN) and phase 2(NIV+JN). DTPA-Tc99m with radioactivity of 25 miC was used to inhaler using JN positioned in the circuit using a "T" piece, particle size generation in a five micron range and oxygen flow tritated at eight L/min and MN was positioned in the mask, particle size generation in a one range and connected to electrical energy. NIV was used a bilevel pressure through a face mask attached with straps and pressure adjusted were 12 cmH2O and 5 cmH2O as inspiratory and expiratory pressures, respectively. After, radioactivity counts were performed using a gama camera and regions of interest were delimited. To calculate aerosol mass balance the investigators considered the amount of radioaerosol deposited into the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory filters, and mask divided for each of these compartments and represented as a percentage.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • stable moderate to severe asthma (FEV1 > 60% and > 80% and PEF with a variation of 30% from the predicted values to moderate and FVE1 > 60% and );
  • More than one year elapsed since the diagnosis of asthma;
  • None exacerbation in the last six months;
  • Age between 18 - 60 years, from both sexes,
  • Able to understand verbal commands
  • Consent to participate in this protocol.

Exclusion criteria

  • presence of dyspnea;
  • smoking history;
  • cardiopulmonary diseases (chronic obstructive pulmonary disease, pneumonia, cardiac failure, myocardial infarction, pneumothorax);
  • hyperthermia;
  • hemodynamic instability (heart rate > 150 bpm and systolic blood pressure < 90 mmHg);
  • arrhythmia absence;
  • pregnancy
  • contraindications for use of noninvasive ventilation

Treatment and study plan

Noninvasive ventilation

Other

Bilevel positive pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure (França et al., 2006).

Jet Nebulizer

Device

Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a "T" piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min.

The vibrating mesh nebulizer (VMN)

Device

Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.

Primary outcomes

  1. To compare inhaled dose of radioaerosol into the lungs and determine distribution across horizontal and vertical gradients

    Time frame: 10 mouths

    Immediately after inhalation, participants sat in a chair with the back positioned in front to the gamma camera (STARCAM 3200 GE, California, USA) to obtain radioactives counts from the posterior thorax during a period of 500 seconds on a matrix of 256 X 256 matrix. After, participants were positioned sitting in front to the gama camera to obtain images from face. Then, the same procedure was performed to analysis deposition in the nebulizer, circuits, inspiratory filter, expiratory filter and face mask. Counts representing stomach were obtained from posterior thorax and corrections for decay of technetium were used to during extrapulmonary measurements.

Secondary outcomes

  1. To quantify mass balance of the delivery system and different compartments, including intrapulmonary and extrapulmonary deposition.

    Time frame: 10 mouths

    The analysis of deposition in pulmonary and extrapulmonary compartments was expressed as a percentage from the count in each compartment to the total radioaerosol mass generated by nebulizers. The inhaled radioaerosol was considered the sum of deposition into the upper airways, lungs and stomach.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

Quantifying Delivery Of Radio Labeled Aerosol During Noninvasive Ventilation To Stable Moderate And Severe Asthmatics: A Randomized, Cross-Over Clinical Trial

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Apr 4, 2013
Registry last updated
Apr 4, 2013

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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