Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation (NV)

November 10, 2009 updated by: Universidade Federal de Pernambuco

Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation

Despite the physiologic and clinical effects provided by coupling nebulization with noninvasive ventilation in asthma exacerbation, there are few and controversial studies reported in the literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Reduced work of breathing, increased oxygenation and increased in expiratory peak flow (EPF) and forced expiratory volume in the first second (FEV1) are benefits of noninvasive ventilation (NV) in the treatment of asthma. Despite these clinical improvements attributed to NV during asthma exacerbations and the well-established effects of nebulization, there are few studies in the literature coupling both therapeutic resources.

In addition to this, no studies on scintigraphic analysis of radioaerosol deposition coupled with NV in asthmatics have published. A previous study was published by our group, but involved healthy subjects.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Valdecir Castor Galindo Filho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe asthma (FEV1 < 60 % of predicted values)
  • Breathing rate > 25 bpm
  • History of asthma for at least 1 year
  • Duration of current asthma attack of < 7 days
  • Reversibility of FEV1 of at least ≤ 10% after the administration of bronchodilator drugs

Exclusion Criteria:

  • Current smoker
  • Presence of cardiopulmonary disease (COPD, pneumonia, heart failure, myocardial infarction, pneumothorax)
  • Hyperthermia
  • Indication of intubation and invasive mechanical ventilation;
  • Hemodynamic instability (heart rate > 150 bpm and systolic blood pressure < 90 mmHg)
  • Cardiac arrhythmia
  • Changes in consciousness
  • Pregnancy
  • Contraindications to use NV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NV Group
Performed nebulization coupled with noninvasive ventilation
Device: NV
Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm)
Other Names:
  • Interventional Group
Active Comparator: NEB group
Performed nebulization alone.
Other: NEB group
Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiopulmonary characteristics
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

  • Principal Investigator: Valdecir C Galindo, Universidade Federal de Pernambuco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

November 11, 2009

Last Update Submitted That Met QC Criteria

November 10, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNI1972NEB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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