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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01012050
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : November 11, 2009
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Universidade Federal de Pernambuco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Device: NV Other: NEB group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysing the Effects of Coupling Nebulization to Noninvasive Ventilation Through Pulmonary Scintigraphy on the Radioaerosol Deposition During Asthma Exacerbation
Study Start Date : June 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: Control group

Primary Outcome Measures :
  1. Cardiopulmonary characteristics [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance. [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01012050

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Valdecir Castor Galindo Filho
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Universidade Federal de Pernambuco
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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Principal Investigator: Valdecir C Galindo Universidade Federal de Pernambuco
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Valdecir Castor Galindo Filho, Universidade Federal de Pernambuco Identifier: NCT01012050    
Other Study ID Numbers: VNI1972NEB
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009
Keywords provided by Universidade Federal de Pernambuco:
status asthmatics
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases