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

This study has been completed.

Sponsor:

Collaborator:

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Information provided by:

Universidade Federal de Pernambuco

ClinicalTrials.gov Identifier:

NCT01012050

First received: April 22, 2009

Last updated: November 10, 2009

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 22, 2009

Last Updated Date

November 10, 2009

Start Date ^ICMJE

June 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cardiopulmonary characteristics [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01012050 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Radioaerosol Pulmonary Deposition During Asthma Exacerbation Through Noninvasive Ventilation

Official Title ^ICMJE

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

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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
Other: NEB group
Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm

Other Name: Control group

Study Arm (s)

Experimental: NV Group
Performed nebulization coupled with noninvasive ventilation

Intervention: Device: NV
Active Comparator: NEB group
Performed nebulization alone.

Intervention: Other: NEB group

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01012050

Other Study ID Numbers ^ICMJE

VNI1972NEB

Has Data Monitoring Committee

Yes

Responsible Party

Valdecir Castor Galindo Filho, Universidade Federal de Pernambuco

Study Sponsor ^ICMJE

Universidade Federal de Pernambuco

Collaborators ^ICMJE

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators ^ICMJE

Principal Investigator:

Valdecir C Galindo

Universidade Federal de Pernambuco

Information Provided By

Universidade Federal de Pernambuco

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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