NCT01012050

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

November 11, 2009

Status Verified

November 1, 2009

Enrollment Period

7 months

First QC Date

April 22, 2009

Last Update Submit

November 10, 2009

Conditions

Asthma

Keywords

Asthmastatus asthmatics

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary characteristics

    6 months

Secondary Outcomes (1)

  • Radioaerosol pulmonary index, radioaerosol penetration index and pulmonary clearance.

    6 months

Study Arms (2)

NV Group

EXPERIMENTAL

Performed nebulization coupled with noninvasive ventilation

Device: NV

NEB group

ACTIVE COMPARATOR

Performed nebulization alone.

Other: NEB group

Interventions

NVDEVICE

Noninvasive ventilation coupled with nebulization(Nebulization containing salbutamol (2.5mg) and ipratropium bromide (0.25mg)plus oxygen flow in 7Lpm)

Also known as: Interventional Group
NV Group
NEB groupOTHER

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

Also known as: Control group
NEB group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valdecir Castor Galindo Filho

Recife, Pernambuco, Brazil

Location

Related Publications (4)

  • Soroksky A, Stav D, Shpirer I. A pilot prospective, randomized, placebo-controlled trial of bilevel positive airway pressure in acute asthmatic attack. Chest. 2003 Apr;123(4):1018-25. doi: 10.1378/chest.123.4.1018.

    PMID: 12684289BACKGROUND

  • Franca EE, Dornelas de Andrade AF, Cabral G, Almeida Filho P, Silva KC, Galindo Filho VC, Marinho PE, Lemos A, Parreira VF. Nebulization associated with bi-level noninvasive ventilation: analysis of pulmonary radioaerosol deposition. Respir Med. 2006 Apr;100(4):721-8. doi: 10.1016/j.rmed.2005.07.012. Epub 2005 Aug 31.

    PMID: 16139491BACKGROUND

  • Soma T, Hino M, Kida K, Kudoh S. A prospective and randomized study for improvement of acute asthma by non-invasive positive pressure ventilation (NPPV). Intern Med. 2008;47(6):493-501. doi: 10.2169/internalmedicine.47.0429. Epub 2008 Mar 17.

    PMID: 18344635BACKGROUND

  • Galindo-Filho VC, Brandao DC, Ferreira Rde C, Menezes MJ, Almeida-Filho P, Parreira VF, Silva TN, Rodrigues-Machado Mda G, Dean E, Dornelas de Andrade A. Noninvasive ventilation coupled with nebulization during asthma crises: a randomized controlled trial. Respir Care. 2013 Feb;58(2):241-9. doi: 10.4187/respcare.01371.

    PMID: 22781558DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Valdecir C Galindo

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 22, 2009

First Posted

November 11, 2009

Study Start

June 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 11, 2009

Record last verified: 2009-11

Locations

BR(1)