NCT01403467

Brief Summary

This current study aimed to demonstrate the effectiveness of the addition of CPAP to the current conventional therapy in terms of airway obstruction improvement in acute asthma patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2011

Completed
Last Updated

July 27, 2011

Status Verified

December 1, 2010

Enrollment Period

9 months

First QC Date

July 25, 2011

Last Update Submit

July 26, 2011

Conditions

Acute Asthma

Keywords

Bronchial diseaseasthmacontinuous positive airway pressure (CPAP)Bronchoconstriction

Outcome Measures

Primary Outcomes (1)

  • an improvement in PEFR, as % predicted

    75 mins

Study Arms (1)

NIPPV

EXPERIMENTAL
Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressureDEVICE

CPAP 8 cmH2O

Also known as: GoodKnight 420 G; Nellcor Puritan Bennett Inc.
NIPPV

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged over 18 years
  • known asthmatic patients visiting ED with acute exacerbation
  • had given their written informed consent.

You may not qualify if:

  • smoking history
  • chronic obstructive pulmonary disease
  • required intubation
  • instability of hemodynamic or arrhythmia
  • unable to perform PEFR
  • facial abnormality
  • pulmonary infiltration
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Bronchial DiseasesAsthma

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Yuda Sutherasan, M.D.

    Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 27, 2011

Study Start

April 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2011

Last Updated

July 27, 2011

Record last verified: 2010-12

Locations

TH(1)