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Trial record 94 of 150 for:    Ipratropium OR atrovent

The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room

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ClinicalTrials.gov Identifier: NCT01524198
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : February 13, 2014
Last Update Posted : March 13, 2014
Sponsor:
Collaborator:
King Fahad Medical City
Information provided by (Responsible Party):
AAlangari, King Saud University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Status Asthmaticus
Interventions Drug: Budesonide
Drug: Normal saline
Enrollment 945
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Normal Saline, Albuterol, Ipratropium Bromide Budesonide, Albuterol, Ipratropium Bromide
Hide Arm/Group Description Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
Period Title: Overall Study
Started 471 474
Completed 448 458
Not Completed 23 16
Reason Not Completed
Protocol Violation             8             6
Withdrawal by Subject             15             10
Arm/Group Title Normal Saline, Albuterol, Ipratropium Bromide Budesonide, Albuterol, Ipratropium Bromide Total
Hide Arm/Group Description Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back Total of all reporting groups
Overall Number of Baseline Participants 448 458 906
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 448 participants 458 participants 906 participants
<=18 years
448
 100.0%
458
 100.0%
906
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 448 participants 458 participants 906 participants
Female
161
  35.9%
156
  34.1%
317
  35.0%
Male
287
  64.1%
302
  65.9%
589
  65.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Saudi Arabia Number Analyzed 448 participants 458 participants 906 participants
448 458 906
1.Primary Outcome
Title Patients Hospitalization Rate
Hide Description The number of patients hospitalized over the study period (17 months).
Time Frame 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline, Albuterol, Ipratropium Bromide Budesonide, Albuterol, Ipratropium Bromide
Hide Arm/Group Description:
Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
Overall Number of Participants Analyzed 448 458
Measure Type: Number
Unit of Measure: participants
82 75
2.Secondary Outcome
Title Change in Asthma Score From Baseline as Compared to the Score at Disposition
Hide Description A negative change of asthma score from baseline measurement to measurement at disposition, which could be at 2, 3, or 4 hours time points would indicate a decrese in asthma severity. The asthma score ranged between 5 and 15 points as in the protocol, where 5 is the mildest and 15 is the most severe.
Time Frame 2, 3, or 4 hours from baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline, Albuterol, Ipratropium Bromide Budesonide, Albuterol, Ipratropium Bromide
Hide Arm/Group Description:
Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
Overall Number of Participants Analyzed 448 458
Mean (Standard Deviation)
Unit of Measure: units on asthma score
-4.58  (2.33) -4.77  (2.31)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Normal Saline, Albuterol, Ipratropium Bromide Budesonide, Albuterol, Ipratropium Bromide
Hide Arm/Group Description Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
All-Cause Mortality
Normal Saline, Albuterol, Ipratropium Bromide Budesonide, Albuterol, Ipratropium Bromide
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Normal Saline, Albuterol, Ipratropium Bromide Budesonide, Albuterol, Ipratropium Bromide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/448 (0.00%)      0/458 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Normal Saline, Albuterol, Ipratropium Bromide Budesonide, Albuterol, Ipratropium Bromide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/448 (3.35%)      13/458 (2.84%)    
Cardiac disorders     
Palpitation *  5/448 (1.12%)  5 6/458 (1.31%)  6
Nervous system disorders     
Fine tremor *  10/448 (2.23%)  10 7/458 (1.53%)  7
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Abdullah Alangari
Organization: King Saud University
Phone: 966506287276
EMail: alangari100@gmail.com
Layout table for additonal information
Responsible Party: AAlangari, King Saud University
ClinicalTrials.gov Identifier: NCT01524198     History of Changes
Other Study ID Numbers: 08-MED520-02
First Submitted: January 30, 2012
First Posted: February 1, 2012
Results First Submitted: November 2, 2013
Results First Posted: February 13, 2014
Last Update Posted: March 13, 2014