Rapid Onset Action of Salbutamol Versus Formoterol
Comparing Rapid Bronchodilatory Effect of Formoterol and Salbutamol in Children Between 5-15 Years With Mild to Moderate Acute Exacerbation of Asthma- A Double Blind Randomized Controlled Trial
1 other identifier
interventional
78
1 country
1
Brief Summary
The hypothesis of this study is that the onset of rapid bronchodilatory effect of inhaled Formoterol (12 microgram) is comparable to that of inhaled salbutamol (200 microgram) i.e., the difference in mean forced expiratory volume in 1 second (FEV1) between the 2 groups at 1, 5, 10, 30 and 60 minutes will be less than 10% in children between 5-15 years with mild acute exacerbation of asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 12, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 13, 2009
May 1, 2009
1.3 years
May 12, 2009
May 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes
60 min
Secondary Outcomes (3)
Difference in average clinical asthma score between two groups
60 min
Adverse effects like tremors, vomiting, palpitation, etc, in two groups
60 mins
Number of patients requiring hospitalization in two groups at end of study period in two groups
60 min
Study Arms (2)
1
ACTIVE COMPARATORSalbutamol + steroid
2
ACTIVE COMPARATORFormoterol + steroid
Interventions
Eligibility Criteria
You may qualify if:
- Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD
- Mild exacerbation will be defined as:
- children presenting with increase in symptoms (cough, wheeze, breathlessness) for less than 7 days duration
- no chest indrawing
- no difficulty in speech
- clinical asthma score (or pulmonary index score-annexure 1) between 6-9
You may not qualify if:
- Children with life threatening asthma detected by presence of any of the following:
- severe chest indrawing
- cyanosis
- irregular respiration
- altered sensorium
- Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma
- If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol)
- Child not able to perform spirometry
- Parents refusing to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIIMS
New Delhi, New Delhi, 110029, India
Related Publications (1)
Arun JJ, Lodha R, Kabra SK. Bronchodilatory effect of inhaled budesonide/formoterol and budesonide/salbutamol in acute asthma: a double-blind, randomized controlled trial. BMC Pediatr. 2012 Mar 7;12:21. doi: 10.1186/1471-2431-12-21.
PMID: 22394648DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 12, 2009
First Posted
May 13, 2009
Study Start
January 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
May 13, 2009
Record last verified: 2009-05