Status:
UNKNOWN
Rapid Onset Action of Salbutamol Versus Formoterol
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Bronchial Asthma
Eligibility:
All Genders
5-15 years
Phase:
PHASE4
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 ...
Detailed Description
It is desirable to have a single MDI that can be used as both LABA and SABA. There are few studies involving few children on use of formoterol that shows rapid bronchodilatation in children with asthm...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00900874
Start Date
January 1 2009
End Date
May 1 2010
Last Update
May 13 2009
Active Locations (1)
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1
AIIMS
New Delhi, New Delhi, India, 110029