Rapid Onset Action of Salbutamol Versus Formoterol

• Status: Unknown status
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: Albuterol; Formoterol Fumarate

Criteria

Inclusion Criteria:

1. Children aged 5-15 years of either sex seeking treatment with mild exacerbation of asthma in pediatric chest clinic or Pediatric OPD

2. 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 Criteria:

1. Children with life threatening asthma detected by presence of any of the following:

• severe chest indrawing

• cyanosis

• irregular respiration

• altered sensorium

2. Children with other chronic respiratory conditions like tuberculosis, cystic fibrosis or other acute illness that would complicate current treatment and response for asthma

3. If child has taken salbutamol in last 6 hours or if he is on long acting beta agonists (formoterol or salmeterol)

4. Child not able to perform spirometry

5. Parents refusing to give consent