Clinical trial NCT00900874: Rapid Onset Action of Salbutamol Versus Formoterol
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchial Asthma
Keywords: Formoterol
Rapid bronchodilation
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 78
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 asthma and no study that used it as rescue drug in children with acute exacerbation of asthma. The purpose of the present study is to evaluate whether the rapid bronchodilatory effect of formoterol is similar to that of salbutamol in children of 5-15 years with mild exacerbation of asthma.

Children will receive either salbutamol or formoterol by MDI. Participants will be explained about the study, spirometry and inhalation of medicine with MDI and spacer. Children will receive two puffs (100 microgram each of salbutamol) or Formoterol 2 puffs (6µg /puff) by MDI and spacer. Each child will be explained about the inhalation technique by using a MDI of placebo. After shaking the MDI it will be attached to spacer (700ml volume) and actuated. Child will be asked to take 5 tidal breaths. Another puff will be given by similar method.

Eligibility 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

Primary outcomes:
measure: Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes
timeFrame: 60 min
Secondary outcomes:
measure: Difference in average clinical asthma score between two groups
timeFrame: 60 min
measure: Adverse effects like tremors, vomiting, palpitation, etc, in two groups
timeFrame: 60 mins
measure: Number of patients requiring hospitalization in two groups at end of study period in two groups
timeFrame: 60 min
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIIMS
Study officials:
References:
citation: 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.