Rapid Onset Action of Salbutamol Versus Formoterol

Bronchial Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00900874
• Other study ID #: AIIIMS
• Status: Recruiting
• Phase: Phase 4
• First received: May 12, 2009
• Last updated: May 12, 2009
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2009
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: S.K Kabra, Dr
• Phone: 9868397540
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• salbutamol
two puffs (100 microgram each of salbutamol) by MDI and spacer
• Formoterol
Formoterol 2 puffs (6 µg /puff) by MDI and spacer

Locations

Country	Name	City	State
India	AIIMS	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes		60 min	No
Secondary	Difference in average clinical asthma score between two groups		60 min	Yes
Secondary	Adverse effects like tremors, vomiting, palpitation, etc, in two groups		60 mins	No
Secondary	Number of patients requiring hospitalization in two groups at end of study period in two groups		60 min	No