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

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.

Study Overview

• Status: Unknown
• Conditions: Bronchial Asthma
• Intervention / Treatment: Drug: salbutamol; Drug: Formoterol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • New Delhi, India, 110029
    • Recruiting
    • AIIMS
    • Principal Investigator: Jenish Rajma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Salbutamol + steroid	Drug: salbutamol; two puffs (100 microgram each of salbutamol) by MDI and spacer
Active Comparator: 2; Formoterol + steroid	Drug: Formoterol; Formoterol 2 puffs (6 µg /puff) by MDI and spacer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes	60 min

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Anticipated): May 1, 2010
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: May 12, 2009
• First Submitted That Met QC Criteria: May 12, 2009
• First Posted (Estimate): May 13, 2009

Study Record Updates

• Last Update Posted (Estimate): May 13, 2009
• Last Update Submitted That Met QC Criteria: May 12, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Formoterol; Rapid bronchodilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Formoterol Fumarate
• Other Study ID Numbers: AIIIMS