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Rapid Onset Action of Salbutamol Versus Formoterol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00900874
First received: May 12, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 12, 2009
May 12, 2009
January 2009
May 2010   (final data collection date for primary outcome measure)
Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes [ Time Frame: 60 min ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Difference in average clinical asthma score between two groups [ Time Frame: 60 min ] [ Designated as safety issue: Yes ]
  • Adverse effects like tremors, vomiting, palpitation, etc, in two groups [ Time Frame: 60 mins ] [ Designated as safety issue: No ]
  • Number of patients requiring hospitalization in two groups at end of study period in two groups [ Time Frame: 60 min ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Bronchial Asthma
  • Drug: salbutamol
    two puffs (100 microgram each of salbutamol) by MDI and spacer
  • Drug: Formoterol
    Formoterol 2 puffs (6 µg /puff) by MDI and spacer
  • Active Comparator: 1
    Salbutamol + steroid
    Intervention: Drug: salbutamol
  • Active Comparator: 2
    Formoterol + steroid
    Intervention: Drug: Formoterol
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
5 Years to 15 Years
No
Contact: S.K Kabra, Dr 9868397540
Contact: Jenish Rajma 9868369498 jenish.rajma@gmail.com
India
 
NCT00900874
AIIIMS
Yes
J.Jenish Rajma, AIIMS
All India Institute of Medical Sciences, New Delhi
Not Provided
Not Provided
All India Institute of Medical Sciences, New Delhi
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP