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Rapid Onset Action of Salbutamol Versus Formoterol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900874
Recruitment Status : Unknown
Verified May 2009 by All India Institute of Medical Sciences, New Delhi.
Recruitment status was:  Recruiting
First Posted : May 13, 2009
Last Update Posted : May 13, 2009
Information provided by:
All India Institute of Medical Sciences, New Delhi

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.

Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: salbutamol Drug: Formoterol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2009
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

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

Primary Outcome Measures :
  1. Difference in mean FEV1 between the two groups at 1, 5, 10, 30, 60 minutes [ Time Frame: 60 min ]

Secondary Outcome Measures :
  1. Difference in average clinical asthma score between two groups [ Time Frame: 60 min ]
  2. Adverse effects like tremors, vomiting, palpitation, etc, in two groups [ Time Frame: 60 mins ]
  3. Number of patients requiring hospitalization in two groups at end of study period in two groups [ Time Frame: 60 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00900874

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Contact: S.K Kabra, Dr 9868397540
Contact: Jenish Rajma 9868369498

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AIIMS Recruiting
New Delhi, India, 110029
Principal Investigator: Jenish Rajma         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: J.Jenish Rajma, AIIMS Identifier: NCT00900874     History of Changes
Other Study ID Numbers: AIIIMS
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: May 13, 2009
Last Verified: May 2009
Keywords provided by All India Institute of Medical Sciences, New Delhi:
Rapid bronchodilation
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents