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Randomized controlled parallel arm clinical trial comparing the effectiveness, safety, cost and acceptability of salbutamol aerosol inhaler and salbutamol tablet in the management of acute exacerbation of asthma in children

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SLCTR Registration Number

SLCTR/2014/012

Date of Registration

20 Jun 2014

The date of last modification

Mar 03, 2019

Trial Status


Application Summary

Scientific Title of Trial

Randomized controlled parallel arm clinical trial comparing the effectiveness, safety, cost and acceptability of salbutamol aerosol inhaler and salbutamol tablet in the management of acute exacerbation of asthma in children

Public Title of Trial

Comparing the effectiveness, safety, cost and acceptability of salbutamol aerosol inhaler and salbutamol tablet in the treatment of asthma in children

Disease or Health Condition(s) Studied

Asthma

Scientific Acronym

None

Public Acronym

None

Brief title

Salbutamol MDI and Spacer vs. Salbutamol tablet for children with asthma

Universal Trial Number

U1111-1157-0497

Any other number(s) assigned to the trial and issuing authority

ERC/14/09 (SLMA)


Trial Details

What is the research question being addressed?

Is the percentage of children with mild and moderate acute asthma exacerbation successfully treated with salbutamol metered dose inhaler + spacer 10% greater than the percentage of children successfully treated with salbutamol tablet?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Single blinded

Control

Active

Assignment

Parallel

Purpose

Treatment

Study Phase

Phase 4

Intervention(s) planned

Arm 1: Salbutamol metered dose inhalation aerosol (100 microgram/ puff, delivered via spacer device) at the dose of 200 microgram administered 8 hourly at 8 am, 2 pm and 8 pm for 3 days* (9 doses). Since it is generally not issued by the Hospital Pharmacy, the research team will be buying a single preparation of the aerosol and the spacer device. Parents and child will be trained by one of the investigators about inhaler technique.

Arm 2: Salbutamol tablet (2 mg or 4 mg) at the dose of 2 mg administered 8 hourly at 8 am, 2 pm, 8 pm for 3 days* (9 doses). Preparation which is available in the Hospital Pharmacy during the study period will be used.

Inclusion criteria

  1. Clinical diagnosis of acute exacerbation of asthma (see below for case definition)
  2. Ages between 6-12 years
  3. Receiving in-ward treatment
  4. Children who require regular salbutamol in the treatment of acute exacerbation of asthma. This includes
    a. Children with severe / moderate acute asthma exacerbation who would be put on regular salbutamol after initial treatment with nebulized salbutamol and other medications
    b. Children with mild/moderate asthma who would be straightaway put on regular salbutamol

  5. Not used any form of inhaled medications previously
  6. Not on nebulized salbutamol at the time of enrollment
  7. Not on any other bronchodilators at the time of enrollment

    Case definition of "Clinically diagnosed to have Bronchial asthma acute exacerbation"
  8. Previously diagnosed with bronchial asthma (at least one episode with written evidence)
  9. Presenting with progressively increasing episodes of shortness of breath, cough, wheeze or chest tightness or combination of these symptoms
  10. Presence of bilateral rhonchi on auscultation of lungs

Exclusion criteria

  1. Children having long term co-morbidities
  2. Children on long term co-medications
  3. Children/ parents who cannot be trained to use inhalers for one reason or other

Primary outcome(s)

1.

Percentage of children successfully treated children within 3 days. Successful treatment: will be objectively determined using “Pulmonary Score” (a validated score)

 [

The blinded outcome assessor (BOA) will be assessing each participant:
twice a day when the child is on the intervention and whenever required (maximum duration 3 days)

]

Secondary outcome(s)

1.
  1. Mean duration taken for successful treatment in children responded in 3 days or less
  2. Number of children requiring nebulized salbutamol and/ or other bronchodilators during the trial period(they will be considered as non-successfully treated)
  3. Duration of hospital stay (related to treatment of asthma)
  4. Changes in Peak Expiratory Flow Rate
  5. Adverse effects of salbutamol
  6. Cost of salbutamol treatment
  7. Days taken to return to school
  8. Recurrence of symptoms of asthma exacerbations within 2 weeks of stopping the treatment
    1. Revisits to hospitals/ GP within two weeks of discharge with symptoms of asthma exacerbation
  9. Acceptability, convenience and suitability of intervention
 [

Outcomes 1-5: The blinded outcome assessor (BOA) will be assessing each participant twice a day when the child is on the intervention and whenever required (maximum duration 3 days) -using the follow up questionnaire and adverse reaction check list

Outcome 6: Will be assessed at the end of the trial

Outcome 7: 2-3 days after discharge, by telephone interview

Outcomes 8, 9: 2 weeks after discharge by telephone interview

Outcome 10: Day of discharge (by self administered questionnaire to mother/carer)

]

Target number/sample size

112 for each arm. The sample size was calculated using a non-inferiority criterion. The formula used was designed for hypothesis testing of non-inferiority trials when outcome measure is dichotomous variable. Using the Formula and a pilot study data, the

Countries of recruitment

Sri Lanka

Anticipated start date

2014-07-01

Anticipated end date

2015-06-30

Date of first enrollment

2014-07-01

Date of study completion

Recruitment status

Recruiting

Funding source

None

Regulatory approvals


State of Ethics Review Approval

Status

Approved

Date of Approval

2014-05-23

Approval number

ERC/14/09

Details of Ethics Review Committee

Name: Ethics Review Committee, Sri Lanka Medical Association
Institutional Address:No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka
Telephone:+94-11-2693324
Email: erc.slma@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr Shalini Sri Ranganathan (PI)
Professor in Pharmacology and Consultant Paediatrician
Department of Pharmacology Faculty of Medicine, University of Colombo Po Box 271, Kynsey Road Colombo 8 Sri Lanka
+94 (0) 112695300. Ext 198
+ 94 (0) 714927165
+ 94 (0) 112697483
sshalini14@hotmail.com

Contact Person for Public Queries

Dr Saman Abeyawardana (Co-PI)
Consultant Paediatrician, Embillipitiya Base Hospital
Embillipitiya Base Hospital Embillipitiya
+ 94 (0) 47 2 23026
+ 94 (0) 767929914, + 94 (0) 777929914

samanabeyawardana@yahoo.com

Primary study sponsor/organization

Base Hospital Embilipitiya

Hospital Road, Embilipitiya Sri Lanka
+ 94 (0) 47 2 23026


Secondary study sponsor (If any)

None





Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

No

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results


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