Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000816853
Ethics application status
Approved
Date submitted
30/07/2012
Date registered
3/08/2012
Date last updated
3/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Role of a drug called Montelukast, in acute asthma attack
Scientific title
A Randomized, double-blind, placebo-controlled trial to assess the effects of Oral Montelukast on forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR) in patients with acute asthma exacerbation
Secondary ID [1] 280921 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Not applicable
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute asthma 287003 0
Condition category
Condition code
Respiratory 287338 287338 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the treatment arm 1 will receive oral montelukast 10 mg first dose in the ER followed by 10 mg oral dose once a day in evening for the duration of stay in the hospital
Intervention code [1] 285356 0
Treatment: Drugs
Comparator / control treatment
Patients in the treatment arm 2 will get the placebo that will be of the same appearance (color and size) and taste as the trial medication; it will be prepared by the Hilton Pharma after being approved by Ministry of Health (MoH) Pakistan. The first dose to be given in the ER followed by once daily for a period of duration of stay in the hospital
Control group
Placebo

Outcomes
Primary outcome [1] 287620 0
Primary Outcome 1:Improvement in FEV1
Timepoint [1] 287620 0
Bedside spirometry to be done on admission and discharge using PiKo-1 (ATS and EU electronic peak flow monitor, Ferraris Respiratory Europe Ltd., Westford SG13 7NW, UK) software which measures the PEFR and FEV1. The PiKo-1 test to be repeated three times
Primary outcome [2] 287622 0
Primary Outcome 2:Improvement in PEFR
Timepoint [2] 287622 0
Serial peak expiratory flow rate (PEFR) monitoring;
a baseline PEFR value to be obtained on enrolment,
then at 30, 60 and 90 minutes from the baseline value, followed by every 12 hours daily until discharge.
A minimum of 3 readings to be obtained each time before administration of bronchodilator and the best of 3 to be taken as the final value.
Secondary outcome [1] 298544 0
Secondary Outcome 1:Development of complications such as respiratory failure, cardiac arrest and/or death
Timepoint [1] 298544 0
Assessment of secondary outcomes to be done throughout the duration of hospital stay after initiation of therapy with oral montelukast sodium

Eligibility
Key inclusion criteria
All adults (age 16 and above), presenting to the ER or clinic of Aga Khan University Hospital (AKUH) with acute asthma exacerbation will be eligible for the study. They will be included if they have one or more features suggestive of ‘Acute asthma exacerbation’ according to GINA Guidelines and are hospitalized

Acute asthma exacerbation is characterized by a progressive increase in shortness of breath, cough, wheezing or chest tightness, and by a decrease in expiratory flow that can be quantified by simple measures of pulmonary function such as PEFR and FEV1. The severity of exacerbations may range from mild to life-threatening.
Hospital admission criteria will be standardized:
a.FEV1 < 70% predicted or PEFR < 300 L/min after receiving initial treatment in the emergency room
b.Respiratory rate > 24 breaths/min
c.No improvement in symptoms like shortness of breath or wheezing
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Under 16 years of age
2.Pregnancy
3.Patients who do not consent to participate
4.History of tobacco use > 10 pack years
5.Any acute concurrent medical condition like pneumonia, congestive heart failure or pneumothorax on presentation to the ER
6.Concomitant therapy with systemic corticosteroids or le ukotriene modifiers at time of admission
7.FEV1 > 70% predicted or PEFR > 300 L/min
8. Acute respiratory failure requiring mechanical ventilation
9.Patients initially recruited in the study but improved after initial treatment and discharged from the ER

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All adults (age 16 and above) coming to the emergency room or outpatient clinic of Aga Khan University Hospital for acute asthma exacerbation will be evaluated by the on-call Pulmonary resident / Senior medicine resident on Pulmonary rotation

The purpose and methods of the study will be explained to him/her and consent will be obtained in writing. The patient will then be randomly allocated to either treatment group.

The study has two arms:
ARM 1: Standard therapy + Montelukast
ARM 2: Standard therapy + Placebo
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This would be a double-blinded study; neither the patient nor the doctor will know the treatment status of the patient. The AKUH pharmacy will play a pivotal role in randomization of patients. The trial coordinator at AKUH pharmacy will be the key person to maintain randomization and blinding and will be the only one to know the treatment status of the patient. As soon as a patient is enrolled in the trial, a message will be sent to the pharmacy, which will issue a code number and allot the patient to one of the treatment groups.

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) was used for randomization and Excel sheet was used to generate random numbers as per sample size
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4445 0
Pakistan
State/province [1] 4445 0
Sindh

Funding & Sponsors
Funding source category [1] 285713 0
Commercial sector/Industry
Name [1] 285713 0
Hilton Pharma (Pvt.) Limited
Country [1] 285713 0
Pakistan
Primary sponsor type
Commercial sector/Industry
Name
Hilton Pharma (Pvt.) Limited
Address
8th floor,
Prograssive Plaza,
Beaumont road,
Karachi, 75530
Country
Pakistan
Secondary sponsor category [1] 284563 0
University
Name [1] 284563 0
Aga Khan University
Address [1] 284563 0
Stadium Road,
P.O. Box 3500
Karachi, 74800
Country [1] 284563 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287721 0
Ethical Review Committee (ERC)
Ethics committee address [1] 287721 0
Ethics committee country [1] 287721 0
Pakistan
Date submitted for ethics approval [1] 287721 0
Approval date [1] 287721 0
16/12/2004
Ethics approval number [1] 287721 0
375-Med/ERC-04

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34492 0
Address 34492 0
Country 34492 0
Phone 34492 0
Fax 34492 0
Email 34492 0
Contact person for public queries
Name 17739 0
Ali Bin Sarwar Zubairi
Address 17739 0
Section of Pulmonary and Critical Care Medicine
Department of Medicine
Aga Khan University Hospital
Stadium Road, P.O. Box 3500
Karachi, 74800
Country 17739 0
Pakistan
Phone 17739 0
+92 21 3486 4685
Fax 17739 0
+92 21 3493 4294
Email 17739 0
ali.zubairi@aku.edu
Contact person for scientific queries
Name 8667 0
Ali Bin Sarwar Zubairi
Address 8667 0
Section of Pulmonary and Critical Care Medicine
Department of Medicine
Aga Khan University Hospital
Stadium Road, P.O. Box 3500
Karachi, 74800
Country 8667 0
Pakistan
Phone 8667 0
+92 21 3486 4685
Fax 8667 0
+92 21 3493 4294
Email 8667 0
ali.zubairi@aku.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.