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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 18:00:12 GMT) CTRI Number CTRI/2016/10/007382 [Registered on: 18/10/2016] - Trial Registered Retrospectively Last Modified On 22/08/2015 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Placebo Controlled Trial Public Title of Study Comparison of oral montelukast with oral ozagrel in sudden attack of asthma Scientific Title of Comparison of oral montelukast with oral ozagrel in acute asthma – A prospective, randomized, Study double blinded study. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Vyshak U S Trial Coordinator (multi-center study) Designation Junior resident Affiliation kasturba medical college manipal Address department of pulmonary medicine,kasturba medical college manipal,manipal university department of pulmonary medicine,kasturba medical college manipal,manipal university Udupi KARNATAKA 576104 India Phone 9986948061 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Rahul Magazine Query) Designation professor and unit 2 head Affiliation kasturba medical college manipal Address Department of Pulmonary Medicine,Kasturba Medical College Manipal, University Manipal Udupi KARNATAKA 576104 India Phone 9901727204 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Rahul Magazine Designation professor and unit 2 head Affiliation kasturba medical college manipal Address Department of Pulmonary Medicine,Kasturba Medical College Manipal, University Manipal Udupi KARNATAKA 576104 India page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 9901727204 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Kasturba Medical College Manipal, manipal university manipal,Udupi Krnataka Primary Sponsor Primary Sponsor Details Name Dr vyshak U S Address Department of Pulmonary Medicine Kasturba Medical College Manipal University Manipal Udupi District Karnataka 576104 Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Vyshak U S kasturba medical P ward, 4th 9986948061 college floor,Department of Pulmonary Medicine, vyshusurendra1303@g Kasturba Medical mail.com College Manipal University Manipal Udupi KARNATAKA Udupi KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 14/10/2014 No Committee, Kasturba Hospital, Manipal Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Acute exacerbation of Bronchial Asthma Intervention / Type Name Details Comparator Agent Intervention Montelukast Patients in the montelukast arm will be given oral Montelukast 10 mg tablet at enrollment and a placebo tablet after 12 hours,in addition to the standard treatment for asthma exacerbation from the day of admission till the day of discharge. Intervention Ozagrel Patients in ozagrel group will be given oral ozagrel 200 mg tablet one at enrollment and one tablet after 12 hours, in addition to the standard treatment for asthma exacerbation from the day of admission till the day of discharge. page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Comparator Agent Placebo Patients in the placebo arm will be given neither montelukast nor ozagrel. They will be given the standard treatment of asthma exacerbation alone. Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1.Age between 18 and 65.<br/> 2.Previously diagnosed case of bronchial asthma.<br/> 3.A primary diagnosis of acute exacerbation of asthma on presentation.<br/> 4.Peak expiratory flow rate (PEFR)less than or equal to 75% of personal best with in the last 12 months or of predicted value.<br/> 5.No other acute pathology complicating the present condition like cardiac,metabolic or other respiratory causes. Exclusion Criteria Exclusion Criteria Details 1.Smoking history more than 10 pack years. 2.Pregnant females and Breast feeding females. 3.Patient on regular Leukotriene receptor antagonists or thromboxane A2 synthetase inhibitor with in 2 weeks of presentation. 4.Intake of oral or parenteral steroids for > 5 days with in one month of presentation. 5.Intake of theophylline with in one week of presentation. 6.Need of intubation before presentation. 7.Patients on regular Rifampicin, Phenytoin or Phenobarbitone. 8. History of allergy to Montelukast or ozagrel. 9. Baseline renal function test and liver function test derangement. Method of Generating Permuted block randomization, variable Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints Percentage change in PEFR (Peak expiratory 6 hrs 12 hrs 24 hrs and 48 hrs following flow rate)from baseline. administration of study drug and at discharge. Secondary Outcome Outcome Timepoints Number of times rescue medications were Any time from the administration of study drug to required. the time of discharge. Target Sample Size Total Sample Size=120 Sample Size from India=120 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 2/ Phase 3 Date of First 23/10/2014 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Trial (India) Publication Details Brief Summary This study is performed to identify whether adding an oral leukotriene antagonist and oral thromboxane A2 synthetase inhibitor to the standard prescribed treatment of acute asthma, would further produce improvement in patients on standard treatment.Informed written consent will be taken from the patients in the language understandable to them. Patients presenting to outpatient unit or emergency triage from october 2014 to March 2016 with a primary diagnosis of acute exacerbation of asthma requiring hospitalisation, will be included in the study if they meet the inclusion criteria. The enrolled patients will have a baseline measurement of PEFR made using a mini Wright’s PEF meter. After 5 minutes of baseline PEFR, the patients will be randomised into three groups. The investigator will exercise no control over the randomisation process. Patients in all the three groups will receive standard treatment for asthma exacerbation i.e., Nebulised Salbutamol 2.5 mg 6th hourly, Nebulised Ipratropium bromide 500 mcg 6th hourly and intravenous Methyl prednisolone 40 mg 8th hourly. Patients randomised to Group1 will in addition to standard treatment receive an oral Montelukast 10 mg tablet at enrolment and a placebo tablet after 12 hours. Patients randomised to Group 2 will receive an oral ozagrel 200 mg tablet one at enrolment and one tablet after 12 hours. Patients randomised to Group 3 will receive placebo tablets one at enrolment and a tablet after 12 hours. The investigational medications will be continued till the patient has been discharged the hospital or develops any adverse effects to these drugs. Rescue medication - Nebulised Salbutamol will be given on need basis. Additional oxygen and methylxanthines will be given if indicated. PEFR values, rescue medication details and vitals (Pulse rate, Blood pressure, Respiratory rate and SaO2/ pulse oximetry) will be recorded after 6 hours, 12 hours, 24 hours and 48 hours of drug or placebo administration and at discharge. Additional recording of these parameters will be done in the morning (8 am - 10 am) following admission. Findings of history, physical examination and laboratory investigations will be noted and entered as per the proforma. The primary endpoint will be the absolute change from baseline in PEFR at each measured time point following treatment. Secondary end point will be need for rescue medications.Data will be analyzed using repeated measures ANOVA and chi square test. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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