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Comparison of oral montelukastwith oral ozagrel in sudden attack of asthma

Phase 2
Conditions
Health Condition 1: null- Acute exacerbation of Bronchial Asthma
Registration Number
CTRI/2016/10/007382
Lead Sponsor
Dr vyshak U S
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

1.Age between 18 and 65.

2.Previously diagnosed case of bronchial asthma.

3.A primary diagnosis of acute exacerbation of asthma on presentation.

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.

5.No other acute pathology complicating the present condition like cardiac,metabolic or other respiratory causes.

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage change in PEFR (Peak expiratory flow rate)from baseline.Timepoint: 6 hrs 12 hrs 24 hrs and 48 hrs following administration of study drug and at discharge.
Secondary Outcome Measures
NameTimeMethod
umber of times rescue medications were required.Timepoint: Any time from the administration of study drug to the time of discharge.
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