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Clinical Trials/CTRI/2009/091/001041
CTRI/2009/091/001041CompletedPhase 3

?A CONTROLED LABELED, DOUBLE ARM, RANDOMIZED, MULTI- CENTRIC, PROSPECTIVE PHASE III CLINICAL TRIAL TO COMPARE EFFICACY AND SAFETY OF FIXED DOSE COMBINATION OF DOXOPHYLLINE 800 mg SR AND MONTELUKAST 10 mg WITH DOXOPHYLLINE 800mg SR IN SUBJECTS SUFFERING WITH ACUTE BRONCHOSPASM OF DIFFERENT ETIOLOGY?

Swiss Garnier Life SciencesNo. 68A, Vembuli Amman koli St, Alandur, Chennai 600016 .Phone : 044-22329837, 223128920 sites150 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
150
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •Patients of either sex of age >= 18 and <= 70 years.
  • •Patient suffering from mild to moderate bronchospasm of different etiology.
  • •PEF between 50% to 80 % (mild to moderate)by using Peak flow meter.
  • •Pre menopausal women must use the appropriate contraception.
  • •Patient willing to give informed consent.

Exclusion Criteria

  • •Patients with significant pulmonary insufficiency, including both intrinsic lung disease and Respiratory failure i.e. severe bronchospasm
  • •Patient with a history of known hypersensitivity from any one of the said medication.
  • •Patients with acute myocardial infarction, hypotension.
  • •Patients with uncontrolled hypertension.
  • •Bronchospasm of anaphylactic, mechanical or cancerous origin.
  • •Subjects with severe hepatic, renal failure or encephalopathy.
  • •Chronic alcoholics.
  • •Patients with history of cardiac surgery.
  • •Pregnant & lactating women.

Investigators

Sponsor
Swiss Garnier Life SciencesNo. 68A, Vembuli Amman koli St, Alandur, Chennai 600016 .Phone : 044-22329837, 22312892

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