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Clinical Trials/CTRI/2010/091/001496
CTRI/2010/091/001496
Completed
Phase 3

Evaluation of efficacy and safety of two bronchodilators for the treatment of bronchial asthma: a randomized, open label, active controlled, multicentric study.

Sun Pharmaceutical Industries Ltd., Acme Plaza, Andheri Kurla Road, Andheri East, Mumbai ? 400059. Maharashtra. India.0 sites200 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Sun Pharmaceutical Industries Ltd., Acme Plaza, Andheri Kurla Road, Andheri East, Mumbai ? 400059. Maharashtra. India.
Enrollment
200
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Sun Pharmaceutical Industries Ltd., Acme Plaza, Andheri Kurla Road, Andheri East, Mumbai ? 400059. Maharashtra. India.

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients aged between 18 and 65 years.
  • 2\. Patients diagnosed with bronchial asthma.
  • 3\. Patients willing to give informed consent.

Exclusion Criteria

  • 1\. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
  • 2\. Patients with suspected hypersensitivity and/or contraindication to the study medication or rescue medications.
  • 3\. Patients suffering from lung disease other than asthma.
  • 4\. Patients with history of non\-compliance to medical regimens or those patients unwilling to comply with the study protocol.
  • 5\. Patients with any severe illness like liver insufficiency, active hepatitis, known infection with HIV etc.
  • 6\. Patients who have been hospitalized for asthma within three month before the study.
  • 7\. Patients having any musculoskeletal, cardiovascular, or neurological condition or any other condition likely to adversely affect exercise performance or measurement of lung function.
  • 8\. Patients having disease like hyperthyroidism, heart disease and diabetes mellitus.

Outcomes

Primary Outcomes

Not specified

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