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Clinical Trials/CTRI/2023/10/058653
CTRI/2023/10/058653CompletedPhase 4

AN OPEN LABEL SINGLE ARM, MULTICENTRIC, PROSPECTIVE, POST MARKETING STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF FLUTICASONE FUROATE/ VILANTEROL (FF/VI) DPI IN THE MANAGEMENT OF ASTHMA PATIENTS (PROMISE OD) - NI

Glenmark Pharmaceuticals Ltd0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Inclusion Criteria

  • •1. Patients aged more than or equal to 12 years with a documented diagnosis of asthma
  • •2. Pre-bronchodilator FEV1 of 40-90% predicted normal
  • •3. Symptomatic patients receiving ongoing treatment with either ICS-SABA or ICS LABA or SMART
  • •4. ACQ-5 score more than or equal to 1.5 at baseline.
  • •5. Patient/parent/legal guardian willing to give a written informed consent/parental
  • •consent/assent form.
  • •6. Able to/Willing to strictly adhere to the investigator’s prescription

Exclusion Criteria

  • •1. History of current hospitalization with life threatening condition or patients with acute
  • •exacerbation of asthma (acute condition).
  • •2. Smoking history of more than 10 pack-years
  • •3. Women of childbearing potential are not restricted in this study, however it is expected
  • •that the investigator will assess the risks and benefits of the assigned treatment as per the
  • •product label(s) and discuss this with any women of childbearing potential prior to
  • •providing the patient with the prescription for the assigned treatment.
  • •4. Patients who have participated in any clinical trial within 30 days prior to enrolment and
  • •would not be participating in clinical study during the period of study participation.
  • •5. History of known hypersensitivity to any individual study drug of the study drug
  • •combination or to any of the excipient present in the dosage form.

Investigators

Sponsor
Glenmark Pharmaceuticals Ltd

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