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 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

试验速览

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•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

•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.

发起方

Glenmark Pharmaceuticals Ltd