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Clinical Trials/CTRI/2024/08/073060
CTRI/2024/08/073060
Completed
Post Marketing Surveillance

A Multi-Centric, Active Post Marketing Surveillance Study to Assess the Safety and Efficacy of Fluticasone Furoate and Vilanterol Powder for Inhalation for the Treatment of Patients with Asthma

Sun Pharma Laboratories Limited19 sites in 1 country325 target enrollmentStarted: September 7, 2024Last updated:
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Overview

Phase
Post Marketing Surveillance
Status
Completed
Enrollment
325
Locations
19
Primary Endpoint
1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This will be a multi-centric, active post marketing surveillance to assess the safety and efficacy of Fluticasone Furoate and Vilanterol Powder for Inhalation (200 mcg/ 25 mcg) for the Treatment of Patients with Asthma in adults and adolescents. Approximately, 325 patients will be enrolled in the surveillance from various parts of India. Treatment will be administered for 12 weeks as per treating physician’s discretion based on prescribing information. Surveillance duration of all patients will be 24 weeks and surveillance data on safety and efficacy will be collected for a duration of 24 weeks.

Study Design

Study Type
Pms
Allocation
Na
Masking
None

Eligibility Criteria

Ages
12.00 Year(s) to 84.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patients of either gender, aged between greater than or equal to 12 to lesser than or equal to 84 years
  • •Patients with confirmed diagnosis of asthma at least 12 weeks prior to enrollment of the surveillance
  • •Patients with asthma where use of a combination medicinal product [long-acting beta2-agonist (LABA) and inhaled corticosteroid (ICS)] is appropriate in opinion of treating physician based on prescribing information (PI) and inadequately controlled on combination of low to medium dose ICS and LABA
  • •Patients/Legally acceptable representatives (LAR) are willing to provide informed consent (and assent for patients aged greater than or equal to 12 years and lesser than 18 years) to collect the surveillance data.

Exclusion Criteria

  • •Exclusion of patients from surveillance will be done as per below listed criteria and prescribing information:
  • •Patients with history of intolerance or hypersensitivity to any of the components of Fluticasone Furoate and Vilanterol Powder for Inhalation
  • •Patient with history of moderate to severe hepatic impairment, cardiac arrhythmias, pulmonary tuberculosis, and ocular disorder (such as cataract, glaucoma etc.)
  • •Patient with any clinically significant disorder that, in the opinion of the treating physician would result in jeopardizing patient safety or his/ her inability to understand and comply with the requirements of the surveillance
  • •Pregnant women and nursing mothers.

Outcomes

Primary Outcomes

1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs)

Time Frame: Throughout the study period

Secondary Outcomes

  • 1. Change from Baseline in forced expiratory volume in 1 second (FEV1)(Baseline, Weeks 4, 8 and 12)
  • 2. Change from Baseline in forced vital capacity (FVC)(Baseline, Weeks 4, 8 and 12)

Investigators

Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Pravin Ghadge

Sun Pharma Laboratories Limited

Study Sites (19)

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