CTRI/2024/08/073060 [Registered on: 29/08/2024] Trial Registered Prospectively
Last Modified On:
05/02/2025
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Safety and Efficacy of Fluticasone Furoate and Vilanterol Powder in the treatment of Patients with Asthma
Scientific Title of Study
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
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/23/PMS/001, Version No. 2.0, Dated 27.04.2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
AVP and Head_India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Shruti Saha
Designation
Manager_Clinical Science_ Medical Affairs & Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
shruti.saha@sunpharma.com
Details of Contact Person Public Query
Name
Digambar Tornale
Designation
Manager 2_India Clinical Research_Medical Affairs & Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Digambar.Tornale@sunpharma.com
Source of Monetary or Material Support
Sun Pharma Laboratories Limited
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Sun Pharma Laboratories Limited
Sun Pharma Advanced Research Centre (SPARC), Tandalja, Vadodara -390012, Gujarat, India
Jaipur National University Institute for Medical Sciences and Research Centre
Department pf respiratory, Ground floor, OPD – room no. 02, Near New RTO Office, Jagatpura, Jaipur, 302017, Rajasthan, India Jaipur RAJASTHAN
7060924809
drrahulguptajnu@gmail.com
Dr Piyush Arora
Jawahar Lal Nehru Medical College
OPD no 6, Ground Floor, Department of Pulmonology, Kal Bagh, Ajmer-305001, Rajasthan, India. Ajmer RAJASTHAN
9887088122
doctor.piyusharora@gmail.com
Dr Sarat Kumar Behera
Kanungo Institute of Diabetes Specialties
Department of TB & Chest, 1st floor (OPD room), 1120 Dumduma Bhubaneshwar Khordha Orissa-751019. Khordha ORISSA
9438554039
drsarat2010@rediffmail.com
Dr Valluri Satyaprasad
King George Hospital
Clinical Research Room, Department of General Medicine, Rajendra Prasad ward, Andhra Medical college, Maharanipeta Visakhapatnam, 530002, Andhra Pradesh, India. Visakhapatnam ANDHRA PRADESH
9393104578
drsatyaprasadresearch@gmail.com
Dr Gaurav Ghatawat Bhanwarlal
Lion Tarachand Bapa Hospital and Research Centre
Out Patient Department, Room No 5, C.U Shah Complex Lion Tarachand Bapa Marg, Jian Society, Sion (W) Mumbai Maharashtra -400022 Mumbai (Suburban) MAHARASHTRA
9930628439
gaurav_ghatwat@yahoo.co.in1
Dr Jaydip Deb
Nil Ratan Sircar Medical College and Hospital
Department of Chest and Respiratory Medicine, 138, AJC Bose Road, Kolkata 700014 WB, India. Kolkata WEST BENGAL
Room No.2, Ground Floor, Dept of Medicine, Dehu- Moshi Rd, Moshi, Pimpari- Chinchwad, Maharashtra-412105 Pune MAHARASHTRA
9962257627
dnyandeep007@gmail.com
Dr Ajit Singh
SMS Hospital
F-1, Division of allergy and Pulmonary Medicine Dhanvantri OPD Block SMS Hospital Jaipur-302004. Jaipur RAJASTHAN
9829135692
dr.ajeetsingh@yahoo.com
Dr Pratibha Gupta
Venkateshwar Hospital
Department of Respiratory medicine, SECTOR 18A Dwarka Delhi (India) – 110075 South West DELHI
9891170363
Pratibha_gupta3@yahoo.com
Dr Kunjir Nana Gokul
Vishwaraj Hospital
Department of Pulmonology, Ground floor, OPD no. 04, Gate no 499, Kadamvakvasti, Solapur road, Loni kalbhor, Pune Maharashtra-412201, India. Pune MAHARASHTRA
Fluticasone Furoate and Vilanterol Powder for Inhalation (200 mcg + 25 mcg).
Capsules are to be used through Octahaler for inhalation once daily for 12 weeks treatment duration. Capsules are not to be swallowed, crushed or chewed. Capsules are to be used at the same time every day. Capsules are not to be used more than 1 time every 24 hours.
Comparator Agent
NA
NA
Inclusion Criteria
Age From
12.00 Year(s)
Age To
84.00 Year(s)
Gender
Both
Details
1. Patients of either gender, aged between greater than or equal to 12 to lesser than or equal to 84 years
2. Patients with confirmed diagnosis of asthma at least 12 weeks prior to enrollment of the surveillance
3. 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
4. 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
ExclusionCriteria
Details
Exclusion of patients from surveillance will be done as per below listed criteria and prescribing information:
1. Patients with history of intolerance or hypersensitivity to any of the components of Fluticasone Furoate and Vilanterol Powder for Inhalation
2. Patient with history of moderate to severe hepatic impairment, cardiac arrhythmias, pulmonary tuberculosis, and ocular disorder (such as cataract, glaucoma etc.)
3. 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
4. Pregnant women and nursing mothers
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs)
Throughout the study period
Secondary Outcome
Outcome
TimePoints
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
Target Sample Size
Total Sample Size="325" Sample Size from India="325" Final Enrollment numbers achieved (Total)= "325" Final Enrollment numbers achieved (India)="325"
Phase of Trial
Post Marketing Surveillance
Date of First Enrollment (India)
07/09/2024
Date of Study Completion (India)
Date Missing
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global)
Completed
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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.