A clinical study to evaluate the Efficacy and safety of Generic Fluticasone Propionate Inhalation Aerosol (pMDI, HFA 134a) in patients with Bronchial Asthma.
Scientific Title of Study
A Prospective, Multi-center, Randomized, Assessor-blind, Parallel-group, Comparative Clinical Endpoint Bioequivalence Study to Compare the Efficacy and Safety of Generic Fluticasone Propionate Inhalation Aerosol (pMDI, HFA 134a) (test drug) (of Macleods Pharmaceuticals Ltd) versus the Reference Listed Drug FLOVENT HFA (pMDI) Inhalation Aerosol and Efficacy and Safety of both Test and RLD to a Placebo-control in Treatment of Patients with Bronchial Asthma.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CT-007-FLPR-2017, Version 5.0;dated 04-Dec-2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ashish Mungantiwar
Designation
Executive-Medical Services, Head Clinical Trial
Affiliation
Macleods Pharmaceuticals Ltd
Address
Macleods Pharmaceuticals Ltd.
R&D III Plot no 18,street no. 09, Marol,MIDC,Andheri (East)
Mumbai (Suburban) MAHARASHTRA 400093 India
Phone
02248890100
Fax
02229256229
Email
drashish@macleodspharma.com
Details of Contact Person Scientific Query
Name
Dr Ashish Mungantiwar
Designation
Executive-Medical Services, Head Clinical Trial
Affiliation
Macleods Pharmaceuticals Ltd
Address
Macleods Pharmaceuticals Ltd.
R&D III Plot no 18,street no. 09, Marol,MIDC,Andheri (East)
Mumbai (Suburban) MAHARASHTRA 400093 India
Phone
02248890100
Fax
02229256229
Email
drashish@macleodspharma.com
Details of Contact Person Public Query
Name
Dr Ashish Mungantiwar
Designation
Executive-Medical Services, Head Clinical Trial
Affiliation
Macleods Pharmaceuticals Ltd
Address
Macleods Pharmaceuticals Ltd.
R&D III Plot no 18,street no. 09, Marol,MIDC,Andheri (East)
Mumbai (Suburban) MAHARASHTRA 400093 India
Phone
02248890100
Fax
02229256229
Email
drashish@macleodspharma.com
Source of Monetary or Material Support
MACLEODS PHARMACEUTICALS LTD
Primary Sponsor
Name
MACLEODS PHARMACEUTICALS LTD
Address
MACLEODS PHARMACEUTICALS LTD.
R & D III, Plot No. 18, street No. 9, Marol, MIDC, Andheri-(East), Mumbai 400 093, India.
Tel.: 91-22-48890100
BGS Global Institute of Medical Sciences and Hospital
BGS Global Institute of Medical Sciences and Hospital, No 67, BGS Health and Education city, Uttarahali Road, Kengeri, Bengaluru 560060, Karnataka India Bangalore KARNATAKA
Criticare Hospital & Research Institute, 4th Floor, Dhanshree Complex, Near Hotel Hardeo, Sitabuldi, Nagpur 440012, Maharashtra, India Nagpur MAHARASHTRA
0712-2522281 - vivekurvashi@yahoo.co.in
Dr Swapnav Borthakur
Down town Hospital
Dispur,G S Road,Guwahati-781006, Assam India Kamrup ASSAM
Dr.D.Y.Patil Medical College, Hospital & Research Center
Dept. of Respiratory Medicine, Dr.D.Y.Patil Medical College, Hospital & Reaserch Centre, Pimpri, Pune-411018, Maharashtra, India Pune MAHARASHTRA
020-27805944 - bagrechamahavir7@gmail.com
Dr Tapaswi Krishna Patibandla
Gleneagles Global Hospitals
Gleneagles Global
Hospitals
6-1-1070/1 to
4, Lakdikapul,
Hyderabad, Telangana
500004
Hyderabad TELANGANA
040-23244444 040-23240010 dottykrishna@yahoo.com
Dr Diyya Sudheer
Government Fever Hospital
Department of pulmonary medicine, Government fever Hospital, Gorantla Guntur 522034 Guntur ANDHRA PRADESH
863-2244026
dsudheer.dr@gmail.com
Dr Priti L Meshram
Grant Govt. Medical College& Sir JJ Group of Hospital
Grant Govt. Medical College & Sir JJ Group of hospital, JJ Marg, Byculla, Mumbai- 400 008, Maharashtra, India
Mumbai MAHARASHTRA
022-23735555
drpritimeshram@gmail.com
Dr Jayesh Shah
Hi-Tech Multispeciality Hospital
Room No. 4, Ground Floor, Sector 3-D, Plot No. 1180, Near Gh-11/2 Bus Stand, Gandhinagar, Gujarat - 382003, India Gandhinagar GUJARAT
079-23240555
drjayesh.shah10@gmail.com
Dr Srikanth Krishnamurthy
Hindustan Hospital
Hindustan Hospital,
522/3, 523/3 Nava India
Road,
Udaiyampalayam,
Coimbatore – 641028,
Tamil Nadu, India
Coimbatore
TAMIL NADU Coimbatore TAMIL NADU
0422-4327777
drsrikanthcbe@gmail.com
Dr Shreehas Bardapurkar
Ishwar Institute of Health care
Ishwar Institute of Health care, Ishwar Heights, 1st floor, Plot No.7, Gut No.6/1,Beside Punjabi bhavan, Mumbai Nashik Highway,Padegaon,Aurnagabad-431002, Maharashtra Aurangabad MAHARASHTRA
0240-23777140
sbardapurkar@gmail.com
Dr Ranjith V
K.R. Hospital, Mysore Medical college & research institute
Department of
medicine, K.R. Hospital,
Mysore Medical college
& research institute,
Irwin road, Mysuru570001, Karnataka,
India
Mysore
KARNATAKAepartment of
medicine, K.R. Hospital,
Mysore Medical college
& research institute,
Irwin road, Mysuru570001, Karnataka,
India
Mysore
KARNATAKA Mysore KARNATAKA
0821-2420101
ranjithvmmcri@gmail.com
Dr Jitendrakumar Anand
Kanoria Hospital and Research Centre
Kanoria Hospital and Research Centre
Airport Gandhinagar Highway, Village Bhat
Dist- Gandhinagar, Gujarat- 382428.
Gandhinagar GUJARAT
079-23969274
jkanand09@gmail.com
Dr Vishak Acharya K
Kasturba Medical College & Hospital
Department of
Pulmonary Medicine
Kasturba Medical
College & Hospital
Attavar Mangalore
575001 Karnataka India
Dakshina Kannada
KARNATAKA Dakshina Kannada KARNATAKA
0824-2445858
achvish@yahoo.co.in
Dr Ashish Nikhare
Lata Mangeshkar Multispeciality Hospital
Lata Mangeshkar Multispeciality Hospital
Dept. of Pulmonology, 5 YMCA Complex, Maharajbagh Road
Sitabuldi, Nagpur-440012
Nagpur MAHARASHTRA
0712-2523302 0712-2552067 ashoonikh@gmail.com
Dr Rajkumar Gautam Nikalje
Lifepoint Multispeciality Hospital
145/1 Mumbai Bangalore Highway Near Hotel Sayaji Wakad Pune-411057 Maharashtra India
Pune MAHARASHTRA
02066434366 0206-6434399 nikaljeraj80@gmail.com
Dr Micky Patel
Lotus Multispecialty Hospital
2nd floor, Block N, Krupa Residency, Motera Stadium Road, Motera-Sabarmati, Ahmedabad-380005, Gujarat, India Ahmadabad GUJARAT
NKP Salve Institute of Medical Sciences and Research Centre
NKP Salve Institute of Medical Sciences and Research Centre, Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur -440019, Maharashtra, India. Nagpur MAHARASHTRA
Patel Nagar, Dehradun- 248001, Uttarakhand, India Dehradun UTTARANCHAL
0135-6672400
dr.jagdishrawat@yahoo.com
Dr Gautam Moharil
Shrikrishna Hrudayalaya & Critical Care Centre
Shrikrishna Hrudayalaya & Critical Care Centre
Congress Nagar Square, Tikekar Road, Dhantoli
Nagpur-440012, Maharashtra, India.
Nagpur MAHARASHTRA
0712-2444434
gautam.moharil@gmail.com
Dr Arti Shah
Sumandeep Vidyapeeth and dhiraj general hospital,Medical College
Sumandeep Vidyapeeth an Institution deemed to be university and Dhiraj Hospital, At & Po Piparia, Taluka Waghodia, Vadodara 391760, Gujarat, India Vadodara GUJARAT
026-68245264 026-68245126 artidhawal76@gmail.com
Dr Sushama R Dugad
Supe Heart and Diabetes Hospital and Research Centre
Supe Heart and Diabetes Hospital and Research Centre, opp adhar asharam, Near Rungtha High School Gharpure Ghat Road Ashok stambh Panchavati Nasik 422002 Maharashtra India Nashik MAHARASHTRA
0253-2232487 0253-2232483 sushamadugad@gmail.com
Dr Jayeshkumar A Dobariya
Synergy Superspeciality Hospital
Synergy Superspeciality Hospital,
150 ft Ring Road, Ayodhya Chowk,
Opp - Gokul Mathura Apartment,
Rajkot, Gujarat, India, Pin-360005
Rajkot GUJARAT
2 inhalation twice daily Inhalation Aerosol 44 mcg
Intervention
Fluticasone propionate
2 Inhalation twice daily, Inhalation Aerosol USP, 44 mcg
Comparator Agent
Placebo inhaler
2 inhalation twice daily,HFA, pMDI
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Adult male or female subjects aged between 18 to 65 years of age (both ages inclusive)
2. Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program (NAEPP) at least 12 months prior to screening
3. Pre-bronchodilator FEV1 of more than or equal to 45% and less than or equal to 85% of the predicted normal value during the screening visit
4. Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to screening (Note:-Subject stabilized with dose of more than 250 mcg of Fluticasone should not be included in the study)
5. Currently non-smoking; has not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and has less than or equal to 10 pack years of historical use
6. More than or equal to 15% and 200 mL reversibility of FEV1 within 30 min following 360 mcg of Albuterol inhalation (pMDI) at screening (Note: Subjects not fulfilling reversibility of FEV1 at screening can be rescheduled for reversibility testing during the entire screening period and up to 1 day prior to randomization)
6 (a) More than or equal to 15% and 200 mL reversibility of FEV1 within 30 min following 360 mcg of Albuterol inhalation (pMDI) prior to randomization
7. Ability to discontinue their asthma medication (ICS and long-acting beta agonist) during the run-in period and for remainder of the study in the opinion of the investigator
8. Ability to replace short-acting beta agonists (SABAs) ongoing at screening with Salbutamol inhaler for use as needed for the duration of the study in the opinion of the Investigator; subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits
9. Women of childbearing potential must be willing to consistently use an appropriate method of contraception
10. Willingness to give their written informed consent to participate in the study
11. Is willing to comply with all aspects of the protocol
12. Ability to follow training given for study related procedures and assessments in the opinion of the Investigator
ExclusionCriteria
Details
1. Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year prior to the screening
2. Significant respiratory disease other than asthma 3. Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled diabetes mellitus (HbA1c more than 10%) uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, cardiovascular, endocrine, or other diseases that, in the opinion of the investigator, would put the subject at risk through study period, or would affect the study analyses if the disease exacerbates during the study 4.Known hypersensitivity to any sympathomimetic drug (e.g., Salbutamol/Albuterol) or to any inhaled, intranasal, or systemic corticosteroid therapy, or to propellant HFA-134a (1,1,1,2- tetrafluoroethane)
5. Subjects receiving B2-blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to the screening 6. Viral or bacterial, upper or lower respiratory tract infection, or sinus, or middle ear infection within 4 weeks prior to the screening visit 7. Subjects who required systemic or oral corticosteroids (for any reason) within the past 6 months prior to screening
8. Evidence or history of oral candidiasis, tuberculosis, hypercorticism, adrenal suppression, or eye problems 9. Subjects scheduled for pre-planned surgery during the treatment period or in the opinion of the Investigator is expected to undergo surgery based on their medical history details at the time of screening
10. Female subjects who are pregnant or breast-feeding or planning to be pregnant & Participation in another clinical trial within 3 months before screening, History or current drug substance abuse
11.Subjects with history or current significant alcohol consumption which as per investigators judgment, make the subject ineligible to participate in the study 12.Any other medical, surgical,psychiatric conditions or laboratory abnormalities that would patient at risk through study participation,which as per investigators judgment,make the subject ineligible to participate in the study or may increase potential risk for subject associated with study participation or that may affect study results interpretation
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period (test versus RLD)
Change from baseline in FEV1 measured in the morning prior to dosing of inhaled medications on the last day of 4-week treatment period (test versus placebo and RLD versus placebo).
last day of 4-week treatment period
Secondary Outcome
Outcome
TimePoints
Average use of rescue medications during the 4-week treatment period
4-week
Target Sample Size
Total Sample Size="1232" Sample Size from India="1232" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This
is a prospective, multi-center, randomized, assessor-blind, parallel-group,
comparative clinical endpoint BE study to compare the efficacy and safety of
Generic Fluticasone propionate inhalation aerosol (pMDI, HFA 134a) (test drug)
(of Macleods Pharmaceuticals Ltd.) versus the RLD FLOVENT HFA (pMDI) inhalation
aerosol and efficacy and safety of both test and RLD to a placebo-control in
treatment of patients with bronchial asthma. It is phase III/Clinical Endpoint Bioequivalence study. There are 6
scheduled study site visits during the entire study period; Visit 1 (Screening
period/Up to 7 days), Visit 2 (Start Day of run-in period/For 14 days [+3
days]), Visit 3 (Randomization/Start of 4-week treatment period/Day 1), Visit 4
(Interim study site visit during 4-week treatment period/Day 15 [±2 days]),
Visit 5 (End-of-treatment (EOT) study site visit/Day 28 [±1 day]) and Visit 6
(End-of-study [EOS] & Safety follow-up visit/Day 35 (±2 days) OR 7th
day (±2 days) after last dose day of IP. Telephonic contacts
will be established with subject during 4-week treatment with IP on Day 8
(±1 day) and Day 21 (±1 day) to remind about the study treatment compliance and
safety. Individual participation of the subject in the study will last for
approximately 62 days. The Investigator must voluntarily confirm subject’s willingness
to participate in the trial after having been informed of all aspects of the
trial that are relevant to the subject’s decision to participate in the trial.