| CTRI Number |
CTRI/2014/07/004752 [Registered on: 22/07/2014] Terminated Trial Registered |
| Last Modified On: |
08/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Pharmacology study of SUN Pharmas Dry powder inhaler in patients with moderate to severe asthma |
|
Scientific Title of Study
|
A RANDOMIZED, OPEN LABEL, TWO TREATMENT, TWO PERIOD, TWO SEQUENCE,
SINGLE DOSE, CROSSOVER, COMPARATIVE PHARMACOKINETIC &
PHARMACODYNAMIC STUDY OF SALMETEROL 25mg and FLUTICASONE PROPIONATE 250mg
DRY POWDER INHALER (SUN DPI) OF SUN PHARMA ADVANCED RESEARCH COMPANY
LIMITED, INDIA AND SERETIDETM ACCUHALERTM 50/500 (SALMETEROL 50mg and
FLUTICASONE PROPIONATE 500mg) DRY POWDER INHALER OF GLAXOSMITHKLINE IN
MODERATE TO SEVERE ASTHMATIC PATIENTS. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FLCSM _250-25DPI_3310_11 Version 01 amendment 01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Ltd. |
| Address |
Sun Pharma Advanced Research Company Ltd.
17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
02266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Ltd. |
| Address |
Sun Pharma Advanced Research Company Ltd.
17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
02266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Mudgal Kothekar MD |
| Designation |
Associate Vice President - Clinical Development |
| Affiliation |
Sun Pharma Advanced Research Company Ltd. |
| Address |
Sun Pharma Advanced Research Company Ltd., 17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
17-B, Mahal Industrial Estate, Off Mahakali Caves Road, Andheri (East), Mumbai 400093, India
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
02266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Advanced Research Company Limited
|
|
|
Primary Sponsor
|
| Name |
Sun Pharma Advanced Research Company Limited |
| Address |
Tandalja, Vadodara – 390 020. (INDIA) |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramraje Nagsen Nirgun |
Grant Medical College and Sir J.J. Group of Hospital |
Byculla, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA |
91-9825985265
akash.khobragade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Asthma patients, (1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Salmeterol 25 mcg and Fluticasone Propionate 250 mcg Dry Powder Inhaler |
Single dose oral inhalation; Cross over study with at least 5 days washout period between two doses. |
| Comparator Agent |
Seretide Accuhaler 50/500 |
Single dose oral inhalation; Cross over study with at least 5 days washout period between two doses. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
0.00 Year(s) |
| Gender |
Both |
| Details |
-Asthmatic subjects, 18 years of age or older
-Having no evidence of underlying disease (except asthma)
-Willing to sign the informed consent form
-Ability to use the dry powder inhaler correctly. |
|
| ExclusionCriteria |
| Details |
-Having history of clinically significant gastrointestinal, dermatological, cardiovascular,
renal, hematological, psychiatric, cerebrovascular, neurological, hepatic, pulmonary
-Having hypersensitivity or allergy to ingredients of the IP
-Subjects determined by the study physician to have any medical condition that could jeopardize
their health or prejudice the results
-Females who are pregnant, breastfeeding, or are likely to become pregnant. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| AUC 0-t , Cmax |
24-hours post dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AUC0-inf, tmax, t1/2, Kel |
24 hours pre-dose and up to 24 hours post-dose |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/11/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of the study is to monitor the safety of the subjects participating in the study and to assess the comparative pharmacokinetics & pharmacodynamics of Salmeterol 25mg and Fluticasone Propionate 250mg Dry Powder Inhaler (SUN DPI) of Sun Pharma Advanced Research Company Limited, India and SeretideTM AccuhalerTM 50/500 (Salmeterol 50mg and Fluticasone Propionate 500mg) Dry Powder Inhaler.
However, due to slow rate of recruitment, the study is withdrawn. No patient is enrolled in the study
|