| CTRI Number |
CTRI/2013/08/003878 [Registered on: 05/08/2013] Trial Registered Retrospectively |
| Last Modified On: |
05/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
Type of Study
Modification(s)
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to study and compare the pharmacokinetic and pharmacodynamic effects of two dry powder inhaler devices, test and reference containing Salmeterol 25mcg and fluticasone propionate 250mcg with salmeterol 50mcg and fluticasone propionate 500mcg in patients with 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 25 mcg and fluticasone propionate 250 mcg inhalation powder (SUN DPI) of Sun Pharma Advanced Research Company Limited, India and seretidetm diskus 50/500 (salmeterol 50mcg and fluticasone propionate 500mcg) inhalation powder of Glaxosmithkline in moderate to severe asthmatic patients. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FLCSM 250 25DPI 3310 11 a, V00, Amendment 03, 06/Nov/2012 |
Protocol Number |
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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
022 66455645
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
022 66455645
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
022 66455645
Mumbai
MAHARASHTRA
400 093
India |
| Phone |
02266455645 |
| Fax |
|
| Email |
clinical.trials@sparcmail.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Advanced Research Company |
|
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Primary Sponsor
|
| Name |
Sun Pharma Advanced Research Company Ltd |
| Address |
Tandaljia, VAdodara-390020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mallika Khanna |
Meridian Hospital |
Cardiology Department,
Diwalipura, Off Old Padra Road
Vadodara
GUJARAT |
0625-3087108
mallikakhanna06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vadodara Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
moderate to severe asthmatic patients, (1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Seretide Diskus (GSK) |
Salmeterol 50 mcg + fluticasone propionate 500 mcg
duration of therapy:One day |
| Intervention |
SUN DPI |
Salmeterol 25 mcg + fluticasone propionate 250 mcg
Duration of therapy: one day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Eighteen years or older moderate to severe asthmatic subjects with weight at least 50 kg and BMI between 18.5-3.0 kg/m2
subjects who are willing to sign written consent form prior to study entry
subjects with clinically acceptable results from the screening procedure including blood pressure, pulse rate, 12-lead ECG, x-ray, physical examination, medical history, hematology, biochemistry, urinalysis and infection screen (Hepatitis C Antibody, HIV)
Diagnosis of asthma. |
|
| ExclusionCriteria |
| Details |
Subjects with a history of clinically significant gastrointestinal, dermatological, cardiovascular, renal, hematological, psychiatric, cerebrovascular, neurological, hepatic, pulmonary (significant respiratory disease other than asthma), or endocrine disease in the last 12 months;
Allergy or Significant history of hypersensitivity or idiosyncratic reactions to fluticasone and/ or salmeterol, milk proteins and /or any related compounds etc;
Subjects determined by the study physician to have any medical condition that could jeopardize their health or prejudice the results. (E.g. history of surgery of the gastro-intestinal tract, which may interfere with absorption, except for appendectomy);
Females who are pregnant, breastfeeding, or are likely to become pregnant;
Subjects with any clinically significant illness (including respiratory illness) within 4 weeks prior to Period 1 dosing, and Diagnosis of COPD
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Cmax,AUC, Tmax, t½
|
1h predose, 1min, 3min, 5min, 10min, 30min, 60min, 90min, 2h, 3h, 4h, 8h, 12h and 36h postdose
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Safety parameters |
at pre-dose and1, 2, 4 and 12 hours post-dose |
|
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Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/11/2012 |
| 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="0"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
The study was conducted to to monitor the safety of the subjects participating in the study and to assess the comparative pharmacokinetic & pharmacodynamic of Salmeterol 25mg + Fluticasone Propionate 250mg Inhalation Powder (SUN DPI) of Sun Pharma Advanced Research Company Limited, India and SeretideTM Diskus 50/500 (Salmeterol 50mg + Fluticasone Propionate 500mg) Inhalation Powder of GlaxoSmithKline in moderate to severe asthmatic patients. |