| CTRI Number |
CTRI/2009/091/001015 [Registered on: 31/05/2010] |
| Last Modified On: |
07/01/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
FLT3507: A study to assess the efficacy and safety of FLUTIFORM® pMDI 125/5 μg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 μg (2 puffs bid) in adolescent and adult subjects with moderate to severe persistent, reversible asthma. |
|
Scientific Title of Study
|
FLT3507: A double blind, double dummy, randomised, multicentre, two arm parallel group study to assess the efficacy and safety of FLUTIFORM® pMDI 125/5 μg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 μg (2 puffs bid) in adolescent and adult subjects with moderate to severe persistent, reversible asthma. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
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| Secondary ID |
Identifier |
| 2009-017223-25 |
EudraCT |
| FLT3507 Version 1.0 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Ataali shaikh |
| Designation |
Senior Director |
| Affiliation |
Kendle India Pvt Ltd |
| Address |
Kendle India Pvt Ltd. Unit 002, Ground Floor, Tower C, Cyber Park, Sector 39,
Gurgaon
HARYANA
122001
India |
| Phone |
912241922000 |
| Fax |
|
| Email |
shaikh.ataali@kendle.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
DrMamta Singh |
| Designation |
|
| Affiliation |
Kendle India Pvt Ltd |
| Address |
Kendle India Pvt Ltd. Unit 002, Ground Floor, Tower C, Cyber Park, Sector 39,
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
masingh@incresearch.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
DrMamta Singh |
| Designation |
|
| Affiliation |
Kendle India Pvt Ltd |
| Address |
Kendle India Pvt Ltd. Unit 002, Ground Floor, Tower C, Cyber Park, Sector 39,
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
masingh@incresearch.com |
|
Source of Monetary or Material Support
Modification(s)
|
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Primary Sponsor
Modification(s)
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| Name |
Mundipharma Research Limited UK |
| Address |
Cambridge Science Park, Milton road, Cambridge CB40AB,UK |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Kendle India Pvt Ltd |
Ground floor, Tower C, Cyber park, Sector 39, Gurgaon, Haryana 122001, India |
| NIL |
|
|
Countries of Recruitment
Modification(s)
|
India
Bulgaria
Hungary
Poland
Romania |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tushar Patel |
"Consultant Pulmonologist and Critical Care Specialist, G-9436, Sterling Hospital, Sterling Hospital Road, Memnagar" |
,-380052
Ahmadabad
GUJARAT |
91 79 4001 111
drtusharpatel@yahoo.com |
| Dr George D'souza |
"Department of Medicine, Division of Chest Medicine St. Johns Medical College, Sarjahpur Road. " |
,-560034
Bangalore
KARNATAKA |
918022065508
dsouza.ga@gmail.com |
| Dr Ajay Shah |
"Shrey Hospital Pvt Ltd. 270/B/5, Near AMCO Bank, Behind Navrangpura Bus Stop" |
,-380009
Ahmadabad
GUJARAT |
91 79 27502590
doctoranshah@yahoo.com |
| Dr Amrutha D Holla |
Allergy Asthma Associates, Mysore |
"Allergy Asthma Associates 1#397, 4th Cross, Krishnamurthypuram, MYSORE - 570 004," ,-570 004
|
08212432543
amruthadh@yahoo.com |
| Dr. Salil Bhargava |
Gyanpushp Research Centre for Allergy & Chest Diseases, Indore |
Gyanpushp Research Centre for Allergy and Chest Diseases,SURABHI" 76, Dhar kothi,Residency Area,-452001
Indore
MADHYA PRADESH |
07312711611
bhargavasalil@hotmail.com |
| Dr Mathew Thomas |
Health and Research Centre |
T.C. 1/907, 1st Floor, Devi Scans Building Kumarapuram Medical College P.O."
Thiruvananthapuram
KERALA |
914712554911
healthtrials@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics committee of Diabetes thyroid hormone research institute for Dr Salil Bhargava site |
Approved |
| Ethics committee of the health care clinic for Dr Ajay Shah Site |
Approved |
| Ethics committee, Allergy asthma associates for Dr Amrutha Hulla site |
Approved |
| Health And Research Centre for Doctor Thomas site |
Approved |
| St Johns medical college and hospital institutional ethics review board for Dr George D souza site |
Approved |
| sterling hospital ethics committee for Dr Tushar Patel site |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Asthma Bronchiale, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
FLUTIFORM TM Inhaler |
Dosage:2 puffs unit strength-125/5 microgram, dosing frequency:q12h
Mode of administration:Inhaled
Duration:12 weeks |
| Comparator Agent |
Symbicort® Turbohaler |
Dosage form: 2 puffs unit strength-200/6 microgram Dosing frequency:q12h
Mode of administration:Inhaled
duration of treatment-12 weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects at least 12 years old.
2. Female subjects less than one year post-menopausal must have a negative urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.
3. Known history of moderate to severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterised by: Treatment with an inhaled corticosteroid (ICS) at a dose of 250 , 1000 μg fluticasone or equivalent OR Treatment wth ICS at a dose of 200-500 μg fluticasone or equivalent in combination with a Long Acting β2-Agonist (LABA).
4. Demonstrated a FEV1 of ≥ 50% to ≤ 80% for predicted normal values (Quanjer et al., 1993 (adults), and 1995 (adolescents)) during the Screening Period (Visit 1 or Visit 2) following appropriate withholding of asthma medications (if applicable). - No β2-agonist use on day of testing - No use of inhaled combination asthma therapy on day of testing. - Inhaled corticosteroids are allowed on day of testing.
5. Documented reversibility of ≥ 15% in FEV1 at visit 1 or visit 2.
6. Demonstrated satisfactory technique in the use of the study medications i.e. pMDI and Dry Powder Inhaler (DPI) devices.
7. Willing and able to enter information in the electronic diary and attend all study visits.
8. Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
9. Written informed consent obtained.
10. Subject has used rescue medication for at least 3 days and had at least one night with sleep disturbance (i.e., sleep disturbance score of ≥ 1) during the last 7 days of the run in period, OR subject has used rescue medication for at least 3 days and had at least 3 days with asthma symptoms (i.e., a symptom score of ≥ 1) during the last 7 days of the run-in period. |
|
| ExclusionCriteria |
| Details |
1. Near fatal or life-threatening (including intubation) asthma within the past year.
2. Hospitalisation or an emergency visit for asthma within the 4 weeks before the Screening Visit.
3. Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the Screening Visit.
4. Known history of omalizumab use within the past 6 months.
5. Current evidence or known history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. Clinically significant‟ is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
6. In the investigator‟s opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
7. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
8. Known Human Immunodeficiency Virus (HIV)-positive status.
9. Subject has a smoking history equivalent to 10 pack years (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc.).
10. Current smoking history within 12 months prior to the Screening Visit.
11. Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
12. Subject has taken -blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
13. Current use of medications other than those allowed in the protocol that will have an effect on bronchospasm and/or pulmonary function.
14. Current evidence or known history of hypersensitivity or idiosyncratic reaction to test medications or components.
15. Subject has received an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
16. Subject is currently participating in a clinical study. |
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| The primary endpoint is the change in pre-morning dose FEV1 values from baseline to the end of the 12 week treatment period. |
at week 12 from baseline to end otf treatment |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. asthma quality of life questionnaire (AQLQ(S) ≥12 years)
2. subject‟s assessment of study medication
3. amount of rescue medication use
4. asthma symptom scores
5. sleep disturbance due to asthma
6. discontinuations due to lack of efficacy
7. asthma excacerbations requiring oral/parenteral steroid use or medical intervention
8. compliance with study medication use
9. Post Dose FEV1
10.PEFR, and other lung function parameters. |
at 12 week and from baseline to end end of the treatment |
|
Target Sample Size
Modification(s)
|
Total Sample Size="260"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
15/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
14/04/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none |
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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)
|
Expected date of first enrollment in India is 3 June 2010.
72 Subject will be recruited from India.
35 Subject will be recruited from Bulgaria.
32 Subject will be recruited from Hungry.
102 Subject will be recruited from Poland.
19 Subject will be recruited from Romania.
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