| CTRI Number |
CTRI/2009/091/000118 [Registered on: 04/08/2009] |
| Last Modified On: |
15/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Montelukast Asthmatic Smoker Study |
Scientific Title of Study
Modification(s)
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A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients with Chronic Asthma Who Smoke Cigarettes. |
| Trial Acronym |
MK-476-332 |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MK-0476-332 |
Protocol Number |
| NCT00284856 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
DrMonisha Sharma |
| Designation |
Director Clinical Research India |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd |
| Address |
MSD Pharmaceuticals Pvt Ltd
6th Floor, Vatika Towers - B, Golf Course Road Sector 54, Gurgaon HARYANA 122002 India
Gurgaon
HARYANA
122002
India
Gurgaon
HARYANA
122002
India |
| Phone |
0124-4647300 |
| Fax |
0124-4375561 |
| Email |
monisha_sharma@merck.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Monisha Sharma |
| Designation |
Director Clinical Research India |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd |
| Address |
MSD Pharmaceuticals Pvt Ltd
6th Floor, Vatika Towers - B, Golf Course Road Sector 54, Gurgaon HARYANA 122002 India
Gurgaon
HARYANA
122002
India
Gurgaon
HARYANA
122002
India |
| Phone |
0124-4647300 |
| Fax |
0124-4375561 |
| Email |
monisha_sharma@merck.com |
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Source of Monetary or Material Support
Modification(s)
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| Merck and Co is the sponsor of the study |
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Primary Sponsor
Modification(s)
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| Name |
Merck Co Inc |
| Address |
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889-0100, U.S.A. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
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Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
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| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pramod Niphadkar |
Asthma Allergy center |
Gurukripa Building, ,1st Floor, 66 Hindu Colony, Lane No. 1, D. V. Pradhan Road, Dadar (E)-400014
Mumbai
MAHARASHTRA |
912224105656
912224123838
dr_niphadkar@vsnl.net |
| Srikanth Krishnamurthy |
PSG Hospital, |
PSG Hospital, ,Peelamedu,-641004
Coimbatore
TAMIL NADU |
+91-9894257706
+91-422-2573556
drsrikanthcbe@yahoo.com |
|
Details of Ethics Committee
Modification(s)
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| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Asthma Allergy Centre Ethics Committee |
Approved |
| Institutional Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Chronic Asthma Who Smoke Cigarettes., (1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Comparator Agent |
fluticasone |
fluticasone propionate 250 mcg twice daily, 6 month treatment period. |
| Intervention |
montelukast sodium |
montelukast 10 mg tablet once daily. 6 month treatment period |
| Comparator Agent |
Placebo |
Drug: Comparator: Placebo
fluticasone propionate 250 mcg Pbo twice daily, 6 month treatment period.
Drug: Comparator: Placebo.
montelukast 10 mg Pbo tablet once daily, 6 month treatment period. |
|
Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day |
|
| ExclusionCriteria |
| Details |
Patient can not have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema |
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Method of Generating Random Sequence
Modification(s)
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Stratified block randomization |
Method of Concealment
Modification(s)
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Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
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| Outcome |
TimePoints |
| Percentage of asthma-control days over the 6-month treatment period |
Time Frame: 6 months [ Designated as safety issue: No ]
|
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Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
| AM Peak Expiratory Flow Rate (PEFR) and daytime symptom score over the 6-month treatment period |
Time Frame: 6 months [ Designated as safety issue: No ] |
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Target Sample Size
Modification(s)
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Total Sample Size="1000"
Sample Size from India="11"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
29/06/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
05/05/2006 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="11"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NAP |
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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)
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Number of Indian subjects proposed for enrollment in this global study is 30 Date of first enrollment (India)- 29 Jun 2009 |