| CTRI Number |
CTRI/2010/091/000631 [Registered on: 14/07/2010] |
| Last Modified On: |
13/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects and safety of 2.5 microgram and 5 microgram Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 microgram delivered by the HandiHaler in patients with Chronic Obstructive Pulmonary Disease (COPD). |
Scientific Title of Study
Modification(s)
|
A randomized, active controlled, double blind, double dummy, parallel group, design, multi-centre, trial to compare, the efficacy and safety of 2.5 microgm and 5 microgm Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 microgm delivered by the HandiHaler® |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| BI 205.452 |
Protocol Number |
| NCT01126437 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| 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)
|
| Name |
Dr Shubhangi Desai |
| Designation |
|
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
SIRO Clinpharm Pvt. Ltd.
DIL Complex, Second Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400610
India |
| Phone |
02225848000 |
| Fax |
02225848275 |
| Email |
shubhangi.desai@siroclinpharm.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Shubhangi Desai |
| Designation |
Head Clinical Operations - Asia Pacific |
| Affiliation |
SIRO Clinpharm Pvt. Ltd. |
| Address |
SIRO Clinpharm Pvt. Ltd.
DIL Complex, Second Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road
Thane
MAHARASHTRA
400610
India |
| Phone |
02225848000 |
| Fax |
02225848275 |
| Email |
shubhangi.desai@siroclinpharm.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany |
|
Primary Sponsor
Modification(s)
|
| Name |
Boehringer Ingelheim Pharma GmbH Co KGBinger Strasse Ingelheim am RheinGermany |
| Address |
Boehringer Ingelheim Pharma GmbH Co KGBinger Strasse Ingelheim am RheinGermany |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
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Countries of Recruitment
Modification(s)
|
India
Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Colombia
Costa Rica
Croatia
Denmark
Ecuador
Finland
France
Georgia
Germany
Greece
Guatemala
Hungary
Ireland
Israel
Italy
Latvia
Lithuania
Malaysia
Mexico
Netherlands
Norway
Panama
Peru
Philippines
Poland
Portugal
Romania
Russian Federation
Serbia
Slovakia
South Africa
Spain
Sweden
Switzerland
Thailand
Tunisia
Turkey
Ukraine
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMahesh P A |
Allergy Asthma Associates |
No.1397, 4th Cross, Krishnamurthypuram, Mysore-570 004, Karnataka
Mysore
KARNATAKA |
918212331546
mahesh1971in@yahoo.com |
| Dr Pramod Niphadkar |
Asthma Allergy Centre |
Gurukripa Building, 1st Floor, 66, Hindu Colony, Lane No- 1, D V Pradhan Road, Dadar (East)- 400 014
Mumbai
MAHARASHTRA |
02224135178
dr_niphadkar@vsnl.net |
| DrAshish Malpani |
Asthma Bhawan |
R-3 Sector- 6, Opposite Cinestar Cinema Hall, Vidya Nagar, Jaipur- 302 023
Jaipur
RAJASTHAN |
01412235005
drashish19@gmail.com |
| DrAkash L Balki |
Cancer Care Clinic |
231,Everest Arcade,Sakkardara square,Umred Rd,Near Satkar travels, Nagpur-440009
Nagpur
MAHARASHTRA |
917122705904
akash_balki@yahoo.com |
| DrK Jagannath |
Chennai Thoracic Research Institute, |
47 (53), Sterling Road, Nungambakkam,
Chennai- 600034
Tamil Nadu
Chennai
TAMIL NADU |
914428250957
jagannath@sify.com |
| DrJagdeep Whig |
Dayanand Medical College & Hospital (D M C & Hospital) |
Tagore Nagar, Civil Lines, Ludhiana- 141 001
Ludhiana
PUNJAB |
01614687502
vice.principal@dmch.edu |
| DrNarendra Khippal |
Dr. Khippals Clinic |
Bunglow no.2,
In front of Krishnakripa 2,
Subhash Nagar Shopping centre,
Jaipur – 302016
Jaipur
RAJASTHAN |
01414007619
drnkhippal@rediffmail.com |
| DrRajesh Swaranakar |
Getwell Hospital |
20/1, Khare Marg, Dhantoli, Nagpur-440015
Nagpur
MAHARASHTRA |
917122440112
rajeshswarnakar@yahoo.co.in |
| DrE Ravindra Reddy |
Kamineni Hospital |
Lal Bahadur Nagar, Dilsukh Nagar, Cross Road, Hyderabad – 500 068
Hyderabad
ANDHRA PRADESH |
04039879700
rvndrreddy@yahoo.com |
| DrV Nanda Gopal |
Karthik Polyclinic - Asthma Allergy Respiratary Care |
101/67, Karunanidhi Nagar, Behind Sungam Chintamani, Trichy road, Ramanathapuram,
Coimbatore – 641045, Tamil Nadu, India
Coimbatore
TAMIL NADU |
914224223383
dr_nanda@yahoo.com |
| DrPradyut Waghray |
Kunal Institute of Medical Specialities Pvt. Ltd. |
5-9-41/1/A, New MLA quarter lane, Basher bagh, Hyderabad-500029
Hyderabad
ANDHRA PRADESH |
04023232946
pradyut_waghray@rediffmail.com |
| DrPuneet Rhijwani |
Mahatma Gandhi Medical College & Hospital |
R I C C O Institutional Area, Sitapura, Tonk Road, Jaipur- 302 022
Jaipur
RAJASTHAN |
01412771777
puneet284@rediffmail.com |
| DrK Srikanth |
P S G Institute of Medical Science & Research |
Avinash road,Peelamedu, Coimbatore-641 004,Tamil Nadu,India
Coimbatore
TAMIL NADU |
914222570170
drsrikanthcbe@yahoo.com |
| DrRaj Bhagat |
Pathik |
Behind Paldi Bus stand,
Dashaporwad Society Naka,
Paldi, Ahmedabad - 380007,
Gujarat
Ahmadabad
GUJARAT |
07926588062
rajpurvi@yahoo.com |
| DrManish Jain |
Shwaas Centre, Navkar Hospital |
11,Shubham Apartment, Central Spine, Vidhyadharnagar, Jaipur-302023,Rajasthan
Jaipur
RAJASTHAN |
01412338257
dtlung@hotmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Cerebral Independent Review Board,Hyderabad |
Approved |
| CLINICOM Committee for Evaluation of Protocols for Clinical Research |
Approved |
| CLINICOM Committee for Evaluation of Protocols for Clinical Research - Dr Bhagat |
Approved |
| CLINICOM Committee for Evaluation of Protocols for Clinical Research - Dr Nandagopal V |
Approved |
| Ethics Committee for Asthma, Allergy and COPD(ECAAC), Dadar |
Approved |
| Ethics Committee of Bansal Hospital and Research Centre, Jaipur |
Approved |
| Ethics Committee of Central Thorasic Research Institute |
Approved |
| Ethics Committee, Allergy Asthma Associates, Mysore |
Approved |
| Independent Ethics Committee, Get well Hospital and Research Institute, Nagpur |
Approved |
| Institutional Ethics Committee of Mahatma Gandhi Medical College and Hospital, Jaipur |
Approved |
| Institutional Ethics Committee, Kamineni Hospitals, Hyderabad |
Approved |
| Institutional Ethics Committee, Dayanand Medical College and Hospital, Ludhiana |
Approved |
| Institutional Human Ethics Committee, PSG IMS and R, Coimbatore |
Approved |
| Medcity Independent Ethics Committee of Chest Care Hospital, Nagpur |
Approved |
| S.R.Kalla Memorial Ethical Committee for Human Research, Jaipur |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
|
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Pulmonary Disease, Chronic Obstructive, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Tiotropium Inhalation Capsule 18 micro gram |
Substance (INN): Tiotropium
Pharmaceutical form: Inhalation capsule
Unit strength: 18 micro gram
Route of administration: Oral inhalation via HandiHaler® device
Dosage regimen: 1 inhalation once daily (a.m. dosing) |
| Intervention |
Tiotropium Inhalation solution 2.5 microgm |
Substance (INN): Tiotropium
Pharmaceutical form: Inhalation solution
Unit strength: 2.5 microgm (1.25 microgm per puff)
Route of administration:Oral inhalation via Respimat® inhaler
Dosage regimen: 2 inhalations once daily (a.m. dosing)
Substance |
| Intervention |
Tiotropium Inhalation solution 5 micro gram |
Substance (INN): Tiotropium
Pharmaceutical form: Inhalation solution
Unit strength: 5 microgram (2.25 micro gram per puff)
Route of administration: Oral inhalation via Respimat® inhaler
Dosage regimen: 2 inhalations once daily (a.m. dosing)
Substance |
| Comparator Agent |
Tiotropium placebo Inhalation capsule |
Substance (INN): Tiotropium placebo
Pharmaceutical form: Inhalation capsule
Unit strength: Placebo
Route of administration: Oral inhalation via HandiHaler® device
Dosage regimen: 1 inhalation once daily (a.m. dosing) |
| Comparator Agent |
Tiotropium placebo Inhalation solution |
Substance (INN): Tiotropium placebo
Pharmaceutical form: Inhalation solution
Unit strength: Placebo
Route of administration: Oral inhalation via Respimat® inhaler
Dosage regimen: 2 inhalations once daily (a.m. dosing) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
2. Male or female patients 40 years of age or older.
3. Patients must be current or ex-smokers with a smoking history of 10 pack-years. (Patients who have never smoked cigarettes must be excluded)
4. All patients must have a diagnosis of COPD (P06-12085), and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 less than 70% of predicted normal and post-bronchodilator FEV1 / FVC less than 70% |
|
| ExclusionCriteria |
| Details |
1.Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patients ability to participate in the study.
2.Patients with a recent history (i.e., six months or less) of myocardial infarction.
3.Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
4.Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
5.Known active tuberculosis.
6.Patients with a history of asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease. |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. Time to death (all-cause mortality) |
24 Months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| 1. Time to first major adverse cardiovascular event |
24 Months |
| 2. Number of COPD exacerbations |
24 Months |
| 3. Time to first hospitalization due to COPD exacerbation |
24 Months |
| 4. Number of hospitalizations due to COPD exacerbation |
24 Months |
|
Target Sample Size
Modification(s)
|
Total Sample Size="16800"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
24/06/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
14/05/2010 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A randomized, active controlled, double blind, double dummy, parallel group, design, multi-centre, trial to compare, the efficacy and safety of 2.5 microgm and 5 microgm Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 microgm delivered by the HandiHaler® in patients with Chronic Obstructive Pulmonary Disease (COPD). The primary outcome measures will be Time to death (all-cause mortality) and Time to first COPD exacerbation. The secondary outcomes will be Time to first major adverse cardiovascular event, Number of COPD exacerbations, Time to first hospitalisation due to COPD exacerbation and Number of hospitalisations due to COPD exacerbations. Target Sample size for India-500 subjects |