| CTRI Number |
CTRI/2011/12/002226 [Registered on: 14/12/2011] Trial Registered Prospectively |
| Last Modified On: |
29/01/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination |
|
Scientific Title of Study
|
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Salmeterol Xinafoate/ Fluticasone Propionate Combination |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| A6631029 |
Protocol Number |
| CT/110/11-DCG(I) dated 7 Dec 11, Protocol version 5 Jan 11 |
DCGI |
| NCT01321463 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India |
|
|
Primary Sponsor
|
| Name |
Pfizer Limited |
| Address |
Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
Argentina
Australia
Canada
Chile
Czech Republic
Hungary
India
New Zealand
Poland
Slovakia
South Africa
Sweden
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravindra Sarnaik |
Leela Mores Chest Clinic |
57, North Avenue, Dhantoli, Nagpur 440012, Maharashtra, India.
Nagpur
MAHARASHTRA |
91-712-2436384
91-712-2420373
lmccnagpur@yahoo.com |
| Dr Srikanth Krishnamurthy |
PSG Hospitals |
Department of TB & respiratory disease, Avinashi Road, Peelamedu
Coimbatore - 641004,
Tamil Nadu, India
Coimbatore
TAMIL NADU |
91-9894257706
91-422-2573556
drsrikanthcbe@yahoo.com |
| Dr Tushar Patel |
Sterling Hospitals |
Clinical Research Department
, Sterling Hospital Road
Memnagar, Ahmedabad - 380052, Gujarat, India
Ahmadabad
GUJARAT |
91-9825082672
91-79-40011622
drtusharpatel@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Breathe trust, Leela Mores’ Chest Clinic, Nagpur for Dr Ravindra Sarnaik |
Approved |
| Institutional Human Ethics Committee, PSGIMS & R, PSG hospitals, Coimbatore for Dr Dr. Srikanth Krishnamurthy |
Approved |
| Sterling Hospital Ethics committee, Sterling Hospitals , Ahmedabad for Dr Tushar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pulmonary Disease, Chronic Obstructive, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Experimental
Intervention: Drug: PH-797804
|
Drug: PH-797804
6 mg oral tablet once daily for 12 weeks
|
| Comparator Agent |
Placebo |
Drug: Placebo
Placebo oral tablet once daily for 12 weeks
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subjects between, and including, the ages of 40 and 80 years.
2. Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease.
3. Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up greater than 6 months ago.
4. Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening.
|
|
| ExclusionCriteria |
| Details |
1. A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
2. History or presence of significant cardiovascular disease.
3. ECG abnormalities.
4. Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
5. Evidence of organ or blood disorders. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment. |
12 weeks |
| 2. Dyspnea index scores |
12 weeks |
| 3. Rescue bronchodilator usage |
12 Weeks |
| 4. Symptom scores. |
12 weeks |
| 5. Global impression of change (patient and clinician). |
12 weeks |
| 6. Blood sample for pharmacokinetics. |
12 weeks |
| 7. Blood and urine sample for biomarkers and molecular profiling. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="328"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/06/2011 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a 12 week, randomized, double blind, placebo-controlled, parallel group multi center study to evaluate the efficacy and safety of oral PH-797804 (6 mg) in adult patients with moderate-to-severe COPD as defined by GOLD (Global strategy for the diagnosis, management, and prevention of COPD, Update 2009, [stages II-III already treated with a background of LABA/ICS combination in 328 patients that will be conducted in 16 countries including India.
Study design: The study comprises 8 clinic visits: a Screening visit, 1 visit during the run-in phase (Week -1), a baseline/randomization visit (Week 0) at the start of the double-blind treatment phase, 4 visits during the double-blind treatment phase (Weeks 2, 6, 10 and 12) and a Follow-up visit (Week 14). At the beginning of the double-blind treatment phase (Week 0), subjects will be randomized to receive either PH-797804 (6 mg) once daily (QD) + salmeterol xinafoate/fluticasone propionate combination twice daily (BID) or matching placebo + salmeterol xinafoate/fluticasone propionate combination twice daily (BID).
Trial has been completed.
|