| CTRI Number |
CTRI/2009/091/000179 [Registered on: 14/05/2009] |
| Last Modified On: |
14/07/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Crossover Trial |
Public Title of Study
Modification(s)
|
A clinical study to evaluate efficacy and safety of arformoterol inhalation solution delivered by a nebulizer in subjects with chronic obstructive pulmonary disease (COPD). |
Scientific Title of Study
Modification(s)
|
A randomized, double blind, prospective, single dose, placebo-controlled, cross over study to evaluate efficacy and safety of arformoterol inhalation solution (R,R-Formoterol) delivered by a nebulizer in subjects with chronic obstructive pulmonary disease (COPD) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CP/02/07 Version 2 dated July 4, 2007 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sundeep Salvi |
| Designation |
Director |
| Affiliation |
Chest Research Foundation |
| Address |
Chest Research Foundation, Marigold Premises,
Survey No.15,
Vadgaon Sheri,
Kalyani Nagar
Pune
MAHARASHTRA
411 014
India |
| Phone |
09921211000 |
| Fax |
020-27035371 |
| Email |
ssalvi@crfindia.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Jaideep A Gogtay |
| Designation |
Medical Director |
| Affiliation |
Cipla Ltd. |
| Address |
Cipla Ltd.,
Bellasis Road,
Mumbai Central
Mumbai
MAHARASHTRA
400 008
India |
| Phone |
022-23025412 |
| Fax |
022-25787855 |
| Email |
jgogtay@cipla.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sundeep Salvi |
| Designation |
Director |
| Affiliation |
Chest Research Foundation |
| Address |
Chest Research Foundation, Marigold Premises,
Survey No.15,
Vadgaon Sheri,
Kalyani Nagar
Pune
MAHARASHTRA
411 014
India |
| Phone |
09921211000 |
| Fax |
020-27035371 |
| Email |
ssalvi@crfindia.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cipla Ltd., Bellasis Road, Mumbai Central, Mumbai 400 008. Phone:(022) 23082891 Fax:(022)25787855 |
|
Primary Sponsor
Modification(s)
|
| Name |
Cipla Ltd |
| Address |
Cipla Ltd., Bellasis Road, Mumbai Central, Mumbai 400 008. Phone:(022) 23082891 Fax:(022)25787855 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr P A Mahesh |
Allergy, Asthma & Chest Centre |
Consultant in Allergy Asthma, Tuberculosis and Chest Diseases, 1397, 4th Cross,,Krishmurthypuram,-570 004
Mysore
KARNATAKA |
0821-2331546
-
mahesh1971in@yahoo.com |
| Dr Manish Jain |
Asthma Bhawan |
R 3, Sector 6,,Near Cine Star, Vidhydhar Nagar-302023
Jaipur
RAJASTHAN |
0141-2338257
0141-2235005
doctor_manish2003@yahoo.co.in |
| Dr S Balamurugan |
Chest Research Centre |
Chest Research Centre, No. 2, 1st Cross Street, Janaki Nagar Extn.,Valasaravakkam-600 087
Chennai
TAMIL NADU |
9841090860
-
dr.s.bala@gmail.com |
| Dr Sundeep Salvi |
Chest Research Foundation |
Chest Research Foundation, Marigold Premises, Kalyani Nagar,Vadgaon Sheri,-411 014
Pune
MAHARASHTRA |
020-27035361
020-27035371
ssalvi@crfindia.com |
| Dr Narender Khippal |
Dr. Narender Khippal Clinic |
Dept. of Chest & Respiratory Medicine, B5 Durga Vihar, Seeta bari,,Tonk Road,-302018
Jaipur
RAJASTHAN |
9829017619
-
drnkhippal@rediffmail.com |
| Dr B S Jayaraj |
JSS Medical College Hospital |
Department of Pulmonology, Professor & Head, JSS Medical College Hospital, Ramanuja Road,Mysore -570 004
Mysore
KARNATAKA |
0821-2517203
-
drjayarajbs@yahoo.com |
| Dr V Nandagopal |
Karthik Polyclinic |
101- Karunanidhi Nagar,Behind Sungam Chinthamani,Trichy Road, Ramanathapuram,- 641045
Coimbatore
TAMIL NADU |
04222211000
-
dr_nanda@yahoo.com |
| Dr K Gowrinath |
Kasturba Medical College & Hospital |
Department of Tuberculosis & Respiratory Diseases, Professor & HOD, Kasturba Medical College & Hospital, Madhav Nagar,Manipal-576104
|
0820-2571202
-
drkgowrinath@yahoo.com |
| Dr S Mahadevan |
Kovai Medical Centre and Hospital |
Department of Pulmonary Medicine,Coimbatore-641 014
Coimbatore
TAMIL NADU |
04222598247
-
drmahadevan2002@yahoo.com |
| Dr Srikanth K |
PSG Institute of Medical Science & Research |
Department of Respiratory Medicine, Associate Professor & Head of Department,PSG Institute of Medical Science & Research, Coimbatore-641004
Coimbatore
TAMIL NADU |
9894257706
-
drsrikanthcbe@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| CLINICOM, Independent Ethics Committee for Dr. Narender Khippal Clinic |
Approved |
| CLINICOM, Independent Ethics Committee for Dr. S. Balamurugan |
Approved |
| CLINICOM, Independent Ethics Committee for Karthik Polyclinic-DrVNandagopal |
Approved |
| Ethics Committee for Allergy Asthma And Chest Center |
Approved |
| Independent Ethics Committee for Chest Research Foundation-Dr. Sandeep Salvi |
Approved |
| Institutional Ethics Committee of JSS Medical College for JSS Medical College Hospital-Dr. Jayaraj B.S. |
Approved |
| Institutional Human Ethics Committee for PSG Institute of Medical Science & Research-Dr. K. Srikanth |
Approved |
| KMCH Ethics Committee for Kovai Medical Centre and Hospital |
Approved |
| Manipal University Ethics Committee for Kasturba Medical College & Hospital Manipal- Dr.Gowrinath K |
Approved |
| Swasthya Kalyan Ethics Committee for Asthma Bhawan-Dr. Manish Jain |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Chronic Obstructive Pulmonary Disease (COPD), |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Arformoterol Nebulized solution |
15 mcg/2ml Administered through a nebulizer, single dose over 6 minutes |
| Comparator Agent |
Placebo Nebulized solution |
2ml Administered through a nebulizer, single dose over 6 minutes |
|
Inclusion Criteria
Modification(s)
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Day(s) |
| Gender |
Both |
| Details |
1. Subjects willing to give a written informed consent.
2. Subjects aged 35 years and above.
3. Subjects diagnosed with COPD as per GOLD guidelines (FEV1/FVC < 70% and FEV1 < 80% predicted) with FEV1 <65% of predicted normal value and >0.70 L at screening visit.
4. Smoking history of at least 10 pack-years.
|
|
| ExclusionCriteria |
| Details |
1. Subjects requiring continuous supplemental oxygen therapy. The use of supplemental oxygen, not exceeding 2 L/minute, at night time only and/or only during exercise is allowed.
2. Change in dose or type of any medications for COPD within 14 days prior to the screening visit.
3. History of asthma or any chronic respiratory disease other than COPD.
4. Hospitalization for pulmonary exacerbation within the past 2 months.
5. Life-threatening/unstable respiratory status, including upper or lower respiratory tract infection, within the previous 30 days.
6. History of lung resection of more than one full lobe.
7. Using any prescription drug for which concomitant beta-agonist administration is contraindicated (e.g., beta-blockers).
8. Absolute Blood eosinophil count >600 cells/c mm of blood.
9. Have a known sensitivity to formoterol, ipratropium, salbutamol, levosalbutamol or any of the excipients contained in any of these formulations.
10. Treatment with any other investigational drug in last 30 days prior to screening
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Pre-numbered or coded identical Containers |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean difference in AUC FEV1 |
From baseline to 12 hrs |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean difference in AUC FVC |
from baseline to 12 hours |
| No. of subjects with > 10 % increase in FEV1 |
- |
| FEV1 and FVC mean maximum response |
From baseline to 12 hours |
| Time to maximum response |
From baseline to 12 hours |
| Time to onset of response (defined as increase in FEV1 by 10%) |
From baseline to 12 hours |
|
Target Sample Size
Modification(s)
|
Total Sample Size="211"
Sample Size from India="211"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
25/03/2008 |
| 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
Modification(s)
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a multi-centre randomized, double blind, single dose, placebo-controlled, cross over study to evaluate efficacy and safety of arformoterol inhalation solution delivered by a nebulizer in subjects with chronic obstructive pulmonary disease (COPD). The study was carried out in ten centers in India. Two hundred and twelve patients were enrolled into the study. The primary endpoint is a mean difference in AUC FEV1 from baseline to 12 hrs, and the secondary endpoints would be mean difference in AUC FVC from baseline to 12 hours,.FEV1 and FVC mean maximum response. Time to onset of response (defined as increase in FEV1 by 10%), No. of subjects with > 10 % increase in FEV1, time to maximum response. |