| CTRI Number |
CTRI/2009/091/000547 [Registered on: 27/07/2009] |
| Last Modified On: |
27/02/2013 |
| 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 compare the efficacy and safety of a combination inhaler of Ciclesonide and Formoterol with Ciclesonide alone in patients with persistent asthma |
Scientific Title of Study
Modification(s)
|
A 6-weeks, double blind, active controlled, prospective, parallel, multicenter study to compare the efficacy and safety of a combination inhaler of Ciclesonide/Formoterol and Ciclesonide alone in subjects with persistent asthma |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CP/01/06 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sundeep Salvi |
| Designation |
|
| Affiliation |
|
| Address |
Chest Research Foundation,
Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune
Pune
MAHARASHTRA
411 014
India |
| Phone |
09921211000 |
| Fax |
|
| Email |
ssalvi@crfindia.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Jaideep A Gogtay |
| Designation |
Medical Director, Cipla Ltd. |
| Affiliation |
|
| Address |
Cipla Ltd.
Bellasis Road, Mumbai Central, Mumbai
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 |
|
| Affiliation |
|
| Address |
Chest Research Foundation
Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune 411 014
Pune
MAHARASHTRA
411 014
India |
| Phone |
09921211000 |
| Fax |
- |
| Email |
ssalvi@crfindia.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cipla Ltd., Bellasis Road, Mumbai Central, Mumbai, Phone : (022) 23082891 Fax : (022) 23070013 |
|
Primary Sponsor
Modification(s)
|
| Name |
Cipla Ltd |
| Address |
Bellasis Road, Mumbai Central, Mumbai, 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 = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Subhasish Ghosh |
Advanced Medicare & Research Institute (AMRI) |
Department of Pulmonology, Gariahat Road, Kolkata 700 029,NIL-700 029
Kolkata
WEST BENGAL |
(033) 24612626
NIL
subh_242202@bsnl.in |
| Dr. P. A. Mahesh |
Allergy, Asthma & Chest Centre |
1397, 4th Cross, Krishnamurthypuram, Mysore 570 004,NIL-570 004
Mysore
KARNATAKA |
(0821) 2332533/ 2432543
(0821) 2432543
mahesh1971in@yahoo.com |
| Dr. Pramod V. Niphadkar |
Asthma Allergy Centre |
Gurukripa, 1st Floor 66, Hindu Colony Lane- 1, Dadar (East), Mumbai 400 014,NIL-400 014
Mumbai
MAHARASHTRA |
(022) 24105656
(022) 24183232
dr_niphadkar@vsnl.net |
| Dr. K. S. Satish |
Chest and Maternity Centre |
No.878, 5th Block, Rajajinagar, Bangalore 560 010,NIL-560 010
Bangalore
KARNATAKA |
(080) 23408006
NIL
mamthasatish@gmail.com |
| Dr. Sundeep Salvi |
Chest Research Foundation |
Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune 411 014,NIL-411014
Pune
MAHARASHTRA |
(020) 27035361
(020) 27035371
ssalvi@crfindia.com |
| Dr. Jyotsna Joshi |
Dept of Respiratory Medicine |
T. N. Medical College & B.Y.L. Nair Charitable Hospital, Mumbai 400 008,NIL-400 008
Mumbai
MAHARASHTRA |
(022) 23081490
NIL
drjoshijm@gmail.com |
| Dr. Amita Athavale |
Dept. of Chest Medicine & EPRC |
K.E.M. Hospital & Seth G. S. Medical College, Parel, Mumbai 400 012.,NIL-400 012
Mumbai
MAHARASHTRA |
(022) 24132296
NIL
kempulmo@rediffmail.com |
| Dr. Virendra Singh |
Indian Asthma Care Society |
NIL,NIL-302016
Jaipur
RAJASTHAN |
(0141) 2281010
(0141) 2281010
drvirendrasingh@yahoo.com |
| Dr Nitin Abhyankar |
Poona Hospital & Research Centre |
NIL,NIL-411030
Pune
MAHARASHTRA |
-
020-24475609
nitimadh@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethical Committee Allergy Asthma and Chest Center for Dr P A Mahesh |
Approved |
| Ethics Committee Asthma & Allergy Centre for Dr. Pramod Niphadkar |
Approved |
| Ethics Committee for Research on Human Subjects for Dr. Athavale |
Approved |
| Independent Ethics Committee (IEC) for Dr. K.S.Satish-Chest and Maternity Centre |
Approved |
| Independent Ethics Committee for Dr. Sundeep Salvi |
Approved |
| Institutional Ethics Committee for T. N. Medical college & B.Y.L Nair Charitable Hospital for Dr. Jyostna Joshi |
Approved |
| RGCF Diagnostics Poona Hospital and Research Centre for Dr. Nitin Abhyankar |
Approved |
| Swasthya Kalyan Ethics Committee for Dr Virendra Singh |
Approved |
| The Institutional Ethics Committee of AMRI Hospitals for Dr. Subhashish Ghosh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Persistent asthma, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Ciclesonide |
80 mcg pMDI (1 puff twice daily) for 6 weeks. |
| Intervention |
Ciclesonide/Formoterol |
80/4.5 mcg combination pMDI (1 puff twice daily) for 6 weeks. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Written informed consent.
2.Male or female between 18 and 70 years of age inclusive of both.
3.Confirmed diagnosis of asthma according to GINA guidelines
4.Subjects with documented history of asthma who are either steroid naïve, on ICS+LABA combination or are on ICS (maximum daily dose up to 800 mcg budesonide, 1000 mcg Beclomethasone dipropionate (BDP) or 500 mcg Fluticasone) for at least 4 weeks prior to run-in.
5.FEV1 greater than or equal to 40 percent and Lesser than 80 prcent of the predicted normal value (as per the European Community for Coal and Steel formula and applying the correction factor of 0.9) when not taking short-acting bronchodilator medication for the previous 6 hours.
6.Able to demonstrate a 12 percent and 200 ml improvement in FEV1 within 30 minutes after inhalation of salbutamol 200 mcg / levosalbutamol 100 mcg unless reversibility is documented in the previous 6 months
7.Able to use the peak flow meter and perform the required pulmonary function tests before entering the run-in period
8.In the opinion of the investigator, able to comply with the requirements of the protocol.
9.The subject should demonstrate correct use of the pMDI.
|
|
| ExclusionCriteria |
| Details |
1.Known or suspected hypersensitivity to ciclesonide, formoterol or any other constituents of the Investigational Medicinal Product (IMP).
2.Clinical evidence or known history of any serious uncontrolled medical condition [e.g., cardiovascular (high pulse rate, irregular heart beat, high blood pressure), renal, neurological, hepatic, immunological, neoplastic, gastrointestinal, or endocrine disease] or any clinically significant abnormality (e.g., pneumonia, pulmonary fibrotic disease, active tuberculosis, chronic obstructive pulmonary disease (COPD) or pneumothorax), which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
3.Clinically relevant respiratory tract infection, as judged by investigator in the 4 weeks preceding the run-in period.
4.Females who are pregnant, lactating or planning to become pregnant
5.Women of child bearing age who are unwilling to take adequate contraceptive precautions unless abstinence is considered adequate in the investigators opinion
6.Clinically significant laboratory values, as judged by the investigator.
7.Subjects who have previously been enrolled into this study.
8.Receipt of an investigational drug within 30 days prior to study entry (screening visit)
9.Subjects who are scheduled to receive any other investigational drug during the course of the study.
10.Hospitalisation due to exacerbation of asthma within the previous 12 weeks preceding study entry (screening visit)
11.Use of oral, depot or parenteral steroids within 4 weeks of the run-in period
12.A smoking history of > or = 10 pack years
|
|
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, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean change in morning FEV1 |
At the end of 6 weeks of treatment period vs. baseline visit |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean morning pre-dose PEF values |
From baseline visit to 6 weeks of treatment period |
| Mean pre dose evening PEF values |
From baseline visit to 6 weeks of treatment period |
| Mean diurnal PEFR variation |
From baseline visit to 6 weeks of treatment period |
| Proportion of symptom-free days and the proportion of symptom free-nights |
From baseline visit to 6 weeks of treatment period |
| Use of rescue medication |
From baseline visit to 6 weeks of treatment period |
| Change in Mean Symptom score |
From baseline visit to 6 weeks of treatment period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
20/11/2006 |
| 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="4"
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)
|
The purpose of the study was to compare the efficacy and safety of a combination inhaler of Ciclesonide/ Formoterol and Ciclesonide alone in subjects with persistent asthma over 6 weeks of treatment period. In this study we have evaluated the effect of novel combination inhaler containing the inhaled corticosteroids Ciclesonide and the long acting beta agonist Formoterol in patients with persistent bronchial asthma. From this study we were able to demonstrate that the combination of Ciclesonide and Formoterol produced a greater improvement in lung function than ciclesonide alone. |