CTRI

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CTRI Number

CTRI/2009/091/000111 [Registered on: 13/05/2009]

Last Modified On:

13/11/2018

Post Graduate Thesis

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 fixed dose combination of Formoterol fumarate & Mometasone furoate dry powder inhaler and fixed dose combination of Formoterol fumarate & Budesonide dry powder inhaler in patients with bronchial asthma and/or chronic obstructive pulmonary disease (COPD).

Scientific Title of Study
Modification(s)

An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination of Formoterol fumarate & Mometasone furoate Dry Powder Inhaler DPI and fixed-dose combination of Formoterol fumarate & Budesonide Dry Powder Inhaler (DPI) for the treatment of bronchial asthma and or COPD.

Trial Acronym

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
08-21	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)

Name	Dr Ravindra Mittal
Designation
Affiliation
Address	Cadila Healthcare Ltd. Zydus Tower, Satellite Cross Roads, Ahmedabad Ahmadabad GUJARAT 380015 India
Phone	07926868211
Fax	07926862362
Email	r.mittal@zyduscadila.com

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Ravindra Mittal
Designation
Affiliation	Cadila Healthcare Ltd.
Address	Cadila Healthcare Ltd. Zydus Tower, Satellite Cross Roads, Ahmedabad Ahmadabad GUJARAT 380015 India
Phone	07926868211
Fax	07926862362
Email	r.mittal@zyduscadila.com

Details of Contact Person
Public Query
Modification(s)

Name	Dr Ravindra Mittal
Designation
Affiliation
Address	Cadila Healthcare Ltd. Zydus Tower, Satellite Cross Roads, Ahmedabad Ahmadabad GUJARAT 380015 India
Phone	07926868211
Fax	07926862362
Email	r.mittal@zyduscadila.com

Source of Monetary or Material Support
Modification(s)

Cadila Healthcare Ltd.

Primary Sponsor
Modification(s)

Name	Cadila Healthcare Ltd
Address	Cadila Healthcare Ltd Zydus Tower Satellite Cross Road Ahmedabad 380 015 Gujarat
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor
Modification(s)

Name	Address
NIL

Countries of Recruitment
Modification(s)

India

Sites of Study
Modification(s)

No of Sites = 5
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr. Tushar B. Patel	ASHRAI ASSOCIATES, Ahmedabad	ASHRAI ASSOCIATES,110, 111,112 Ellisbridge centre, Ellisbridge- Ahmadabad GUJARAT	079-26579550 drtusharpatel@yahoo.com
Dr Narendra Khippal	Chest & TB Hospital	Banglow No. 2, Subhash Nagar Shopping Centre,Opposite Krishna Kripa- 2- Jaipur RAJASTHAN	09829017619 drnkhippal@rediffmail.com
Dr. S. Z. Jafrey	Indore Chest Centre, Indore	Indore Chest Centre,Indore- Indore MADHYA PRADESH	0731-4064786 indorechestcentre@yahoo.com
Dr. N. T. Awad	L.T.M. Medical College & L.T.M.G.H.	Dept. Of Respiratory Disease,L.T.M. Medical College, Sion,- Mumbai MAHARASHTRA	022-24076381 Ext# 247/531
Dr. Puneet Rijhwani	Mahatma Gandhi National Institute of Medical Sciences, Jaipur	Mahatma Gandhi National Institute of Medical Sciences,Jaipur- Jaipur RAJASTHAN	0141-2771777 puneet284@rediffmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 5
Name of Committee	Approval Status
Ethics Committee of Bansal Hospital and research centre, Jaipur	Approved
Ethics Committee of LTM MC GH SION, Mumbai for Dr. NT. Awwadh.	Approved
IEC - Aditya for Dr. Jafrey	Approved
IEC - Aditya for Dr. Tushar Patel.	Approved
Institutional Ethics Committee Mahatma Gandhi Medical College and Hospital Jaipur	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	Bronchial asthma and/or chronic obstructive pulmonary disease (COPD), (1) ICD-10 Condition: J449\|\|Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J459\|\|Other and unspecified asthma,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Comparator Agent	Fixed-dose combination of Formoterol fumarate (6 µg) & Budesonide (200 µg) respicaps for Dry Powder Inhaler (DPI)	Two respicaps BD
Intervention	Fixed-dose combination of Formoterol fumarate (6 Âµg) & Mometasone furoate (200 Âµg) respicaps for Dry Powder Inhaler (DPI)	Two respicaps BD

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1.Patients between 18-65 years of age 2.Patients with an established diagnosis of bronchial asthma and/or chronic obstructive pulmonary disease (COPD) requiring a combination of long acting beta 2-agonists and inhalation corticosteroids 3.Informed consent of the patient/relative

ExclusionCriteria

Details

1. Pregnancy and/or lactation 2. Patients with severe or recently unstable bronchial asthma or status asthmaticus 3. Patients requiring nebulized therapy or oral corticosteroids 4. Patients with active or quiescent tuberculosis infection, glaucoma, untreated systemic fungal, bacterial, viral or parasitic infections or ocular herpes simplex 5. Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment 6. Patients with any significant disease of any other organ system (renal, hepatic, cardiovascular, neurologic etc.) that could interfere with the study or require treatment which might interfere with the study 7. Patients with history of known hypersensitivity to formoterol fumarate or mometasone furoate or budesonide or salbutamol or any component of the formulations 8. Patients with any other serious concurrent illness or malignancy 9. Patients with continuing history of alcohol and/or drug abuse 10. Participation in another clinical trial in the past 3 months

Method of Generating Random Sequence
Modification(s)

Computer generated randomization

Method of Concealment
Modification(s)

Centralized

Blinding/Masking
Modification(s)

Open Label

Primary Outcome
Modification(s)

Outcome	TimePoints
The degree of improvement in PEFR at each visit and at the end of the study as compared to baseline	1-4 weeks

Secondary Outcome
Modification(s)

Outcome	TimePoints
The degree of improvement in the day-time and the night-time asthma symptoms (cough, wheeze, chest tightness, and shortness of breath) score as assessed on a 4-point scale as mentioned above at each visit and at the end of the study as compared to baseline	1-4 weeks

Target Sample Size
Modification(s)

Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial
Modification(s)

Phase 3

Date of First Enrollment (India)
Modification(s)

09/03/2009

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

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination of Formoterol fumarate & Mometasone furoate Dry Powder Inhaler (DPI) and fixed-dose combination of Formoterol fumarate & Budesonide Dry Powder Inhaler (DPI) two respicaps twice daily each in 200 patients with bronchial asthma and/or chronic obstructive pulmonary disease (COPD) that will be conducted in India. The primary outcome measures will be degree of improvement in PEFR at each visit and at the end of the study as compared to baseline.