CTRI Trial Data

PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 14:49:48 GMT)

CTRI Number CTRI/2014/02/004432 [Registered on: 25/02/2014] - Trial Registered Retrospectively Last Modified On 24/02/2014 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Non-randomized, Placebo Controlled Trial Public Title of Study Study to assess the confidence, usability, preference and satisfaction on use of Zerostat-VT Spacer in healthy volunteers and in subjects with mild asthama or COPD Scientific Title of An open, prospective, single centre study to assess the confidence, usability, preference and Study satisfaction on use of Zerostat-VT Spacer in healthy volunteers and in subjects with mild asthama or COPD Secondary IDs if Any Secondary ID Identifier CP/20/10 Version No.2 Date:January 21,2011 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sundeep Salvi Trial Coordinator (multi-center study) Designation Director Affiliation Chest Research Foundation Address Chest Research Foundation, Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune Pune MAHARASHTRA 411014 India Pune MAHARASHTRA 411014 India Phone 09921211000 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Jaideep A Gogtay Query) Designation Chief Medical Officer Affiliation Cipla Ltd. Address Cipla Ltd. Bellasis Road, Mumbai Central Mumbai MAHARASHTRA 400 008 India Phone 022-23025412 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Ms Pallavi Phopale Designation Sponsor’s Monitor Affiliation Address Cipla Ltd., Raj Plaza, LBS marg, Vikhroli Mumbai MAHARASHTRA 400 083 India

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Phone 02225787825 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Cipla Ltd, Bellasis Road, Mumbai Central, Mumbai, Phone 02223082891 Fax 02225787855 Primary Sponsor Primary Sponsor Details Name Cipla Ltd Address Bellasis Road, Mumbai Central, Mumbai, Phone : (022) 23082891 Fax : (022)25787855 Type of Sponsor Pharmaceutical industry-Indian Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sundeep Salvi Chest Research Chest Research 09921211000 Foundation, Pune Foundation, Marigold Premises, Survey [email protected] No.15, Vadgaon Sheri, Kalyani Nagar, Pune Pune MAHARASHTRA 411014 India Pune MAHARASHTRA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Independent Ethics Approved 05/02/2011 Yes Committee Primarily Associated With Chest Research Foundation Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients subjects with mild asthma or COPD Intervention / Type Name Details Comparator Agent Intervention Zerostat VT spacer with Placebo pMDI (Pressurized Placebo pMDI Metered Dose Inhaler) with Zerostat-VT spacer device used for 3 consecutive inhalation attempts Comparator Agent Not Applicable Not Applicable Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 99.00 Year(s) Gender Both Details 1. Subjects and healthy volunteers willing to sign ethics committee
approved informed consent form.
2. Subjects and healthy volunteers of 18 years and above.
3. Subjects with or without a respiratory condition. Each subject with a

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respiratory condition (prior experience of using a device) should be
matched as far as possible with an individual without a respiratory
condition (device naive) with respect to the age, sex, literacy status
etc.
4. Subjects with mild Asthma or COPD or healthy volunteer. Exclusion Criteria Exclusion Criteria Details 1. Subjects already using Zerostat-VT spacer prior to start of the study. 2. Subjects with co-ordination problems like Parkinson’s disease, mental illness, tremors etc. Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Average time taken for 3 consecutive correct During First and second visit attempts

Secondary Outcome Outcome Timepoints Number of attempts required to achieve first At baseline and follow-up visit correct attempt Type and number of errors During first and second visit Confidence, Usability, Preference, Satisfaction Throughout the study assessment Target Sample Size Total Sample Size=30 Sample Size from India=30 Final Enrollment numbers achieved (Total)= Final Enrollment numbers achieved (India)= Phase of Trial Phase 4 Date of First 25/02/2011 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=2 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details None Brief Summary

This is a phase-IV single centre study which will be conducted in healthy volunteers and in subjects with mild asthma or COPD for the assessment of confidence, usability, preference and satisfaction on use of Zerostat-VT through a questionnaire. During the treatment period subject will complete two visits. On this basis an average time taken by the subject for 3 consecutive correct attempts during the first and second visit will be analyzed. During first and second visit type and number of errors will be determined. For safety assessment of the trial participants incidence and nature of adverse events will be done through out the entire treatment period.

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