| CTRI Number |
CTRI/2010/091/001399 [Registered on: 09/11/2010] |
| Last Modified On: |
01/10/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo (EDIT) |
Scientific Title of Study
Modification(s)
|
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew). |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CTBM100C2303 |
Protocol Number |
| NCT00918957 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Head- Clincal Development |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai.
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Murugananthan K |
| Designation |
Head- Clinical Development |
| Affiliation |
|
| Address |
Novartis Healthcare Private Limited,
Medical Department,
Sandoz House,
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Shiv Sagar Estate,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
02224958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novartis Pharma AG , Basel, Switzerland |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis HealthCare Pvt Ltd |
| Address |
Medical Dept,Sandoz house, Shiv Sagar Estate, Dr. Annie Besant road, Worli, Mumbai-400018 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
Egypt
Estonia
India
Latvia
Russian Federation |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. S. K. Kabra |
AIIMS |
Department of Pediatrics,-110 029
New Delhi
DELHI |
011-26593621
skkabra@hotmail.com |
| Dr. D. J. Christopher |
Christian Medical College |
Department of Pulmonary ,-632 004
Vellore
TAMIL NADU |
+91-416-2283373
00-91-416-2211570
pulmedcmc@gmail.com |
| Dr. Pradyut Waghray |
Kunal Institute of Medical Specialities Pvt Ltd |
5-9-41/1/A,,New MLA Quarters Lane, Basheer Bagh, -500 029
Hyderabad
ANDHRA PRADESH |
+91-40-23236243
040-23236243
kimschest@rediffmail.com |
| Dr Meenu Singh |
Postgraduate Institute of Medical Education & Research |
Additional Professor
Pediatrics, Advanced Pediatrics Centre,
Chandigarh-160012
Chandigarh
CHANDIGARH |
0172-2755306
meenusingh4@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Cerebral Independent Review Board, Hyderabad, Dr.Pradyut Waghrey |
Approved |
| Institute Ethics Committee, PGIMER |
Approved |
| Institution Ethics Committee, New Delhi |
Submittted/Under Review |
| Institutional Review Board, Christian Medical College, Vellore |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Cystic Fibrosis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Comparator:
placebo capsules (DSPC/CaCl2). |
four capsules, inhaled b.i.d. in the morning and in the evening, using the T-326
inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). These 56
days represent 1 cycle of therapy. same followed for during the entire treatment duration. |
| Intervention |
TIP new: Experimental |
Tobramycin Inhalation Powder
Tobramycin Inhalation Powder as produced by a modified manufacturing process (TIP new)
|
|
Inclusion Criteria
Modification(s)
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| Age From |
6.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
. Written informed consent given by adult subjects or by the parents/legal guardian on behalf of the
subject in combination with the subject’ s assent, if capable of assenting, before any assessment
is performed.
• Confirmed diagnosis of CF by the presence of one or more clinical features of CF in addition to
o a quantitative pilocarpine iontophoresis sweat chloride test of > 60 mEq/L; or
o identification of well-characterized disease-causing mutations in each CFTR gene; or
o an abnormal nasal transepithelial potential difference characteristic of CF.
• Male and female subjects aged 6 years to 21 years of age at the time of screening.
• FEV1 at screening must be ≥ 25% and ≤ 80% of normal predicted values for age, sex, and height
based on Knudson criteria.
• P. aeruginosa must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar
lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab
culture at the screening visit.
• Able to expectorate a sputum sample or to provide a deep-throat cough swab at screening.
• Able to comply with all protocol requirements.
• Use of an effective means of contraception in females of childbearing potential.
• Clinically stable in the opinion of the investigator to be treated according to this protocol.
|
|
| ExclusionCriteria |
| Details |
* Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening.
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Other protocol-defined inclusion/exclusion criteria apply.
|
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Centralized |
Blinding/Masking
Modification(s)
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Relative change from baseline FEV1 percent predicted compared to placebo |
Day 29 of on-treatment period of cycle 1 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Safety profile of TIPnew |
As reported until 4 weeks post study |
| Pharmacokinetic properties of tobramycin from TIPnew |
Days 1 and 29 |
| Density of microorganisms in sputum samples |
Day 1, 29, 57 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="100"
Sample Size from India="1"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
07/01/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/05/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No Publication provided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Purpose of the study:
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
Target number of patients from India is1.
Anticipated date of enrollment for the Indian arm is 15 Oct 2010. |