| CTRI Number |
CTRI/2011/09/002020 [Registered on: 27/09/2011] Trial Registered Prospectively |
| Last Modified On: |
02/05/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis;who have completed their study participation in extension study one CTBM100C2303E1. |
|
Scientific Title of Study
|
A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Completed Participation in Study CTBM100C2303E1. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTBM100C2303E2 |
Protocol Number |
| NCT01069705 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| 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 – 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Scientific Query
|
| 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 – 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
Details of Contact Person
Public Query
|
| 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 – 400 018
Maharashtra
Mumbai
MAHARASHTRA
400 018
India |
| Phone |
022-24958545 |
| Fax |
|
| Email |
murugananthan.k@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Pharma AG, Basel, Switzerland. |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Pvt Ltd |
| Address |
Medical Dept, Sandoz House, Shiv Sagar Estate, dr A. B. road, Worli Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bulgaria
Estonia
Latvia
Lithuania
Romania
Russian Federation
South Africa |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr D J Christopher |
Christian Medical College |
Prof and Head,
Department of Pulmonary Medicine,Ida Scudder Road
Vellore - 632004
Vellore
TAMIL NADU |
919443306573
00914162211570
pulmedcmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board / Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pulmonary Infections
Pseudomonas Aeruginosa
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Compartor Agent |
- |
| Intervention |
Tobramycin inhalation powder |
Tobramycin inhalation powder provided in hard-capsules, each containing 28 mg active
ingredient powder, which themselves are packaged in blisters. Capsules are to be administered
using the T-326 inhaler.
dose regimen for the test product is four capsules of TIP at 28 mg dosage
strength, inhaled b.i.d. in the morning and in the evening, for 28 days (on treatment), followed
by 28 days of no study treatment (off treatment). These 56 days represent 1 cycle of therapy.
Each subject shall undergo 3 cycles of treatment |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 took place not more than 5 days before enrollment into this study
Confirmed diagnosis of cystic fibrosis patients with P. aeruginosa infection.
FEV1 at screening (at start of study CTBM100C2303) must be between 25 percentage and 80 percentage of normal predicted values.
|
|
| ExclusionCriteria |
| Details |
Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial CTMB100C2303E1 and the enrollment into this study.
Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Safety of tobramycin inhalation powder for the treatment of infections with P. aeruginosa in patients suffering from cystic fibrosis. |
Each visit during the 168-day treatment period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Efficacy of tobramycin inhalation powder, assessed by FEV1 , FVC and FEF25-75 profile.
2.Density of microorganisms in sputum samples |
1.Each visit during the 168-day treatment period.
2.Each visit during the 168-day treatment period |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="1"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
15/02/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publications provided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of Study: This is an open-label, single arm (uncontrolled) study in patients suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 (CTRI/2010/091/001399) and extension study one CTBM100C2303E1(CTRI/2011/04/001664) (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.
FPFV: 19-Sept-2011
Enrollment Target for India: 01 |