- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01069705
Second Open Label Extension to Bridging Study CTBM100C2303
May 6, 2021 updated by: Novartis Pharmaceuticals
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 Successfully Completed Participation in Study CTBM100C2303E1
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pleven, Bulgaria
- Novartis Investigative Site
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Plovdiv, Bulgaria
- Novartis Investigative Site
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Sofia, Bulgaria
- Novartis Investigative Site
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Varna, Bulgaria
- Novartis Investigative Site
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Tallin, Estonia
- Novartis Investigative Site
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Tartu, Estonia
- Novartis Investigative Site
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Riga, Latvia
- Novartis Investigative Site
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Kaunas, Lithuania
- Novartis Investigative Site
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Vilnius, Lithuania
- Novartis Investigative Site
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Bucharest, Romania
- Novartis Investigative Site
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Timisoara, Romania
- Novartis Investigative Site
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Kazan, Russian Federation
- Novartis Investigative Site
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Moscow, Russian Federation
- Novartis Investigative Site
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Saint Petersburg, Russian Federation
- Novartis Investigative Site
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Samara, Russian Federation
- Novartis Investigative Site
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Yaroslavl, Russian Federation
- Novartis Investigative Site
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Durban, South Africa
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 participants with P. aeruginosa infection.
- Forced Expiratory Volume in one second (FEV1) at screening (at start of study CTBM100C2303) must be between 25% and 80% of normal predicted values.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Tobramycin Inhalation Powder (TIPnew)
Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.
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Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Adverse Events (AEs)
Time Frame: From time of first administration of study drug until study completion (up to 169 days)
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An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not related to study drug.
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From time of first administration of study drug until study completion (up to 169 days)
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Number of Participants With Serious Adverse Events (SAEs)
Time Frame: From time of consent to 4 weeks after study completion (up to 199 days)
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A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
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From time of consent to 4 weeks after study completion (up to 199 days)
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Percentage of Participants With a Decrease of ≥20% in Forced Expiratory Value in One Second (FEV1) Percent (%) Predicted From Pre-dose to 30-minute Post-dose
Time Frame: Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7)
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Airway Reactivity >= 20% relative decrease in FEV1% predicted from pre-dose to 30 minutes post-dose.
Relative Change = 100 * (30 minutes Post-dose - Pre-dose)/Pre-dose assessed by the number and percentage of participants with a decrease of ≥ 20% in FEV1 % predicted from pre-dose to 30 minutes post-dose.
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Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7)
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Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests
Time Frame: Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Auditory acuity of participants was measured using a standard dual-channel audiometer at frequencies from 250 to 8000 Hertz, and an audiogram (pure-tone air conduction) and tympanogram were performed by an audiologist.
The categories reported includes >= 10dB decrease in 3 consecutive frequencies in either ear, >= 15dB decrease in 2 consecutive frequencies in either ear, and >= 20dB decrease in at least one frequency in either ear
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Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to Each Post-baseline Visit
Time Frame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
FEV1 % predicted was a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height.
Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) x 100.
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Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Relative Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to Each Post-baseline Visit
Time Frame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Percent Predicted Forced Vital Capacity (FVC%) is the maximal exhaled breath volume following a maximal inhaled breath.
Overall change in percent predicted FVC = (observed value)/(predicted value) * 100%.
A higher value indicates a greater response.
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Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Relative Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) Predicted to Each Post-baseline Visit
Time Frame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) is the forced expiratory flow from 25% to 75% of the Forced Vital Capacity (FVC).
Relative change in FEF25-75% from baseline to pre-dose day X = (pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100.
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Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Change From Baseline in Pseudomonas Aeruginosa Sputum Density to Each Post-baseline Visit
Time Frame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Pseudomonas Aeruginosa Density refers to overall density, defined as the sum of Biotypes (mucoid, dry and small colony variant).
Absolute change was determined using the formula; Change = Post-baseline value- baseline value.
Absolute Change in Pseudomonas Aeruginosa Sputum density is measured in log 10 Colony Forming Units per gram (Log 10 CFU/g).
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Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Change From Baseline in Tobramycin Minimum Inhibitory Concentration (MIC) Values for Pseudomonas Aeruginosa to Each Post-baseline Visit
Time Frame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Minimum Inhibitory Concentration (MIC) is defined as the lowest concentration of an antimicrobial agent required to inhibit the visible growth of a microorganism after overnight incubation.
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Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
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Number of Participants Who Used New Antipseudomonal Antibiotic During Treatment Period
Time Frame: Baseline, Cycles 5, 6, 7 (Days 1, 29)
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The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study Treatment period.
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Baseline, Cycles 5, 6, 7 (Days 1, 29)
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Percentage of Participants With Hospitalization Due to Respiratory Serious Adverse Events (SAEs)
Time Frame: From time of consent to 4 weeks after study completion (up to 199 days)
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A SAE was defined as an event which was fatal or life threatening, required or prolonged hospitalization, was significantly or permanently disabling or incapacitating, constituted a congenital anomaly or a birth defect, or encompassed any other clinically significant event that could jeopardize the participant or require medical or surgical intervention to prevent one of the aforementioned outcomes.
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From time of consent to 4 weeks after study completion (up to 199 days)
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Number of Days of Hospitalization Due to Respiratory Serious Adverse Events (SAEs)
Time Frame: From time of consent to 4 weeks after study completion (up to 199 days)
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The average number of days patients were hospitalized due to respiratory events during the study.
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From time of consent to 4 weeks after study completion (up to 199 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2010
Primary Completion (Actual)
March 19, 2012
Study Completion (Actual)
March 19, 2012
Study Registration Dates
First Submitted
February 15, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (Estimate)
February 17, 2010
Study Record Updates
Last Update Posted (Actual)
June 2, 2021
Last Update Submitted That Met QC Criteria
May 6, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTBM100C2303E2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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