Second Open Label Extension to Bridging Study CTBM100C2303
- Conditions
- Pseudomonas AeruginosaPulmonary Infections
- Interventions
- Registration Number
- NCT01069705
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tobramycin Inhalation Powder (TIPnew) Tobramycin inhalation powder 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) From time of first administration of study drug until study completion (up to 169 days) 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.
Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) 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
Number of Participants With Serious Adverse Events (SAEs) From time of consent to 4 weeks after study completion (up to 199 days) 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.
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 Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Used New Antipseudomonal Antibiotic During Treatment Period Baseline, Cycles 5, 6, 7 (Days 1, 29) The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study Treatment period.
Percentage of Participants With Hospitalization Due to Respiratory Serious Adverse Events (SAEs) From time of consent to 4 weeks after study completion (up to 199 days) 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.
Number of Days of Hospitalization Due to Respiratory Serious Adverse Events (SAEs) From time of consent to 4 weeks after study completion (up to 199 days) The average number of days patients were hospitalized due to respiratory events during the study.
Relative Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to Each Post-baseline Visit Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) 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.
Change From Baseline in Pseudomonas Aeruginosa Sputum Density to Each Post-baseline Visit Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) 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).
Change From Baseline in Tobramycin Minimum Inhibitory Concentration (MIC) Values for Pseudomonas Aeruginosa to Each Post-baseline Visit Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) 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.
Relative Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) Predicted to Each Post-baseline Visit Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) 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.
Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to Each Post-baseline Visit Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) 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.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇿🇦Durban, South Africa