| Primary | Number of Participants With Adverse Events (AEs) | 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. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. | Posted | | Count of Participants | | Participants | | From time of first administration of study drug until study completion (up to 169 days) | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Number of Participants With Serious Adverse Events (SAEs) | 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. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. | Posted | | Count of Participants | | Participants | | From time of consent to 4 weeks after study completion (up to 199 days) | | | | ID | Title | Description |
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| OG000 | 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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| Primary | 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 | 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. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Number | | percentage of participants | | Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7) | | | | ID | Title | Description |
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| OG000 | 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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| Primary | Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests | 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 | All participants included in the safety population with at least one audiology testing. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Number | | percentage of participants | | Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to Each Post-baseline Visit | 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. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Mean | Standard Deviation | percent change in FEV1 % predicted | | Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Relative Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to Each Post-baseline Visit | 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. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Mean | Standard Deviation | percent change in FVC % predicted | | Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Relative Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) Predicted to Each Post-baseline Visit | 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. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Mean | Standard Deviation | percent change in (FEF25-75)% predicted | | Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Change From Baseline in Pseudomonas Aeruginosa Sputum Density to Each Post-baseline Visit | 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). | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Mean | Standard Deviation | Log 10 CFU/g | | Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Change From Baseline in Tobramycin Minimum Inhibitory Concentration (MIC) Values for Pseudomonas Aeruginosa to Each Post-baseline Visit | 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. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Mean | Standard Deviation | microgram/millilitre | | Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Number of Participants Who Used New Antipseudomonal Antibiotic During Treatment Period | The rate of anti-pseudomonal antibiotics use were determined from the collection of concomitant medication during the study Treatment period. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. | Posted | | Count of Participants | | Participants | | Baseline, Cycles 5, 6, 7 (Days 1, 29) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Percentage of Participants With Hospitalization Due to Respiratory Serious Adverse Events (SAEs) | 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. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Number | | percentage of participants | | From time of consent to 4 weeks after study completion (up to 199 days) | | | | ID | Title | Description |
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| OG000 | 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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| Secondary | Number of Days of Hospitalization Due to Respiratory Serious Adverse Events (SAEs) | The average number of days patients were hospitalized due to respiratory events during the study. | Safety population included all participants who completed their participation in C2303E1, who gave their consent to enter the extension 2 study and who received at least one dose of study drug in the extension 2 study. Number analyzed is the number of participants with data available at the given timepoint. | Posted | | Mean | Standard Deviation | days | | From time of consent to 4 weeks after study completion (up to 199 days) | | | | ID | Title | Description |
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| OG000 | 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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