| Primary | Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths | Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods. | Safety set: The safety set included all participants who received at least one dose of study drug. | Posted | | Number | | Percentage of participants | | 337 days | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
| | | Title | Denominators | Categories |
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| Adverse events (serious and non-serious) | | | | Serious adverse events | | | | Deaths | | |
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| Secondary | Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted | Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100. | Participants from the safety set who had FEV1 percent predicted values at both baseline and the post baseline time points were analyzed at each given time point. The safety set included all participants who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period. | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Relative Change From Baseline in FVC Percent Predicted | Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted - baseline FVC % predicted) / baseline FVC % predicted) • 100. | Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period. | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted | Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100. | Participants from the safety set who had values at both baseline and the given assessment day were included in the analysis for that assessment day. Therefore, the 'n' for each assessment day is different. The safety set included all participants who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period. | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum | Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm. | Participants from the safety set who had Pa sputum density values at both baseline and the given time point were included in the analysis. The safety set included all participants who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | log10 Colony Forming Unit (CFU) | | Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337 | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa | Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested. | Participants from the safety set who had data at each time point/cycle were analyzed at each time point. The safety set included all participants who received at least one dose of study drug. | Posted | | Number | | ug/mL | | Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337 | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. Total number of isolates at each cycle/day: baseline = 279; cycle 1, day 29 = 252; cycle 2, day 85 = 238; cycle 3, day 141 = 210; cycle 4, day 197 = 184; cycle 5, day 253 = 178; cycle 6, day 309 = 164; and completion, day 337 = 158 |
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| Secondary | Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events | | Safety set: The safety set included all participants who received at least one dose of study drug. | Posted | | Number | | Percentage of participants | | Day 337 | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events | The total number of hospitalization days due to serious respiratory-related adverse events was analyzed. | Safety set: The safety set included all participants who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | Days | | Day 337 | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Time to First Hospitalization Due to Serious Respiratory-related Adverse Events | The day of first hospitalization due to serious respiratory-related adverse events was analyzed. | Safety set The safety set included all participants who received at least one dose of study drug. | Posted | | Median | 95% Confidence Interval | Days | | Day 337 | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Percentage of Participants Who Used New Anti-pseudomonal Antibiotics | | Safety set: The safety set included all participants who received at least one dose of study drug. | Posted | | Number | | Percentage of participants | | Day 337 | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Number of Days of New Anti-pseudomonal Antibiotic Use | The total number of days of new anti-pseudomonal antibiotic use was analyzed. | Safety set: The safety set included all participants who received at least one dose of study drug. | Posted | | Mean | Standard Deviation | Days | | Day 337 | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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| Secondary | Time to Use of New Anti-pseudomonal Antibiotic | Time to first use of new anti-pseudomonal antibiotic was analyzed. | Safety set The safety set included all participants who received at least one dose of study drug. | Posted | | Median | 95% Confidence Interval | Days | | Day 337 | | | | ID | Title | Description |
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| OG000 | Tobramycin Inhalation Powder (TIP) | Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. |
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