| Primary | Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period | Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary. | Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations | Posted | | Mean | Standard Deviation | percentage of days | | Last 10 weeks of the treatment period (Weeks 16-26) | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00050.45± 33.52
- OG00149.75± 35.77
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Repeated Measurements Anal. of Variance | | 0.63 | | Adjusted difference | 2.6 | | | | 95 | -8.1 | 13.4 | | | | | Non-Inferiority or Equivalence | Non-inferiority is considered to be shown if the upper limit of the one-sided 95% confidence interval of the difference uflixotide-useretide does not exceed +15% (uflixotide-useretide represent the mean percentages of asthma symptom-free days of the two respective treatment groups). | |
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| Secondary | Percentage of Symptom-free Days During the Entire Treatment Period | Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary | Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations | Posted | | Mean | Standard Deviation | percentage of days | | Baseline to Week 26 | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26 | Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age. | Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis. | Posted | | Mean | Standard Deviation | percent predicted change | | Baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26 | Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility. | Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis. | Posted | | Mean | Standard Deviation | liters | | Baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26 | Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility. | Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. For some participants, the data for the MEF 50 measurements are missing, resulting in a smaller number of participants analyzed. | Posted | | Mean | Standard Deviation | liters/second | | Baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Geometric Means of Nitric Oxide (NO) at Week 26 | Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables. | Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26) | Posted | | Geometric Mean | Full Range | parts per billion | | Baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Percent Change From Baseline in RINT Measurements at Week 26 | Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test. | PP Population: Intent-to-Treat (ITT) Population participants who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26). For some participants, the data for the RINT measurement are missing, either at Baseline or at Week 26. As a result, fewer subjects have been included in the analysis. | Posted | | Number | | percent | | Baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Number of Asthma Exacerbations Per Treatment Group at Week 26 | An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication. | Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) | Posted | | Number | | number of exacerbations | | Week 26 | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26 | PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values. | Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. From this population, only participants who had measurements at both baseline and Week 26 have been used for analysis. | Posted | | Log Mean | 95% Confidence Interval | ratio | | Baseline and Week 26 | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres | Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment. | | Posted | | | | | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1) | Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis. | | Posted | | | | | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Frequency of Asthma Exacerbations (Discriminated on Severity) | The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency. | | Posted | | | | | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Cumulative Number of Symptom-free Weeks Until the End of Treatment | This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used. | | Posted | | | | | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks' | This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used. | | Posted | | | | | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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| Secondary | Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week' | This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used. | | Posted | | | | | | 26 weeks | | | | ID | Title | Description |
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| OG000 | Salmeterol/FP 50/100 mcg Plus Placebo | Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler | | OG001 | FP 200 mcg | FP 200 mcg BID via DISKUS inhaler |
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