Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in R5 from baseline at Week 4. |
Estimate the difference in airway resistance measured at the 5 Hz frequency (R5) from the initial measurement (baseline) to the measurement taken after four weeks |
4 weeks |
|
Primary |
Change in R20 from baseline at Week 4. |
Estimate the difference in airway resistance measured at the 20 Hz frequency (R20) from the initial measurement (baseline) to the measurement taken after four weeks |
4 weeks |
|
Primary |
Change in R5-R20 from baseline at Week 4. |
Estimate the difference in small airway resistance (R5- R20) from the initial measurement (baseline) to the measurement taken after four weeks |
4 weeks |
|
Primary |
Change in AX from baseline at Week 4 |
Estimate the difference in AX from the initial measurement (baseline) to the measurement taken after four weeks |
4 weeks |
|
Primary |
Change in Fres from baseline at Week 4. |
Estimate the difference in Fres from the initial measurement (baseline) to the measurement taken after four weeks |
4 weeks |
|
Primary |
Change in X5 from baseline at Week 4. |
Estimate the difference in X5 from the initial measurement (baseline) to the measurement taken after four weeks |
4 weeks |
|
Primary |
Change in R5 from baseline at Week 12 |
Estimate the difference in airway resistance measured at the 5 Hz frequency (R5) from the initial measurement (baseline) to the measurement taken after 12 weeks |
12 weeks |
|
Primary |
Change in R20 from baseline at Week 12 |
Estimate the difference in airway resistance measured at the 20 Hz frequency (R20) from the initial measurement (baseline) to the measurement taken after 12 weeks |
12 weeks |
|
Primary |
Change in R5-R20 from baseline at Week 12 |
Estimate the difference in small airway resistance (R5-R20) from the initial measurement (baseline) to the measurement taken after 12 weeks |
12 weeks |
|
Primary |
Change in AX from baseline at Week 12 |
Estimate the difference in AX from the initial measurement (baseline) to the measurement taken after 12 weeks |
12 weeks |
|
Primary |
Change in Fres from baseline at Week 12 |
Estimate the difference in Fres from the initial measurement (baseline) to the measurement taken after 12 weeks |
12 weeks |
|
Primary |
Change in X5 from baseline at Week 12 |
Estimate the difference in X5 from the initial measurement (baseline) to the measurement taken after 12 weeks |
12 weeks |
|
Primary |
Change in R5 from baseline at Week 26. |
Estimate the difference in airway resistance measured at the 5 Hz frequency (R5) from the initial measurement (baseline) to the measurement taken after 26 weeks |
26 weeks |
|
Primary |
Change in R20 from baseline at Week 26. |
Estimate the difference in airway resistance measured at the 20 Hz frequency (R20) from the initial measurement (baseline) to the measurement taken after 26 weeks |
26 weeks |
|
Primary |
Change in R5-R20 from baseline at Week 26. |
Estimate the difference in small airway resistance (R5-R20) from the initial measurement (baseline) to the measurement taken after 26 weeks |
26 weeks |
|
Primary |
Change in AX from baseline at Week 26. |
Estimate the difference in AX from the initial measurement (baseline) to the measurement taken after 26 weeks |
26 weeks |
|
Primary |
Change in Fres from baseline at Week 26. |
Estimate the difference in Fres from the initial measurement (baseline) to the measurement taken after 26 weeks |
26 weeks |
|
Primary |
Change in X5 from baseline at Week 26. |
Estimate the difference in X5 from the initial measurement (baseline) to the measurement taken after 26 weeks |
26 weeks |
|
Secondary |
Compare the changes in IOS parameters with spirometric parameters at Week 4 |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with spirometric parameters (FEV1, FEV1%, FVC, FVC%, FEV1/FVC, PEF, PEF%, FEF25, FEF25%, FEF75, FEF75%, FEF25-75, FEF25-75%) at Weeks 4 |
4 weeks |
|
Secondary |
Compare the changes in IOS parameters with spirometric parameters at Week 12 |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with spirometric parameters (FEV1, FEV1%, FVC, FVC%, FEV1/FVC, PEF, PEF%, FEF25, FEF25%, FEF75, FEF75%, FEF25-75, FEF25-75%) at Week 12 |
12 weeks |
|
Secondary |
Compare the changes in IOS parameters with spirometric parameters at Week 26 |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with spirometric parameters (FEV1, FEV1%, FVC, FVC%, FEV1/FVC, PEF, PEF%, FEF25, FEF25%, FEF75M FEF75%, FEF25-75, FEF25-75%) at Week 26 |
26 weeks |
|
Secondary |
Compare the changes in IOS parameters with constant volume plethysmograph parameters at Week 4. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with spirometric parameters (RV. RV%, TLC, TLC%, RV/TLC) at Week 4 |
4 weeks |
|
Secondary |
Compare the changes in IOS parameters with constant volume plethysmograph parameters at Week 12. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with spirometric parameters (RV. RV%, TLC, TLC%, RV/TLC) at Week 12 |
12 weeks |
|
Secondary |
Compare the changes in IOS parameters with constant volume plethysmograph parameters at Week 26. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with spirometric parameters (RV. RV%, TLC, TLC%, RV/TLC) at Week 26 |
26 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in 5-item Asthma Control Questionnaire (ACQ-5) at Week 4. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in 5-item Asthma Control Questionnaire (ACQ-5) at Week 4. |
4 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in 5-item Asthma Control Questionnaire (ACQ-5) at Week 12. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in 5-item Asthma Control Questionnaire (ACQ-5) at Week 12. |
12 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in 5-item Asthma Control Questionnaire (ACQ-5) at Week 26. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in 5-item Asthma Control Questionnaire (ACQ-5) at Week 26. |
26 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in Asthma Control Test (ACT) at Week 4. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in 5-item Asthma Control Test (ACT) at Week 4. |
4 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in the Asthma Control Test (ACT) at Week 12. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in the 5-item Asthma Control Test (ACT) at Week 12. |
12 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in the Asthma Control Test (ACT) at Week 26. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in the 5-item Asthma Control Test (ACT) at Week 26. |
26 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in the Asthma Quality of Life Questionnaire (AQLQ) at Week 4. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in the Asthma Quality of Life Questionnaire (AQLQ) at Week 4. |
4 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in the Asthma Quality of Life Questionnaire (AQLQ) at Week 12. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in the Asthma Quality of Life Questionnaire (AQLQ) at Week 12. |
12 weeks |
|
Secondary |
Compare the changes in IOS parameters with the changes in the Asthma Quality of Life Questionnaire (AQLQ) at Week 26. |
To compare the changes in IOS parameters (R5, R20, R5-R20, AX, Fres, X5) with the changes in the Asthma Quality of Life Questionnaire (AQLQ) at Week 26. |
26 weeks |
|