Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data

A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score \>1 (Range: 0= None to 5= severe), rescue salbutamol use on \<= 2 days and at most 4 occasions per week, and a morning peak flow \>= 80% of the predicted value on each day per week. All of the criteria which includes no night-time awakenings due to asthma (diary entry), no emergency visits (diary entry), no exacerbations and no treatment-related adverse events leading to treatment change are fulfilled. The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control.

Time frame: Week 9 to Week 12

Population: Modified Intent-to-Treat population, participants covering treatment period of at least 8 weeks and with assessable asthma control at the end of the treatment period by both criteria (GOAL, ACT), and without major protocol deviations. Only those participants available at the indicated time points were analyzed.

Pulse rate was recorded over time (Visit 1, 3, 4, 5, and 6). Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.

Time frame: Baseline (Visit 3) up to Week 12

Population: Safety Set. Only those participants available at the specified time points were analyzed.

SBP and DBP were recorded over time (Visit 1, 3, 4, 5, and 6). Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.

Time frame: Baseline (Visit 3) up to Week 12

Population: Safety Set. Only those participants available at the specified time points were analyzed.

An AE is any untoward medical occurrence in a participant or clinical AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. Number of participants with at least one treatment emergent serious and, non-serious AE were reported.

Time frame: Up to Week 12

Population: Safety Set.

FEV1, an amount of air exhaled by a person during a forced breath in one second. FEV1 assessed at Visit 1 and at Visits 3, 4, 5, 6. Baseline was the measurement at Visit 3. Change from baseline value was calculated by subtracting baseline value from week 12 value.

Time frame: Baseline (Visit 3) up to Week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.

The various symptoms like wheezing, shortness of breath, coughing and chest tightness were assessed by the participants every morning using a symptom score scale which ranged from 0 (no symptoms during the past 24 hours) to 5 (symptoms so severe that participant could not go to work or carry out other normal daily activities). Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Time frame: Baseline (Visit 3) and Week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.

The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms not under control. In order to derive the total ACT score, all 5 questions had to be answered. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Time frame: Baseline (Viait 3) and Week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.

PEF, a person's maximum speed of expiration, as measured with a peak flow meter, a small, hand-held device used to monitor a person's ability to breathe out air. The mean morning PEF evaluated by means of the data documented in the asthma diaries. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Time frame: Baseline (Visit 3) and Week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.

Salbutamol was given as a rescue medicine, used on \<= 2 days and at most 4 occasions per week. Change from baseline value was calculated by subtracting the baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Time frame: Baseline (Visit 3) and week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.

The total ACT score is based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control. In order to derive the total ACT score, all 5 questions needed to be answered. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Time frame: Baseline (Visit 3) and Week 12

Population: Full Analysis Set comprised of all participants with at least one post-baseline (Visit 3) efficacy measurement during clinic visits (Visit 4, 5, 6) or valid diary data documented for at least one week post-baseline was included. Only those participants available at the indicated time points were analyzed.

For the level of asthma control, baseline values were derived taking the last 8 weeks during the pre-treatment period prior to Visit 3 into consideration. Regarding derived variables based on the asthma diary, data from the last week prior to Visit 3 was taken. Visit 3, regarded as baseline. AQLQ has 32 questions regarding activities, emotions, symptoms, and environmental triggers. Each item values range from 1 (maximum impairment) to 7 (no impairment). A positive change from baseline score indicates improvement.

Time frame: Baseline (Visit 3) up to Week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.

Correlation between change in the AQLQ and ACT score was tabulated using the Pearson coefficient of correlation (linear correlation). The AQLQ contained 32 items in 4 domains: activity limitation, symptoms, emotional function and environmental stimuli. Scores for the domains as well as the overall score were scaled within a range of 1 (worst) to 7 (best).

Time frame: Week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.

AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. Number of participants with AE who lead to change in asthma treatment were reported.

Time frame: Up to Week 12

Population: Safety Set.

Frequencies of emergency visits per participant were recorded during treatment period. Only the participants at risk were considered when calculating the incidence rates.

Time frame: Up to week 12

Population: Safety set comprised of participants who received study medication at least once s participants who did not administer any study medication (those who returned all study medication dispensed) were not included in the Safety Set. Only those participants available at the indicated time points were analyzed.

Frequencies of participants with at least one (near-) incident associated with peak flow measurements were recorded. analysis was done on safety population.

Time frame: Up to Week 12

Population: Safety Set.

Well controlled or totally controlled asthma assessments were done according to the GOAL criteria. A week with well controlled asthma, when two or more of the criteria were fulfilled (diary entries): At most 2 days per week with 24-hour symptom score \>1(Range: 0= None to 5= severe), rescue salbutamol use on \<= 2 days and at most 4 occasions per week, and morning peak flow \>= 80% of the predicted value on each day per week. All of the criteria which included no night-time awakenings due to asthma (diary entry),no emergency visits (diary entry), no exacerbations and no treatment-related adverse events leading to treatment change were fulfilled. The total ACT score was based on a range of 5 to 25. Higher score indicates better asthma control. A score of 19 or less may be a sign that asthma symptoms are not under control. Change from baseline value was calculated by subtracting baseline value from week 12 value. The assessments recorded at Visit 3 were considered as Baseline assessments.

Time frame: Week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.

Number of nights with no night time awakening were recorded at Week 12. Baseline was the last corresponding time period immediately prior to Visit 3.

Time frame: Baseline (Visit 3) and week 12

Population: Full Analysis Set. Only those participants available at the indicated time points were analyzed.