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

Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12

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

Change From Baseline in Mean ACT Score at Visit 6

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

Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12

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

Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ)

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

Correlation of Change in AQLQ Score and Change in ACT Score

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

Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12

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

Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12

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

Change From Baseline in Mean 24-hour Symptom Score at Week 12

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

Change From Baseline in Number of Additional Usage of Salbutamol at Week 12

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

Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12

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

Number of Participants With Emergency Visits Due to Asthma

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

Number of Participants With Adverse Events (AE) Leading to a Change in Asthma Treatment

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

Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE

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

Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

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

Assessment of Tolerability by Change From Baseline of Pulse Rate

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

Number of Participants With Occurrence of (Near-) Incidents Associated With Peak Flow Measurements

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