Trial Outcomes & Findings for Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data (NCT NCT00363480)

NCT ID: NCT00363480

Last Updated: 2018-03-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 221 participants
• Primary outcome timeframe: Week 9 to Week 12
• Results posted on: 2018-03-09

Participant Flow

Study was conducted at 27 centers in Germany from 17 May 2006 to 6 September 2007 on participants diagnosed with perennial bronchial asthma.

A total of 261 participants were screened, of which 40 were screen failure, remaining 221 participants entered the treatment period.

Participant milestones

Measure	SFC 50/250 mcg Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Overall Study STARTED	221
Overall Study COMPLETED	204
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	SFC 50/250 mcg Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Overall Study Criteria for treatment period not fulfil	1
Overall Study Adverse Event	4
Overall Study Lost to Follow-up	5
Overall Study Withdrawal by Subject	5
Overall Study Non-compliance of subject	1
Overall Study Participant discontinued on its own	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SFC 50/250 mcg n=221 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Age, Continuous	49.5 Years STANDARD_DEVIATION 15.5 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants
Sex: Female, Male Male	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	SFC 50/250 mcg n=170 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12 GOAL	33.5 Percentage
Percentage of Well Controlled Participants as Per Gaining Optimal Asthma Control (GOAL) Criteria After 12 Week Compared to Percentage of Participants With Asthma Control Test (ACT) Score of 20-25 for Week 9 to Week 12 ACT	64.1 Percentage

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	SFC 50/250 mcg n=213 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12 Baseline	32 Participants
Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12 Week 12	139 Participants

SECONDARY outcome

Timeframe: Baseline (Viait 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.

Outcome measures

Measure

SFC 50/250 mcg n=203 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

Change From Baseline in Mean ACT Score at Visit 6

5.0 Score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Week 12

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

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.

Outcome measures

Measure	SFC 50/250 mcg n=217 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12 Well Controlled	65 Participants Interval 23.0 to 36.0
Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12 Totally Controlled	29 Participants

SECONDARY outcome

Timeframe: Baseline (Visit 3) up to Week 12

Population: Full Analysis Set. 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.

Outcome measures

Measure

SFC 50/250 mcg n=188 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

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

0.83 Score on Scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure

SFC 50/250 mcg n=217 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

Correlation of Change in AQLQ Score and Change in ACT Score

0.522 participants

SECONDARY outcome

Timeframe: Baseline (Visit 3) up to Week 12

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

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.

Outcome measures

Measure	SFC 50/250 mcg n=217 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12 Week 4	0.133 Litre/second (L/Sec) Standard Deviation 0.320
Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12 Week 8	0.212 Litre/second (L/Sec) Standard Deviation 0.359
Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12 Week 12	0.181 Litre/second (L/Sec) Standard Deviation 0.372

SECONDARY outcome

Timeframe: Baseline (Visit 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.

Outcome measures

Measure

SFC 50/250 mcg n=194 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

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

7.798 Percentage Standard Deviation 10.302

SECONDARY outcome

Timeframe: Baseline (Visit 3) and 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.

Outcome measures

Measure

SFC 50/250 mcg n=191 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

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

-0.590 Score on Scale Standard Deviation 0.948

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure

SFC 50/250 mcg n=190 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

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

-0.933 Number of occassions Standard Deviation 1.331

SECONDARY outcome

Timeframe: Baseline (Visit 3) and 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.

Outcome measures

Measure

SFC 50/250 mcg n=182 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

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

7.228 Percent Change Standard Deviation 24.921

SECONDARY outcome

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

Outcome measures

Measure	SFC 50/250 mcg n=202 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Number of Participants With Emergency Visits Due to Asthma At least 1 day	13 Participants
Number of Participants With Emergency Visits Due to Asthma 1 day	10 Participants
Number of Participants With Emergency Visits Due to Asthma 2 days	2 Participants
Number of Participants With Emergency Visits Due to Asthma 3-4 days	1 Participants
Number of Participants With Emergency Visits Due to Asthma 5-9 days	0 Participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety Set.

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.

Outcome measures

Measure

SFC 50/250 mcg n=221 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

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

4 Participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety Set.

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.

Outcome measures

Measure	SFC 50/250 mcg n=221 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE Any Serious AE	1 Participants
Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE Any Non-Serious AE	76 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	SFC 50/250 mcg n=221 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 4	0.8 millimeters of mercury (mmHg) Standard Deviation 12.7
Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 8	-0.7 millimeters of mercury (mmHg) Standard Deviation 11.3
Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP, Week 12	0.2 millimeters of mercury (mmHg) Standard Deviation 13.5
Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 4	0.2 millimeters of mercury (mmHg) Standard Deviation 8.8
Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 8	-0.2 millimeters of mercury (mmHg) Standard Deviation 8.4
Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP, Week 12	0.6 millimeters of mercury (mmHg) Standard Deviation 9.0

SECONDARY outcome

Timeframe: Baseline (Visit 3) up to Week 12

Population: Safety Set. Only those participants available at the specified 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.

Outcome measures

Measure	SFC 50/250 mcg n=221 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Assessment of Tolerability by Change From Baseline of Pulse Rate Week 8	-0.2 Beats per minute (bpm) Standard Deviation 9.1
Assessment of Tolerability by Change From Baseline of Pulse Rate Week 12	0.6 Beats per minute (bpm) Standard Deviation 10.2
Assessment of Tolerability by Change From Baseline of Pulse Rate Week 4	1.0 Beats per minute (bpm) Standard Deviation 9.0

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety Set.

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

Outcome measures

Measure

SFC 50/250 mcg n=221 Participants Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.

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

0 participants

Adverse Events

SFC 50/250 mcg

Serious events: 1 serious events

Other events: 76 other events

Deaths: 1 deaths

Serious adverse events

Measure	SFC 50/250 mcg n=221 participants at risk Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.

Other adverse events

Measure	SFC 50/250 mcg n=221 participants at risk Participants received SFC 50/250 mcg for 12 weeks. Study treatment was received using DISKUS powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Cardiac disorders Angina pectoris	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Cardiac disorders Tachycardia	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Ear and labyrinth disorders Ear pain	0.90% 2/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Ear and labyrinth disorders Sudden hearing loss	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Ear and labyrinth disorders Vertigo	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Eye disorders Conjunctivitis allergic	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Eye disorders Lacrimation increased	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Gastrointestinal disorders Toothache	1.4% 3/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Gastrointestinal disorders Abdominal pain upper	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Gastrointestinal disorders Gingivitis	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Gastrointestinal disorders Stomatitis	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
General disorders Pyrexia	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
General disorders General physical health deterioration	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
General disorders Local swelling	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
General disorders Chest pain	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Immune system disorders Hypersensitivity	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Gastrointestinal infection	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Borrelia infection	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Candidiasis	0.90% 2/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Oral candidiasis	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Otitis externa	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Respiratory tract infection	2.7% 6/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Bronchitis	5.4% 12/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Nasopharyngitis	8.1% 18/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Sinusitis	2.7% 6/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Upper respiratory tract infection	0.90% 2/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Acute sinusitis	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Laryngitis	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Infections and infestations Rhinitis	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Injury, poisoning and procedural complications Epicondylitis	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Injury, poisoning and procedural complications Arthropod bite	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Investigations Blood uric acid increased	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Musculoskeletal and connective tissue disorders Arthralgia	1.4% 3/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Musculoskeletal and connective tissue disorders Muscle spasms	0.90% 2/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Musculoskeletal and connective tissue disorders Back pain	2.3% 5/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Musculoskeletal and connective tissue disorders Pain in extremity	1.8% 4/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Nervous system disorders Headache	10.4% 23/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Psychiatric disorders Sleep disorder	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Respiratory, thoracic and mediastinal disorders Asthma	3.6% 8/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Respiratory, thoracic and mediastinal disorders Cough	1.4% 3/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Skin and subcutaneous tissue disorders Erythema	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Skin and subcutaneous tissue disorders Pruritus generalised	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Skin and subcutaneous tissue disorders Urticaria	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.
Vascular disorders Hypertension	0.45% 1/221 • Up to Week 12 The AE and SAEs were recorded using safety set of population.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER