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

Asthma Clinical Trial

Official title:

Asthma Control Assessment Via ACT and DRC in Asthmatics Treated With Seretide (50/250) Over 12 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363480
• Other study ID #: SAM 106538
• Status: Completed
• Phase: Phase 4
• First received: August 10, 2006
• Last updated: March 6, 2018
• Start date: May 17, 2006
• Est. completion date: September 14, 2007

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients.

The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: September 14, 2007
• Est. primary completion date: September 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Diagnosis of asthma

• Reversibility >12% after inhalation of 200 µg Salbutamol

• willingness and ability to complete daily record card on daily basis and to measure morning PEF on daily basis

• 80% compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria

Exclusion criteria:

• Change of asthma medication during the last 4 weeks

• Asthma exacerbation characterized by use of oral corticoids during the last 3 months Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or equivalent per day or other controller therapy during the last 3 months

• upper or lower respiratory tract infection during the RUN-IN period moderate or severe asthma exacerbation during the RUN-IN period

• Non compliance with use of Discus, PEF-meter and incomplete diary card data

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol/Fluticasone 50/250 mcg
Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.
• Salbutamol 100 mcg
This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol.

Device:
• DISKUS™ powder inhalers
Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Bad Arolsen	Hessen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Braunschweig	Niedersachsen
Germany	GSK Investigational Site	Buchholz	Niedersachsen
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Cottbus	Brandenburg
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Erlangen	Bayern
Germany	GSK Investigational Site	Eschwege	Hessen
Germany	GSK Investigational Site	Geesthacht	Schleswig-Holstein
Germany	GSK Investigational Site	Greiz	Thueringen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Kaufbeuren	Bayern
Germany	GSK Investigational Site	Landsberg	Bayern
Germany	GSK Investigational Site	Marburg	Hessen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Rednitzhembach	Bayern
Germany	GSK Investigational Site	Sonneberg	Thueringen
Germany	GSK Investigational Site	Uttenreuth	Bayern
Germany	GSK Investigational Site	Wedel	Hamburg
Germany	GSK Investigational Site	Wuerzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Week 9 to Week 12
Secondary	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.	Baseline (Visit 3) and Week 12
Secondary	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.	Baseline (Viait 3) and Week 12
Secondary	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.	Week 12
Secondary	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.	Baseline (Visit 3) up to Week 12
Secondary	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).	Week 12
Secondary	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.	Baseline (Visit 3) up to Week 12
Secondary	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.	Baseline (Visit 3) and Week 12
Secondary	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.	Baseline (Visit 3) and Week 12
Secondary	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.	Baseline (Visit 3) and week 12
Secondary	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.	Baseline (Visit 3) and week 12
Secondary	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.	Up to week 12
Secondary	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.	Up to Week 12
Secondary	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.	Up to Week 12
Secondary	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.	Baseline (Visit 3) up to Week 12
Secondary	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.	Baseline (Visit 3) up to Week 12
Secondary	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.	Up to Week 12