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

• ClinicalTrials.gov Identifier: NCT00363480
• Recruitment Status: Completed
• First Posted: August 15, 2006
• Results First Posted: March 9, 2018
• Last Update Posted: March 9, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Salmeterol/Fluticasone 50/250 mcg; Drug: Salbutamol 100 mcg; Device: DISKUS™ powder inhalers	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 221 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Asthma Control Assessment Via ACT and DRC in Asthmatics Treated With Seretide (50/250) Over 12 Weeks
• Actual Study Start Date: May 17, 2006
• Actual Primary Completion Date: September 1, 2007
• Actual Study Completion Date: September 14, 2007

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Drug: Salmeterol/Fluticasone 50/250 mcg; Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.; Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 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.

Secondary Outcome Measures :

1. Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12 [ Time Frame: Baseline (Visit 3) and 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.
2. Change From Baseline in Mean ACT Score at Visit 6 [ Time Frame: Baseline (Viait 3) and 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 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.
3. Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12 [ Time Frame: 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.
4. Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Baseline (Visit 3) up to Week 12 ]
   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.
5. Correlation of Change in AQLQ Score and Change in ACT Score [ Time Frame: Week 12 ]
   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).
6. Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12 [ Time Frame: Baseline (Visit 3) up 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.
7. Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12 [ Time Frame: Baseline (Visit 3) and 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.
8. Change From Baseline in Mean 24-hour Symptom Score at Week 12 [ Time Frame: Baseline (Visit 3) and 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.
9. Change From Baseline in Number of Additional Usage of Salbutamol at Week 12 [ Time Frame: Baseline (Visit 3) and 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.
10. Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12 [ Time Frame: Baseline (Visit 3) and 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.
11. Number of Participants With Emergency Visits Due to Asthma [ Time Frame: Up to week 12 ]
    Frequencies of emergency visits per participant were recorded during treatment period. Only the participants at risk were considered when calculating the incidence rates.
12. Number of Participants With Adverse Events (AE) Leading to a Change in Asthma Treatment [ Time Frame: Up to Week 12 ]
    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.
13. Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE [ Time Frame: Up to Week 12 ]
    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.
14. Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [ Time Frame: Baseline (Visit 3) up to Week 12 ]
    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.
15. Assessment of Tolerability by Change From Baseline of Pulse Rate [ Time Frame: Baseline (Visit 3) up to Week 12 ]
    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.
16. Number of Participants With Occurrence of (Near-) Incidents Associated With Peak Flow Measurements [ Time Frame: Up to Week 12 ]
    Frequencies of participants with at least one (near-) incident associated with peak flow measurements were recorded. analysis was done on safety population.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

GSK Investigational Site

Erlangen, Bayern, Germany, 91052

GSK Investigational Site

Kaufbeuren, Bayern, Germany, 87600

GSK Investigational Site

Landsberg, Bayern, Germany, 86899

GSK Investigational Site

Muenchen, Bayern, Germany, 80335

GSK Investigational Site

Muenchen, Bayern, Germany, 81677

GSK Investigational Site

Rednitzhembach, Bayern, Germany, 91126

GSK Investigational Site

Uttenreuth, Bayern, Germany, 91080

GSK Investigational Site

Wuerzburg, Bayern, Germany, 97070

GSK Investigational Site

Cottbus, Brandenburg, Germany, 03050

GSK Investigational Site

Wedel, Hamburg, Germany, 22880

GSK Investigational Site

Bad Arolsen, Hessen, Germany, 34454

GSK Investigational Site

Eschwege, Hessen, Germany, 37269

GSK Investigational Site

Kassel, Hessen, Germany, 34117

GSK Investigational Site

Kassel, Hessen, Germany, 34121

GSK Investigational Site

Marburg, Hessen, Germany, 35037

GSK Investigational Site

Braunschweig, Niedersachsen, Germany, 38100

GSK Investigational Site

Buchholz, Niedersachsen, Germany, 21244

GSK Investigational Site

Hannover, Niedersachsen, Germany, 30159

GSK Investigational Site

Hannover, Niedersachsen, Germany, 30167

GSK Investigational Site

Chemnitz, Sachsen, Germany, 09126

GSK Investigational Site

Dresden, Sachsen, Germany, 01099

GSK Investigational Site

Geesthacht, Schleswig-Holstein, Germany, 21502

GSK Investigational Site

Greiz, Thueringen, Germany, 07973

GSK Investigational Site

Sonneberg, Thueringen, Germany, 96515

GSK Investigational Site

Berlin, Germany, 10367

GSK Investigational Site

Berlin, Germany, 10717

GSK Investigational Site

Berlin, Germany, 10965

GSK Investigational Site

Berlin, Germany, 12165

GSK Investigational Site

Berlin, Germany, 12687

GSK Investigational Site

Berlin, Germany, 13187

GSK Investigational Site

Berlin, Germany, 13597

GSK Investigational Site

Hamburg, Germany, 22767

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00363480
• Other Study ID Numbers: SAM 106538
• First Posted: August 15, 2006
• Results First Posted: March 9, 2018
• Last Update Posted: March 9, 2018
• Last Verified: March 2018

Keywords provided by GlaxoSmithKline:

Asthma; Asthma Control Test; SERETIDE

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Albuterol; Salmeterol Xinafoate; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Tocolytic Agents; Reproductive Control Agents