We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00363480
First Posted: August 15, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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 Intervention Phase
Asthma Drug: Salmeterol/Fluticasone 50/250 µg Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of well controlled participants as per gaining optimal asthma control (GOAL) criteria after 12 week compared to number 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. A score of 19 or less may be a sign that asthma symptoms are not under control.


Secondary Outcome Measures:
  • 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. 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.

  • 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. 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.

  • 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. 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.

  • 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).

  • 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).

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 220
Study Start Date: May 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Salmeterol/Fluticasone 50/250 µg
    salmeterol/fluticasone combination 50/250 µg twice daily
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00363480


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     History of Changes
Other Study ID Numbers: SAM 106538
First Submitted: August 10, 2006
First Posted: August 15, 2006
Last Update Posted: October 12, 2017
Last Verified: January 2017

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
Salmeterol Xinafoate
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists