Clinical trial NCT00363480: Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data
Official title: Asthma Control Assessment Via ACT and DRC in Asthmatics Treated With Seretide (50/250) Over 12 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Asthma Control Test
SERETIDE
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-15
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Week 9 to Week 12
Secondary outcomes:
measure: Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12
timeFrame: Baseline (Visit 3) and Week 12
measure: Change From Baseline in Mean ACT Score at Visit 6
timeFrame: Baseline (Viait 3) and Week 12
measure: Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12
timeFrame: Week 12
measure: Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Baseline (Visit 3) up to Week 12
measure: Correlation of Change in AQLQ Score and Change in ACT Score
timeFrame: Week 12
measure: Change From Baseline in Forced Expiratory Volume (FEV1) to Week 12
timeFrame: Baseline (Visit 3) up to Week 12
measure: Change From Baseline in Mean Morning Percent Predicted Peak Expiratory Flow (PEF) at Week 12
timeFrame: Baseline (Visit 3) and Week 12
measure: Change From Baseline in Mean 24-hour Symptom Score at Week 12
timeFrame: Baseline (Visit 3) and Week 12
measure: Change From Baseline in Number of Additional Usage of Salbutamol at Week 12
timeFrame: Baseline (Visit 3) and week 12
measure: Percent Change From Baseline in Number of Nights With no Nocturnal Awakening at Week 12
timeFrame: Baseline (Visit 3) and week 12
measure: Number of Participants With Emergency Visits Due to Asthma
timeFrame: Up to week 12
measure: Number of Participants With Adverse Events (AE) Leading to a Change in Asthma Treatment
timeFrame: Up to Week 12
measure: Assessment of Tolerability by Number of Participants With at Least One Treatment Emergent Serious and, Non-serious AE
timeFrame: Up to Week 12
measure: Assessment of Tolerability by Change From Baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
timeFrame: Baseline (Visit 3) up to Week 12
measure: Assessment of Tolerability by Change From Baseline of Pulse Rate
timeFrame: Baseline (Visit 3) up to Week 12
measure: Number of Participants With Occurrence of (Near-) Incidents Associated With Peak Flow Measurements
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kaufbeuren
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Landsberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Rednitzhembach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Uttenreuth
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Cottbus
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Wedel
country: Germany
facility: GSK Investigational Site
state: Hamburg
city: Bad Arolsen
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Eschwege
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Kassel
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Marburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Braunschweig
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Buchholz
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Chemnitz
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Greiz
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Sonneberg
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: