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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363480
First received: August 10, 2006
Last updated: March 17, 2011
Last verified: March 2011
  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 Salmeterol/Fluticasone combination (SFC) 50/250 µg bd. 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: Fluticasone propionate/salmeterol(50/250µg)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reaching Asthma Control With Salmeterol/Fluticasone 50/250 µg bd Combination in Steroid Naive or Low Dose Inhaled Corticoid Steroid Patients by Using Asthma Control Test (ACT) Comparison of Patient Self Rating With Diary Card Data.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of well controlled patients according to GOAL criteria after 12 week treatment with SFC 50/250 µg bd compared to number of patients achieving an ACT score of 20-25 for the last 4 weeks of treatment period.

Secondary Outcome Measures:
  • Change of number of patients achieving an ACT score 20-25 after end of treatment compared to Visit 3
  • Change in Forced Expiratory Volume (FEV1)
  • Change in morning Peak Expiratory Volume (PEF)

Estimated Enrollment: 250
Study Start Date: May 2006
Intervention Details:
    Drug: Fluticasone propionate/salmeterol(50/250µg)
    Other Name: Fluticasone propionate/salmeterol(50/250µg)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Cottbus, Brandenburg, Germany, 03050
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
GSK Investigational Site
Kassel, Hessen, Germany, 34121
GSK Investigational Site
Kassel, Hessen, Germany, 34117
GSK Investigational Site
Marburg, Hessen, Germany, 35037
GSK Investigational Site
Braunschweig, Niedersachsen, Germany, 38100
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, 13597
GSK Investigational Site
Berlin, Germany, 12165
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Berlin, Germany, 12687
GSK Investigational Site
Berlin, Germany, 10965
GSK Investigational Site
Berlin, Germany, 10717
GSK Investigational Site
Berlin, Germany, 13187
GSK Investigational Site
Hamburg, Germany, 22767
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00363480     History of Changes
Other Study ID Numbers: SAM 106538
Study First Received: August 10, 2006
Last Updated: March 17, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
Asthma
Asthma Control Test
SERETIDE

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014