Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363480
First received: August 10, 2006
Last updated: March 17, 2011
Last verified: March 2011
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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
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, 81677 | |
| GSK Investigational Site | |
| Muenchen, Bayern, Germany, 80335 | |
| 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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013