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

NCT00363480 | Completed Phase 4 Results

• 1 other identifier: SAM 106538
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 32

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.

Conditions

Asthma

Keywords

Asthma; Asthma Control Test; SERETIDE

Outcome Measures

Primary Outcomes (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

  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.

  Week 9 to Week 12

Secondary Outcomes (16)

• Change From Baseline in Percentage of Participants With ACT Score of 20-25 at Week 12

  Baseline (Visit 3) and Week 12

• Change From Baseline in Mean ACT Score at Visit 6

  Baseline (Viait 3) and Week 12

• Number of Participants With Well Controlled and Totally Controlled Asthma at Week 12

  Week 12

• Change From Baseline in Quality of Life Using the Asthma Quality of Life Questionnaire (AQLQ)

  Baseline (Visit 3) up to Week 12

• Correlation of Change in AQLQ Score and Change in ACT Score

  Week 12

Study Arms (1)

SFC 50/250 mcg

EXPERIMENTAL

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; Drug: Salbutamol 100 mcg; Device: DISKUS™ powder inhalers

Interventions

Salmeterol/Fluticasone 50/250 mcg DRUG

Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.

SFC 50/250 mcg

Salbutamol 100 mcg DRUG

This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol.

SFC 50/250 mcg

DISKUS™ powder inhalers DEVICE

Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.

SFC 50/250 mcg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (32)

GSK Investigational Site

Erlangen, Bavaria, 91052, Germany

Location

GSK Investigational Site

Kaufbeuren, Bavaria, 87600, Germany

Location

GSK Investigational Site

Landsberg am Lech, Bavaria, 86899, Germany

Location

GSK Investigational Site

Munich, Bavaria, 80335, Germany

Location

GSK Investigational Site

Munich, Bavaria, 81677, Germany

Location

GSK Investigational Site

Rednitzhembach, Bavaria, 91126, Germany

Location

GSK Investigational Site

Uttenreuth, Bavaria, 91080, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Cottbus, Brandenburg, 03050, Germany

Location

GSK Investigational Site

Wedel, Hamburg, 22880, Germany

Location

GSK Investigational Site

Bad Arolsen, Hesse, 34454, Germany

Location

GSK Investigational Site

Eschwege, Hesse, 37269, Germany

Location

GSK Investigational Site

Kassel, Hesse, 34117, Germany

Location

GSK Investigational Site

Kassel, Hesse, 34121, Germany

Location

GSK Investigational Site

Marburg, Hesse, 35037, Germany

Location

GSK Investigational Site

Braunschweig, Lower Saxony, 38100, Germany

Location

GSK Investigational Site

Buchholz, Lower Saxony, 21244, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30159, Germany

Location

GSK Investigational Site

Hanover, Lower Saxony, 30167, Germany

Location

GSK Investigational Site

Chemnitz, Saxony, 09126, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01099, Germany

Location

GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

Location

GSK Investigational Site

Greiz, Thuringia, 07973, Germany

Location

GSK Investigational Site

Sonneberg, Thuringia, 96515, Germany

Location

GSK Investigational Site

Berlin, 10367, Germany

Location

GSK Investigational Site

Berlin, 10717, Germany

Location

GSK Investigational Site

Berlin, 10965, Germany

Location

GSK Investigational Site

Berlin, 12165, Germany

Location

GSK Investigational Site

Berlin, 12687, Germany

Location

GSK Investigational Site

Berlin, 13187, Germany

Location

GSK Investigational Site

Berlin, 13597, Germany

Location

GSK Investigational Site

Hamburg, 22767, Germany

Location

MeSH Terms

Conditions

Asthma

Interventions

Salmeterol Xinafoate; Fluticasone; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: May 17, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 14, 2007
• Last Updated: March 9, 2018
• Results First Posted: March 9, 2018

Record last verified: 2018-03

Locations

DE (32)