A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control

NCT00351143 | Completed Phase 4

• 1 other identifier: ACE104325
• Study Type: interventional
• Target: 274
• Locations: 2 countries
• Sites: 32

Brief Summary

This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.

Conditions

Asthma

Keywords

QoL; Asthma; asthma compliance enhancement; Salmeterol/fluticasone; Total control; SERETIDE; FEV1

Outcome Measures

Primary Outcomes (1)

• number of subjects who achieved Total asthma Control: Period 2

  Proportion of subjects who achieved Total Control in 7 out of the last 8 consecutive weeks in treatment period 2 with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing and compliance enhancement training compared with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing without compliance enhancement training.

  Up to Week 24

Secondary Outcomes (10)

• Number of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing: Period 2

  Up to Week 12

• Time to first individual week with Total Control

  Up to Week 24

• Morning peak expiratory flow (PEF)

  Up to Week 24

• Forced expiratory volume in one second (FEV1)

  Up to Week 24

• Asthma symptom score

  Up to Week 24

Study Arms (3)

Interventional group: Period 2

EXPERIMENTAL

Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2

Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training

Control group: Period 2

ACTIVE COMPARATOR

Randomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2

Drug: salmeterol/fluticasone propionate 50/250 µg

Subjects receiving salmeterol/fluticasone propionate: Period 1

EXPERIMENTAL

All subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1

Drug: salmeterol/fluticasone propionate 50/250 µg

Interventions

salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training DRUG

Salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training will be provided to intervention group in Period 2.

Interventional group: Period 2

salmeterol/fluticasone propionate 50/250 µg DRUG

Salmeterol/fluticasone propionate 50/250 µg will be administered to control group in Period 2

Control group: Period 2; Subjects receiving salmeterol/fluticasone propionate: Period 1

Eligibility Criteria

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

You may qualify if:

• Diagnosed with persistent asthma.
• Not treated with the combination of a ICS (inhaled corticosteroid)and a LABA (long-acting beta-agonist).
• Female subjects must not be fertile or must use effective contraception.
• Subject must be able to comply with the use of the questionnaires in the local language.

You may not qualify if:

• Known or suspected Chronic Obstructive Pulmonary Disease.
• Pregnant or lactating.
• Participating investigator, employee of an investigator, or family member of any of the aforementioned.
• Smoking history: Pack-years \> 10 years.
• Have known clinical or laboratory evidence of a serious uncontrolled systemic disease.
• Known hypersensitivity to any substance contained in investigational product or as-needed medication.
• Treatment with oral corticosteroid within 2 months prior to the screening visit.
• Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit.
• Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (32)

GSK Investigational Site

Aalborg, DK-9100, Denmark

Location

GSK Investigational Site

Aarhus C, DK-8000, Denmark

Location

GSK Investigational Site

Hvidovre, 2650, Denmark

Location

GSK Investigational Site

København NV, 2400, Denmark

Location

GSK Investigational Site

Næstved, 4700, Denmark

Location

GSK Investigational Site

Odense C, 5000, Denmark

Location

GSK Investigational Site

Aarau, 5000, Switzerland

Location

GSK Investigational Site

Allschwil, 4123, Switzerland

Location

GSK Investigational Site

Basel, 4001, Switzerland

Location

GSK Investigational Site

Basel, 4031, Switzerland

Location

GSK Investigational Site

Basel, 4053, Switzerland

Location

GSK Investigational Site

Basel, 4054, Switzerland

Location

GSK Investigational Site

Basel, 4058, Switzerland

Location

GSK Investigational Site

Bern, 3007, Switzerland

Location

GSK Investigational Site

Bern, 3011, Switzerland

Location

GSK Investigational Site

Bern, 3012, Switzerland

Location

GSK Investigational Site

Bever, 7502, Switzerland

Location

GSK Investigational Site

Brittnau, 4805, Switzerland

Location

GSK Investigational Site

Castione, 6532, Switzerland

Location

GSK Investigational Site

Düdingen, 3186, Switzerland

Location

GSK Investigational Site

Egg, 8132, Switzerland

Location

GSK Investigational Site

Faltigberg-Wald, 8639, Switzerland

Location

GSK Investigational Site

Horw, 6048, Switzerland

Location

GSK Investigational Site

Klosters Platz, 7250, Switzerland

Location

GSK Investigational Site

Malvaglia, 6713, Switzerland

Location

GSK Investigational Site

Massagno, 6900, Switzerland

Location

GSK Investigational Site

Pregassona, 6963, Switzerland

Location

GSK Investigational Site

Steckborn, 8266, Switzerland

Location

GSK Investigational Site

Thun, 3600, Switzerland

Location

GSK Investigational Site

Wald, 8636, Switzerland

Location

GSK Investigational Site

Wigoltingen, 8556, Switzerland

Location

GSK Investigational Site

Worb, 3076, Switzerland

Location

Related Publications (1)

• Ulrik CS, Claudius BK, Tamm M, Harving H, Siersted HC, Backer V, Hellquist B, Dahl R, Hogholm A, Johnk IK. Effect of asthma compliance enhancement training on asthma control in patients on combination therapy with salmeterol/fluticasone propionate: a randomised controlled trial. Clin Respir J. 2009 Jul;3(3):161-8. doi: 10.1111/j.1752-699X.2009.00129.x.

  PMID: 20298399 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Salmeterol Xinafoate; Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: July 26, 2005
• Primary Completion: June 13, 2007
• Study Completion: June 13, 2007
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

CH (26); DK (6)