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AsthmaPhase 4NCT00351143

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

A Phase 4 study testing salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training and salmeterol/fluticasone propionate 50/250 µg in people with Asthma, run by GlaxoSmithKline at 32 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training and salmeterol/fluticasone propionate 50/250 µg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
32 sitesin 2 countries
Study dates
26 Jul 2005to 13 Jun 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

32 sites in 2 countries.

32 sites in 2 countries

Switzerland26 sites

  • GSK Investigational Site

    Aarau, 5000

  • GSK Investigational Site

    Allschwil, 4123

  • GSK Investigational Site

    Basel, 4001

  • GSK Investigational Site

    Basel, 4031

  • GSK Investigational Site

    Basel, 4053

  • GSK Investigational Site

    Basel, 4054

  • GSK Investigational Site

    Basel, 4058

  • GSK Investigational Site

    Bern, 3007

  • GSK Investigational Site

    Bern, 3011

  • GSK Investigational Site

    Bern, 3012

  • GSK Investigational Site

    Bever, 7502

  • GSK Investigational Site

    Brittnau, 4805

  • GSK Investigational Site

    Castione, 6532

  • GSK Investigational Site

    Düdingen, 3186

  • GSK Investigational Site

    Egg, 8132

  • GSK Investigational Site

    Faltigberg-Wald, 8639

  • GSK Investigational Site

    Horw, 6048

  • GSK Investigational Site

    Klosters Platz, 7250

  • GSK Investigational Site

    Malvaglia, 6713

  • GSK Investigational Site

    Massagno, 6900

  • GSK Investigational Site

    Pregassona, 6963

  • GSK Investigational Site

    Steckborn, 8266

  • GSK Investigational Site

    Thun, 3600

  • GSK Investigational Site

    Wald, 8636

  • GSK Investigational Site

    Wigoltingen, 8556

  • GSK Investigational Site

    Worb, 3076

Other trials in Switzerland

Denmark6 sites

  • GSK Investigational Site

    Aalborg, DK-9100

  • GSK Investigational Site

    Aarhus C, DK-8000

  • GSK Investigational Site

    Hvidovre, 2650

  • GSK Investigational Site

    København NV, 2400

  • GSK Investigational Site

    Næstved, 4700

  • GSK Investigational Site

    Odense C, 5000

Other trials in Denmark

About this study

Official title: A Randomized, Open Label Comparative Study to Determine the Proportion of Asthma Patients on SERETIDE Diskus 50/250 mcg b.i.d. Achieving Total Control When Given Medication and Compliance Enhancement Training Compared to Those Receiving Medication Only

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
Being tested
salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training, salmeterol/fluticasone propionate 50/250 µg
Keywords
QoL, Asthma, asthma compliance enhancement, Salmeterol/fluticasone, Total control, SERETIDE, FEV1
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • salmeterol/fluticasone propionate 50/250 µgDrug

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

Study groups in NCT00351143
Study groupRoleWhat they receive
Interventional group: Period 2ExperimentalRandomized subjects will receive salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training in Period 2
Receives: Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
Control group: Period 2Active comparatorRandomized subjects will receive salmeterol/fluticasone propionate 50/250 µg in treatment Period 2
Receives: Drug: salmeterol/fluticasone propionate 50/250 µg
Subjects receiving salmeterol/fluticasone propionate: Period 1ExperimentalAll subjects treated with salmeterol/fluticasone propionate 50/250 µg b.i.d without any other intervention will be included in Period 1
Receives: Drug: salmeterol/fluticasone propionate 50/250 µg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to Week 24

Secondary outcomes (10)

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

    Proportion of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing in treatment period 1 will be analyzed.

    Measured: Up to Week 12

  2. Time to first individual week with Total Control

    Time to first individual week with Total Control in treatment period 2 will be analyzed.

    Measured: Up to Week 24

  3. Morning peak expiratory flow (PEF)

    PEF is defined as a person's maximum speed of expiration and will be measured using a peak flow meter.

    Measured: Up to Week 24

  4. Forced expiratory volume in one second (FEV1)

    FEV1 is defined as Forced Expiratory Volume in the first second. The volume of air that can be forced out in one second after taking a deep breath, an important measure of pulmonary function.

    Measured: Up to Week 24

  5. Asthma symptom score

    Asthma symptom score will be analyzed to check the symptom severity

    Measured: Up to Week 24

  6. Number of subjects using rescue medication

    Rescue medication usage will be analyzed.

    Measured: Up to Week 24

  7. Number of nights with awakening due to asthma

    Number of nights with awakening due to asthma will be analyzed.

    Measured: Up to Week 24

  8. Asthma severity score

    Asthma severity score will be analyzed

    Measured: Up to Week 24

  9. Number of subjects with adverse events (AEs)

    Adverse events will be observed and counted.

    Measured: Up to Week 24

  10. AQLQ score

    Quality of life of subjects with asthma will be analyzed.

    Measured: Up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2006 (estimated)
  2. Study start26 Jul 2005
  3. Primary completion13 Jun 2007
  4. Study completion13 Jun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00351143
Sponsor's protocol ID
ACE104325
Status last verified
Sep 2017
First submitted
11 Jul 2006
Last updated
11 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20298399

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training and salmeterol/fluticasone propionate 50/250 µg in people with Asthma, run by GlaxoSmithKline at 32 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Switzerland, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of subjects who achieved Total asthma Control: Period 2 (time frame: Up to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00351143, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.

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