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NCT Number: NCT02388373

A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down

The aim of this study is to compare two licensed asthma inhalers and to then evaluate the safety of reducing treatment when patient's asthma is in control. The inhalers used in this study are the Seretide® 250 Evohaler®, which is widely used in UK, and a recently licensed inhaler called Flutiform®. National guidelines recommend that asthma medication should be increased when patients are experiencing worsening of their asthma, and reduced when asthma is in control. However, it is likely that in daily clinical practice some patients are over-treated. It is therefore necessary to conduct more studies which demonstrate that reducing treatment dosage can be done safely.

This study has two phases. In the first phase the investigators aim to recruit 224 patients through approximately 40 clinics in the UK and Ireland. One third of these patients will be selected in random to use the high dosage Seretide® 250 Evohaler® and two thirds will use high dose Flutiform® 250 inhaler for 12 weeks. At the end of phase 1 the investigators will compare how well asthma was controlled between the two groups.

After phase 1 those patients who used Flutiform and did not have any problems with their asthma can participate in phase 2. In phase 2 half of the patients will stay on high dosage Flutiform 250 and half will be switched to the medium dosage Flutiform 125 inhaler. At the end of phase 2 the investigators will compare asthma control between the two groups.

This study will be conducted by Research in Real Life Ltd (Cambridge, UK) with partial funding from Napp Pharmaceuticals Ltd. The estimated total duration of the study is 18 months and each patient will spend a maximum of 6 months in the study.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research in Real Life Ltd

Cambridge, CB24 3BA, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to provide written informed consent and to comply with the study protocol.
  • Current diagnosis of asthma (as evidenced by appropriate diagnostic code)
  • Received Seretide® 250 Evohaler® 2 puffs twice daily for the last 6 months
  • No asthma exacerbation* in last 3 months
  • ≤2 exacerbations* in last 12 months
  • No errors in device use after training (during baseline visit)
  • Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD) known to have a failure rate of less than 1% per year, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
  • Exacerbation defined as acute course of oral steroids, emergency room attendance and/or hospitalisation for asthma

Exclusion criteria

  • Other chronic respiratory disease than asthma (e.g. Chronic Obstructive Pulmonary Disease (COPD))
  • Uncontrolled asthma (GINA criteria)
  • The patient has used a clinical trial investigational drug within the last year before the screening visit
  • Hypersensitivity to Flutiform®, its component Formoterol or its excipients
  • Pregnant subjects

Treatment and study plan

Fluticasone 250/formoterol 10

Drug

Other names: Flutiform 250

Fluticasone 250/salmeterol 25

Drug

Other names: Seretide 250 Evohaler

Fluticasone 125/formoterol 5

Drug

Other names: Flutiform 125

Primary outcomes

  1. Asthma Control Questionnaire score (ACQ7)

    Time frame: 12 weeks

    At week 12 in Phase 1 and Phase 2

Secondary outcomes

  1. Lung function (FEV1 and FVC)

    Time frame: 4 or 12 weeks

    At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2

  2. Lung inflammation measured as level of Fractional Exhaled Nitric Oxide (FeNO)

    Time frame: 4 or 12 weeks

    Phase 2 only (interim visit at week 4 and final visit at week 12)

  3. Asthma control defined by Global Initiative of Asthma (GINA) guidelines at week 12 adjusting for baseline

    Time frame: 4 or 12 weeks

    At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2

  4. Visual Analog Scale (VAS) Score at week 12 adjusting for baseline

    Time frame: 4 or 12 weeks

    At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2

  5. Quality of life measured with Mini Asthma Quality of Life questionnaire at week 12 adjusting for baseline

    Time frame: 4 or 12 weeks

    At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2

  6. Proportion of patients with asthma control

    Time frame: 12 weeks

    Phase 1 and Phase 2; Asthma control defined as No exacerbations, No change in therapy, and GINA asthma control achieved

  7. Number of adverse events

    Time frame: 12 weeks

    Phase 1 and Phase 2

  8. Blood eosinophil count

    Time frame: Phase 2 baseline

  9. Asthma Control Questionnaire score (ACQ7) at week 4 in Phase 2

    Time frame: 4 weeks (Phase 2 interim visit)

Sponsors and collaborators

Lead sponsor

Research in Real-Life Ltd

Network

Collaborators

  • Napp Pharmaceuticals Limited

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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