Clinical trial NCT02388373: A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down
Official title: A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Research in Real-Life Ltd
Sponsor class: NETWORK
Collaborators: name: Napp Pharmaceuticals Limited
First posted: 2015-03-17
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control Questionnaire score (ACQ7)
timeFrame: 12 weeks
Secondary outcomes:
measure: Lung function (FEV1 and FVC)
timeFrame: 4 or 12 weeks
measure: Lung inflammation measured as level of Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: 4 or 12 weeks
measure: Asthma control defined by Global Initiative of Asthma (GINA) guidelines at week 12 adjusting for baseline
timeFrame: 4 or 12 weeks
measure: Visual Analog Scale (VAS) Score at week 12 adjusting for baseline
timeFrame: 4 or 12 weeks
measure: Quality of life measured with Mini Asthma Quality of Life questionnaire at week 12 adjusting for baseline
timeFrame: 4 or 12 weeks
measure: Proportion of patients with asthma control
timeFrame: 12 weeks
measure: Number of adverse events
timeFrame: 12 weeks
measure: Blood eosinophil count
timeFrame: Phase 2 baseline
measure: Asthma Control Questionnaire score (ACQ7) at week 4 in Phase 2
timeFrame: 4 weeks (Phase 2 interim visit)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Research in Real Life Ltd
Study officials:
References: