Asthma MedDRA version: 16.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.1 Level: PT Classification code 10038683 Term: Respiratory disorder System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: flutiform® 125 microgram/5 microgram per actuation pressurised inhalation, suspension
Product Name: flutiform® 125 microgram/5 microgram per actuation pressurised inhalation, suspension
Ph
Sponsors
Research in Real-Life Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in phase 1 of the study, all of the criteria below need to be met: 1) Able and willing to provide written informed consent and to comply with the study protocol 2) Current diagnosis of asthma (as evidenced by appropriate diagnostic code) 3) Step 4 of the BTS guidelines 4) Received at least 4 inhalers of Seretide® 250 Evohaler® 2 puffs twice daily in the last 6 months (corresponds to =66% compliance) 5) No asthma exacerbation* in last 3 months 6) =2 exacerbations* in last 12 months 7) No critical errors in device use after training (during baseline visit) 8) 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 Only patients who received Flutiform and did not have any exacerbations in phase 1 will be eligible for phase 2 of the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 164 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1) Chronic respiratory disease other than asthma 2) Uncontrolled asthma (according to the Global Initiative for Asthma (GINA) criteria) 3) Participation in a clinical study within the past year 4) Hypersensitivity to Flutiform®, its component Formoterol or its excipients 5) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study has two phases. The primary objective of each phase is as follows: Phase 1: to test effectiveness of a recently licensed inhaler treatment, Flutiform®, against the effectiveness of a commonly used Seretide® Evohaler® inhaler in controlling asthma in real-life patients. Phase 2: to test if asthma control can be maintained with a reduced dosage of Flutiform® ;Secondary Objective: As secondary objectives we will compare other aspects of asthma between the two study groups in each phase. More specifically we will compare: 1) lung function 2) quality of life measured using a questionnaire 3) side-effects and bad responses 4) asthma control (using different measures of asthma control than for the primary objective) In addition in phase 2 we will compare levels of inflammation and evaluate if these could be used to predict how patients respond to reduction of treatment dosage. ;Primary end point(s): The primary outcome measure is asthma control measured using the ACQ7 score, which is calculated based on seven questions in the validated Asthma Control Questionnaire (ACQ). In phase 1 we will compare ACQ7 between the Flutiform and Seretide Evohaler groups and in phase 2 between medium and high dosage Flutiform groups.;Timepoint(s) of evaluation of this end point: We will measure the primary outcome at first visit of each phase (baseline) and at the end of each phase, i.e. at 12 weeks. In addition, ACQ7 is measured at an interim visit at week 4 of phase 2 to monitor safety of reducing dosage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): As secondary endpoints we will measure: 1) spirometry parameters 2) Mini-Asthma Quality of Life Questionnaire score 3) Visual Analog Scale Score 4) Asthma control level according to Global Initiative for Asthma (GINA) criteria 5) number of bad responses to treatment 6) In phase 2 we will measure the levels of fractional exhaled nitric oxide (FeNO) which is used to measure lung inflammation 7) As an additional measure of inflammation we will measure blood eosinophil counts at phase 2 baseline visit.;Timepoint(s) of evaluation of this end point: We will measure the secondary end points at first visit of each phase (baseline) and at the end of each phase, i.e. at 12 weeks. In addition, secondary end points 1-6 are measured at an interim visit at week 4 of phase 2 to monitor safety of reducing dosage and to evaluate whether levels of lung inflammation could be used as a predictor for how patients respond to reducing treatment. | — |
Countries
United Kingdom
Contacts
Public ContactAnu Kemppinen
Research in Real-Life Ltd
Outcome results
None listed