A Phase 4 interventional study of Fluticasone 250/formoterol 10 and Fluticasone 250/salmeterol 25 in Asthma, sponsored by Research in Real-Life Ltd. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-21.
Sponsored by Research in Real-Life Ltd · Phase 4, Interventional, and Treatment
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.
Research in Real-Life Ltd is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
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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.
Exclusion Criteria:
Seretide® Evohaler® 25 microgram /50 microgram per metered dose pressurised inhalation, suspension. 25 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 220 micrograms of fluticasone propionate. 2 puffs twice daily for 12 weeks Phase 1.
Drug: Fluticasone 250/salmeterol 25
flutiform® 250 microgram/10 microgram per actuation pressurised inhalation, suspensions. 250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 230 microgram of fluticasone propionate/9.0 microgram of formoterol fumarate dihydrate. 2 puffs twice daily for 12 weeks in Phase 1 and 12 weeks in Phase 2.
Drug: Fluticasone 250/formoterol 10
flutiform 125 microgram/5 microgram per actuation pressurised inhalation, suspensions. 125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 microgram of fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate. 2 puffs twice daily for 12 weeks in Phase 2.
Drug: Fluticasone 125/formoterol 5
Also known as: Flutiform 250
Also known as: Seretide 250 Evohaler
Also known as: Flutiform 125
Asthma Control Questionnaire score (ACQ7)
At week 12 in Phase 1 and Phase 2
Time frame: 12 weeks
Lung function (FEV1 and FVC)
At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2
Time frame: 4 or 12 weeks
Lung inflammation measured as level of Fractional Exhaled Nitric Oxide (FeNO)
Phase 2 only (interim visit at week 4 and final visit at week 12)
Time frame: 4 or 12 weeks
Asthma control defined by Global Initiative of Asthma (GINA) guidelines at week 12 adjusting for baseline
At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2
Time frame: 4 or 12 weeks
Visual Analog Scale (VAS) Score at week 12 adjusting for baseline
At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2
Time frame: 4 or 12 weeks
Quality of life measured with Mini Asthma Quality of Life questionnaire at week 12 adjusting for baseline
At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2
Time frame: 4 or 12 weeks
Proportion of patients with asthma control
Phase 1 and Phase 2; Asthma control defined as No exacerbations, No change in therapy, and GINA asthma control achieved
Time frame: 12 weeks
Number of adverse events
Phase 1 and Phase 2
Time frame: 12 weeks
Blood eosinophil count
Time frame: Phase 2 baseline
Asthma Control Questionnaire score (ACQ7) at week 4 in Phase 2
Time frame: 4 weeks (Phase 2 interim visit)
Plan to share: No — Individual participant data will not be publically released as this was not covered by patient consent. Patients have consented for anonymised data to be used for future medical research by Research in Real-Life.
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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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