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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02388373
• Other study ID #: OR00213
• Secondary ID: 2013-005365-39
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2014
• Last updated: June 20, 2016
• Start date: July 2014
• Est. completion date: March 2016

Study information

• Verified date: June 2016
• Source: Research in Real-Life Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone 250/formoterol 10

• Fluticasone 250/salmeterol 25

• Fluticasone 125/formoterol 5

Locations

Country	Name	City	State
United Kingdom	Research in Real Life Ltd	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Research in Real-Life Ltd	Napp Pharmaceuticals Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire score (ACQ7)	At week 12 in Phase 1 and Phase 2	12 weeks	No
Secondary	Lung function (FEV1 and FVC)	At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2	4 or 12 weeks	No
Secondary	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)	4 or 12 weeks	No
Secondary	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	4 or 12 weeks	No
Secondary	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	4 or 12 weeks	No
Secondary	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	4 or 12 weeks	No
Secondary	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	12 weeks	No
Secondary	Number of adverse events	Phase 1 and Phase 2	12 weeks	Yes
Secondary	Blood eosinophil count		Phase 2 baseline	No
Secondary	Asthma Control Questionnaire score (ACQ7) at week 4 in Phase 2		4 weeks (Phase 2 interim visit)	No