AsthmaPhase 4NCT02388373
A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down
A Phase 4 study testing Fluticasone 250/formoterol 10, Fluticasone 250/salmeterol 25 and Fluticasone 125/formoterol 5 in people with Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
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®. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone 250/formoterol 10, Fluticasone 250/salmeterol 25 and Fluticasone 125/formoterol 5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Asthma
- Being tested
- Fluticasone 250/formoterol 10, Fluticasone 250/salmeterol 25, Fluticasone 125/formoterol 5
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone 250/formoterol 10Drug
Also called Flutiform 250
Fluticasone 250/salmeterol 25Drug
Also called Seretide 250 Evohaler
Fluticasone 125/formoterol 5Drug
Also called Flutiform 125
| Study group | Role | What they receive |
|---|---|---|
| Seretide 250 | Active comparator | 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. Receives: Drug: Fluticasone 250/salmeterol 25 |
| Flutiform 250 | Active comparator | 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. Receives: Drug: Fluticasone 250/formoterol 10 |
| Flutiform 125 | Active comparator | 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. Receives: Drug: Fluticasone 125/formoterol 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire score (ACQ7)
At week 12 in Phase 1 and Phase 2
Measured: 12 weeks
Secondary outcomes (9)
Lung function (FEV1 and FVC)
At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks
Number of adverse events
Phase 1 and Phase 2
Measured: 12 weeks
Blood eosinophil count
Measured: Phase 2 baseline
Asthma Control Questionnaire score (ACQ7) at week 4 in Phase 2
Measured: 4 weeks (Phase 2 interim visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research in Real-Life Ltd
- Sponsor type
- Research network
- Collaborators
- Napp Pharmaceuticals Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388373
- Sponsor's protocol ID
- OR00213
- Other IDs
- 2013-005365-39
- Status last verified
- Jun 2016
- First submitted
- 15 Nov 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down
- ClinicalTrials.gov ID
- NCT02388373
- Acronym / sponsor ID
- OR00213
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Research in Real-Life LtdResearch network
- Collaborators
- Napp Pharmaceuticals Limited
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Seretide 250 | Active comparator | Drug: Fluticasone 250/salmeterol 25Seretide® 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. |
| Flutiform 250 | Active comparator | Drug: Fluticasone 250/formoterol 10flutiform® 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. |
| Flutiform 125 | Active comparator | Drug: Fluticasone 125/formoterol 5flutiform 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone 250/formoterol 10Also: Flutiform 250 | Drug | Flutiform 250 |
| Fluticasone 250/salmeterol 25Also: Seretide 250 Evohaler | Drug | Seretide 250 |
| Fluticasone 125/formoterol 5Also: Flutiform 125 | Drug | Flutiform 125 |
Primary outcome
Asthma Control Questionnaire score (ACQ7)
Time frame: 12 weeks
At week 12 in Phase 1 and Phase 2
9 secondary outcomes
Lung function (FEV1 and FVC)
Time frame: 4 or 12 weeks
Lung inflammation measured as level of Fractional Exhaled Nitric Oxide (FeNO)
Time frame: 4 or 12 weeks
Asthma control defined by Global Initiative of Asthma (GINA) guidelines at week 12 adjusting for baseline
Time frame: 4 or 12 weeks
Visual Analog Scale (VAS) Score at week 12 adjusting for baseline
Time frame: 4 or 12 weeks
Quality of life measured with Mini Asthma Quality of Life questionnaire at week 12 adjusting for baseline
Time frame: 4 or 12 weeks
Proportion of patients with asthma control
Time frame: 12 weeks
Number of adverse events
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Individual participant dataSharing planned: 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.
Related trials for Asthma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone 250/formoterol 10, Fluticasone 250/salmeterol 25 and Fluticasone 125/formoterol 5 in people with Asthma, run by Research in Real-Life Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire score (ACQ7) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.