AsthmaPhase 4NCT02416180

Study to Evaluate Handling Errors in Usage of SERETIDE® Metered Dose Inhaler (MDI) (EVOHALER®) by Adult Subjects Currently Using the SERETIDE DISKUS® Inhaler

A Phase 4 study testing SERETIDE MDI in people with Asthma, run by GlaxoSmithKline at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to explore the potential impact of switching inhalers by assessing the handling error rate (critical and non-critical) in controlled asthmatics currently treated with, and using correctly, SERETIDE via the DISKUS Inhaler who are switched to receiving SERETIDE via the Metered Dose Inhaler (MDI)… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: SERETIDE MDI
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 111 participants
Where: 7 sitesGermany
Study dates: 18 Jun 2015to 20 Aug 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

>=18 years of age at the time of informed consent.
A diagnosis of asthma as defined by the National Institutes of Health, 2007.
Must be currently treated with SERETIDE via the DISKUS Inhaler and have been maintained on this dose for 3 months prior to Visit 1.
Have controlled asthma defined as a total ACT score >= 20
Must be able to use their DISKUS inhaler correctly. Correct use is defined as making no critical errors during the assessment of DISKUS inhaler use at Visit 1.
Male

Show all 9Show fewer

Female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: 1. Non-reproductive potential defined as: Pre-menopausal females with one of the following; documented tubal ligation, documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, hysterectomy, documented bilateral Oophorectomy. Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. 2. Reproductive potential and agrees to follow one of the options listed below in the GSK modified list of highly effective methods for avoiding pregnancy in females of reproductive potential (FRP) requirements from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up contact.
GSK modified list of highly effective methods for avoiding pregnancy in FRP: a. Contraceptive subdermal implant that meets the standard operating procedure (SOP) effectiveness criteria including a <1percent rate of failure per year, as stated in the product label. b. Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1 percent rate of failure per year, as stated in the product label. c. Oral Contraceptive, either combined or progestogen alone. d. Injectable progestogen. e. Contraceptive vaginal ring. f. Percutaneous contraceptive patches. g. Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject. h. Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository). GSK modified list of highly effective methods for avoiding pregnancy in FRP does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis. These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol.

Who cannot join

Have a current diagnosis of chronic obstructive pulmonary disease (COPD)
Have experienced an asthma exacerbation within 3 months of Visit 1 or a lower respiratory tract infection within 6 weeks of Visit 1. An exacerbation is defined as worsening asthma requiring any treatment other than rescue salbutamol. This includes requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalisation.
Other Concurrent Diseases: A subject must not have any clinically significant, uncontrolled condition or disease state (such as severe cardiovascular disorders or heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or predisposition to low levels of serum potassium) that, in the opinion of the investigator (in consultation with the GSK Medical Monitor if required), would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study. Please refer to the SERETIDE Product Label for a full list of conditions for special warnings and precautions for use.
Currently taking potent Cytochrome P450 3A4 (CYP 3A4) inhibitors
Currently taking beta-blockers (selective and non-selective).
Allergic to salmeterol, fluticasone propionate or to norflurane (HFA 134a) or to any other excipients.
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Germany7 sites

GSK Investigational Site
Berlin, 10717
GSK Investigational Site
Berlin, 10787
GSK Investigational Site
Berlin, 13086
GSK Investigational Site
Frankfurt am Main, Hesse, 60389
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Neu-Isenburg, Hesse, 63263
GSK Investigational Site
Reinfeld, Schleswig-Holstein, 23858

Other trials in Germany

About this study

Official title: An Open-label Study Investigating Critical and Overall Errors Following 14 Days of Treatment With SERETIDE Metered Dose Inhaler (EVOHALER) in Adult Subjects With Controlled Asthma Currently Using the SERETIDE DISKUS Inhaler

This will be a descriptive, multi-centre, open-label, non randomized 14 day study assessing MDI technique in subjects with controlled asthma (Asthma Control Test [ACT] score >= 20 at Visit 1) currently treated with, and able to use correctly, SERETIDE via the DISKUS Inhaler. All the eligible subjects will be switched to an equivalent dose of SERETIDE via the MDI. Subjects will need to use the MDI inhaler in accordance the accompanying patient information leaflet (to be read prior to use) for approximately 14 days. No instruction, coaching or comment on inhaler technique will be provided by the HCP. MDI technique of subjects will be assessed at Visit 2 (after 14 days) and the errors will be recorded. Subject will revert back to using their SERETIDE DISKUS inhaler again from Visit 2. Subjects will be followed up by telephone for approximately 1 week after Visit 2.

A maximum of 110 subjects will be enrolled such that approximately 100 evaluable subjects complete the study. The total duration of the study for each subject will be approximately 21 days.

SERETIDE, EVOHALER and DISKUS are registered trademarks of the GlaxoSmithKline (GSK) group of companies

Conditions: Asthma
Being tested: SERETIDE MDI, Placebo DISKUS Inhaler, Placebo MDI
Keywords: EVOHALER, Asthma, SERETIDE, DISKUS Inhaler, MDI
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SERETIDE MDIDevice
Commercially available SERETIDE MDI (EVOHALER) containing fluticasone propionate/salmeterol. Subjects will use MDI as 2 inhalations twice daily at the dose equivalent to their usual maintenance treatment of SERETIDE via DISKUS Inhaler.
Placebo DISKUS InhalerDevice
Placebo dry powder inhaler to be used to demonstrate the use of DISKUS inhaler at Visit 1
Placebo MDIDevice
Clear liquid propellant inhaler to be used to demonstrate the use of MDI at Visit 2

Study groups in NCT02416180
Study group	Role	What they receive
SERETIDE EVOHALER	Experimental	Subjects will switch from their current usual maintenance treatment of SERETIDE via DISKUS Inhaler to an equivalent dose of SERETIDE via the MDI (EVOHALER) at Visit 1. Subjects will use the MDI as 2 inhalations twice daily for approximately 14 days. Subjects will revert back to using SERETIDE DISKUS Inhaler again from Visit 2 (after 14 days) starting with the next scheduled dose. Receives: Device: SERETIDE MDI; Device: Placebo DISKUS Inhaler; Device: Placebo MDI

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14
Participant's inhaler use was assessed on Day 14 by the health care professional (HCP) against a predefined list of critical errors (CEs). Critical errors were defined as errors that were most likely to result in no or only minimal medication being inhaled. The participants were asked to demonstrate their usage of the MDI using a placebo demonstration MDI by HCP, critical or non-critical errors (N-CEs) and even no errors made by the participants while using the MDI were recorded. Critical errors in using the MDI were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. 95% confidence interval (CI) is for the % of participants making at least one critical error after the first assessment of the MDI technique, and was calculated using the exact binomial distribution.
Measured: Day 14

Secondary outcomes (3)

Percentage of Participants Making at Least One Overall Error After the First Assessment of MDI Technique on Day 14.
Inhaler use was assessed on Day 14 for overall errors. Overall errors included CEs or N-CEs. Demonstration of usage was with MDI and placebo, CE or N-CEs and even no errors were recorded. CEs were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. N-CEs were defined as: failure to inhale within 5 seconds of shaking the device; no exhalation before an inhalation; the inhalation manoeuvre was not slow and/or was not deep; dose coordination was sub-optimal but patient likely to have received some dose; more than one actuation during an inhalation manoeuvre; did not hold breath. The exact 95% confidence interval is for percent of participants making at least one CE after the first assessment of the MDI technique, and was calculated using exact binomial distribution.
Measured: Day 14
Number of Health Care Professional (HCP) Instructions Required on Day 14
Participant's inhaler use was assessed on Day 14 by the HCP against a predefined list of critical errors. If a participant made a critical error during this initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The participant was then asked to demonstrate inhaler use. Any errors were recorded by the HCP. If the participant made a critical error then the HCP repeated the demonstration of inhaler use to the participant for a second time. If the participant continued to make a critical error in the use of the inhaler, the HCP demonstrated the correct use of the inhaler and gave verbal instructions one more time and the participant was then asked to demonstrate inhaler use. Instructions are only given to subjects who make a critical error. Any errors made after this final demonstration were recorded.
Measured: Day 14
Time Taken to Correctly Completing Inhaler Use at Day 14
If a participant made a critical error during the initial assessment, the HCP demonstrated the correct use of the inhaler to the participant and gave verbal instructions. The HCP could have demonstrated the use of the inhaler a maximum of three times. Any errors made after this final demonstration were recorded. The time taken for the HCP to train the participant in the correct technique was recorded as T1: the time from when the participants started their demonstration of MDI use until they had completed their demonstration of MDI use (i.e., with no HCP support), T2: the time from when the HCP started to demonstrate/instruct device use until correct use was demonstrated by the participant (up to a maximum of three attempts only). T3 is defined as T1+T2, which is the time from when the participant started to demonstrate MDI use until correct use was demonstrated by the subject (up to a maximum of three attempts following demonstration by HCP).
Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jun 201520 Aug 2015

First posted14 Apr 2015 (estimated)
Study start18 Jun 2015
Primary completion20 Aug 2015
Study completion20 Aug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02416180
Sponsor's protocol ID: 201909
Status last verified: Apr 2017
First submitted: 9 Apr 2015
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study Investigating Critical and Overall Errors Following 14 Days of Treatment With SERETIDE Metered Dose Inhaler (EVOHALER) in Adult Subjects With Controlled Asthma Currently Using the SERETIDE DISKUS Inhaler
ClinicalTrials.gov ID: NCT02416180
Acronym / sponsor ID: 201909
Conditions: Asthma
Keywords: EVOHALER, Asthma, SERETIDE, DISKUS Inhaler, MDI
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 111 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 18 Jun 2015 (actual)
Primary completion: 20 Aug 2015 (actual)
Study completion: 20 Aug 2015 (actual)
First posted: 14 Apr 2015 (estimated)
Results: Posted 7 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A maximum of 110 subjects will be enrolled such that approximately 100 evaluable subjects complete the study. The total duration of the study for each subject will be approximately 21 days.

SERETIDE, EVOHALER and DISKUS are registered trademarks of the GlaxoSmithKline (GSK) group of companies

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SERETIDE EVOHALER	Experimental	Device: SERETIDE MDI, Device: Placebo DISKUS Inhaler, Device: Placebo MDISubjects will switch from their current usual maintenance treatment of SERETIDE via DISKUS Inhaler to an equivalent dose of SERETIDE via the MDI (EVOHALER) at Visit 1. Subjects will use the MDI as 2 inhalations twice daily for approximately 14 days. Subjects will revert back to using SERETIDE DISKUS Inhaler again from Visit 2 (after 14 days) starting with the next scheduled dose.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

>=18 years of age at the time of informed consent.
A diagnosis of asthma as defined by the National Institutes of Health, 2007.
Must be currently treated with SERETIDE via the DISKUS Inhaler and have been maintained on this dose for 3 months prior to Visit 1.
Have controlled asthma defined as a total ACT score >= 20
Must be able to use their DISKUS inhaler correctly. Correct use is defined as making no critical errors during the assessment of DISKUS inhaler use at Visit 1.

Key exclusion criteria (8 listed)

Have a current diagnosis of chronic obstructive pulmonary disease (COPD)
Have experienced an asthma exacerbation within 3 months of Visit 1 or a lower respiratory tract infection within 6 weeks of Visit 1. An exacerbation is defined as worsening asthma requiring any treatment other than rescue salbutamol. This includes requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalisation.
Other Concurrent Diseases: A subject must not have any clinically significant, uncontrolled condition or disease state (such as severe cardiovascular disorders or heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or predisposition to low levels of serum potassium) that, in the opinion of the investigator (in consultation with the GSK Medical Monitor if required), would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study. Please refer to the SERETIDE Product Label for a full list of conditions for special warnings and precautions for use.
Currently taking potent Cytochrome P450 3A4 (CYP 3A4) inhibitors
Currently taking beta-blockers (selective and non-selective).

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
SERETIDE MDICommercially available SERETIDE MDI (EVOHALER) containing fluticasone propionate/salmeterol. Subjects will use MDI as 2 inhalations twice daily at the dose equivalent to their usual maintenance treatment of SERETIDE via DISKUS Inhaler.	Device	SERETIDE EVOHALER
Placebo DISKUS InhalerPlacebo dry powder inhaler to be used to demonstrate the use of DISKUS inhaler at Visit 1	Device	SERETIDE EVOHALER
Placebo MDIClear liquid propellant inhaler to be used to demonstrate the use of MDI at Visit 2	Device	SERETIDE EVOHALER

Primary outcome

Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14
Time frame: Day 14
Participant's inhaler use was assessed on Day 14 by the health care professional (HCP) against a predefined list of critical errors (CEs). Critical errors were defined as errors that were most likely to result in no or only minimal medication being inhaled. The participants were asked to demonstrate their usage of the MDI using a placebo demonstration MDI by HCP, critical or non-critical errors (N-CEs) and even no errors made by the participants while using the MDI were recorded. Critical errors in using the MDI were defined as: failure to remove the cap; failure to shake the device; failure to place the device in mouth; no dose actuated during an inhalation manoeuvre; dose coordination that was so poor that the patient was likely to have received no dose or only received minimal dose. 95% confidence interval (CI) is for the % of participants making at least one critical error after the first assessment of the MDI technique, and was calculated using the exact binomial distribution.

3 secondary outcomes

Percentage of Participants Making at Least One Overall Error After the First Assessment of MDI Technique on Day 14.
Time frame: Day 14
Number of Health Care Professional (HCP) Instructions Required on Day 14
Time frame: Day 14
Time Taken to Correctly Completing Inhaler Use at Day 14
Time frame: Day 14

Results and safety

Results posted to the registry on 7 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluticasone Propionate/Salmeterol MDI	111	110

Primary outcome: Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14

Time frame: Day 14. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Fluticasone Propionate/Salmeterol MDI n = 111
Value	14 (8 to 21)

Population analysed: Intent to Treat (ITT) population: comprised of all participants who were screened and received at least one dose of study medication.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) and serious adverse events (SAE) were collected from the start of the study treatment until the follow-up contact (up to 23 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluticasone Propionate/Salmeterol MDI	1 of 111 (0.9%)	4 of 111 (3.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SERETIDE MDI in people with Asthma, run by GlaxoSmithKline at 7 sites in Germany.

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 9 inclusion and 8 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. 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?

Yes. Results are posted in the registry (first posted 7 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Making at Least One Critical Error After the First Assessment of Metered Dose Inhaler (MDI) Technique on Day 14 (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02416180.

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 30 May 2017.