A study to compare how easily patients with breathing conditions (asthma, chronic obstructive pulmonary disease (COPD) and asthma COPD overlap syndrome) can use two different types of inhaler.

A randomised, open label, two-period, cross-over, multi-centre study to compare correct inhaler handling of fluticasone/ formoterol breath-actuated inhaler (K-haler®) with that of Symbicort® Turbohaler® in subjects with persistent asthma, ACOS or COPD. - Preference and Ease of use of Fluticasone/FormotERol K-haler (Preffer) study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004564-38-GB

Enrollment

368

Registered

2015-03-30

Start date

2015-05-27

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Asthma-COPD Overlap Syndrome (ACOS) and Chronic Obstructive Pulmonary Disease. MedDRA version: 19.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1 Level: LLT Classification code 10003555 Term: Asthma bronchial

Interventions

Trade Name: flutiform® 50 micrograms / 5 micrograms per actuation pressurised inhalation, suspension Product Name: Fluticasone/formoterol BAI 50/5 µg Product Code: K-ha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent/assent. 2. Male and female subject’s =18 years old. 3. Female subjects less than one year post-menopausal must have a negative urine pregnancy test prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), true sexual abstinence, where this is in line with the preferred and usual lifestyle of the subject, or vasectomized partner. Note: Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for duration of study, and withdrawal are not acceptable methods of contraception). 4. Documented history of asthma, ACOS or COPD for = 6 months prior to Visit 1. 5. Subjects currently using Seretide® Accuhaler®/ Viani® Diskus® (100/50 bid, 250/50 bid or 500/50 bid) for at least 3 months prior to Visit 1 and naïve to Turbohaler® (whether containing SABA, ICS or ICS-LABA) and K-haler. 6. Subject currently uses a specific reliever(s) device(s) for at least 3 months prior to Visit 1. 7. Can perform spirometry adequately. 8. Willing and able to attend all study visits. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 221 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 147

Exclusion criteria

Exclusion criteria: 1. Any severe chronic respiratory disease other than asthma, ACOS or COPD. 2. Subjects that have previously used Turbohaler® (whether containing SABA, ICS or ICS-LABA) and/or the K-haler®. 3. Subjects currently using Seretide® Accuhaler®/Viani® Diskus® 500/50 bid in whom the Investigator considers it a risk to patient safety to switch to Symbicort® 400/12 bid or fluticasone/formoterol 250/10 bid. 4. Subjects currently using any fixed dose ICS/LABA other than Seretide® Accuhaler®. 5. Near fatal or life-threatening (including intubation) asthma, ACOS or COPD within one year of Visit 1. 6. Use of systemic (injectable or oral) corticosteroid medication within 4 weeks of Visit 1. 7. Evidence of a clinically unstable disease that, in the Investigator’s opinion, may confound between period comparisons or would put the Subject at risk through study participation. 8. A clinically significant upper or lower respiratory infection within 4 weeks prior to Visit 1. 9. Known or suspected sensitivity to study drug or excipients. 10. Current participation in a clinical study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To show superiority in correct inhaler handling of fluticasone/ formoterol K-haler® versus Symbicort® Turbohaler®, following instruction by a HCP as determined by all critical steps being performed correctly 12 weeks after training.; Secondary Objective: 1. To compare successful device handling after subjects read the respective IFUs. 2. To compare the ease of use of and preference for each device versus Seretide® Accuhaler®. 3. To compare the subject's perception of their device. ; Primary end point(s): The proportion of subjects that can perform all critical steps correctly 12 weeks after training* (critical steps are defined in Appendix 18.10 of the study Protocol). * Step 5 of the K-haler assessment is defined as the ability to trigger the inhaler. ;Timepoint(s) of evaluation of this end point: 12 weeks.	—

Measure

Time frame

Main Objective: To show superiority in correct inhaler handling of fluticasone/ formoterol K-haler® versus Symbicort® Turbohaler®, following instruction by a HCP as determined by all critical steps being performed correctly 12 weeks after training.; Secondary Objective: 1. To compare successful device handling after subjects read the respective IFUs. 2. To compare the ease of use of and preference for each device versus Seretide® Accuhaler®. 3. To compare the subject's perception of their device. ; Primary end point(s): The proportion of subjects that can perform all critical steps correctly 12 weeks after training* (critical steps are defined in Appendix 18.10 of the study Protocol). * Step 5 of the K-haler assessment is defined as the ability to trigger the inhaler. ;Timepoint(s) of evaluation of this end point: 12 weeks.

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Secondary

Measure	Time frame
Secondary end point(s): 1. The proportion of subjects that can perform all steps correctly when using the inhaler device 12 weeks after training.* 2. The proportion of subjects performing all critical steps correctly when using the inhaler device after reading the IFU on day 1.* 3. The proportion of subjects performing all steps correctly when using the inhaler device after reading the IFU on day 1.* 4. The proportion of subjects performing all critical steps correctly when using the inhaler device after the first instruction on use by the HCP at day 1.* 5. The proportion of subjects performing all steps correctly when using the inhaler device after the first instruction on use by the HCP at day 1.* 6. The proportion of subjects requiring 1, 2, 3, 4, 5, 6, 7 or 8 instructions from the HCP to perform all steps correctly at day 1.* 7. The proportion of subjects requiring 1, 2, 3, 4, 5, 6, 7 or 8 instructions from the HCP to perform all steps correctly at week 12.* 8. The proportion of subjects at the end of the 12 week Treatment Period describing the study inhaler compared to Seretide® Accuhaler® as being "much harder to use", "a bit harder to use", "about as easy to use/don't know", "bit easier to use", "much easier to use". 9. The proportion of subjects at the end of the 12 week Treatment Period reporting preference as "I prefer: fluticasone/formoterol K-haler® (or Symbicort® Turbohaler®)", "I prefer Seretide® Accuhaler®", "no preference/don't know". 10. The proportion of subjects at the end of the 12 week Treatment Period who report that they are "completely satisfied", "mostly satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied/don't know", "somewhat dissatisfied", "mostly dissatisfied" and "extremely dissatisfied" in response to each of 5 Patient Perception of Device questions.	—

Measure

Time frame

Secondary end point(s): 1. The proportion of subjects that can perform all steps correctly when using the inhaler device 12 weeks after training.* 2. The proportion of subjects performing all critical steps correctly when using the inhaler device after reading the IFU on day 1.* 3. The proportion of subjects performing all steps correctly when using the inhaler device after reading the IFU on day 1.* 4. The proportion of subjects performing all critical steps correctly when using the inhaler device after the first instruction on use by the HCP at day 1.* 5. The proportion of subjects performing all steps correctly when using the inhaler device after the first instruction on use by the HCP at day 1.* 6. The proportion of subjects requiring 1, 2, 3, 4, 5, 6, 7 or 8 instructions from the HCP to perform all steps correctly at day 1.* 7. The proportion of subjects requiring 1, 2, 3, 4, 5, 6, 7 or 8 instructions from the HCP to perform all steps correctly at week 12.* 8. The proportion of subjects at the end of the 12 week Treatment Period describing the study inhaler compared to Seretide® Accuhaler® as being "much harder to use", "a bit harder to use", "about as easy to use/don't know", "bit easier to use", "much easier to use". 9. The proportion of subjects at the end of the 12 week Treatment Period reporting preference as "I prefer: fluticasone/formoterol K-haler® (or Symbicort® Turbohaler®)", "I prefer Seretide® Accuhaler®", "no preference/don't know". 10. The proportion of subjects at the end of the 12 week Treatment Period who report that they are "completely satisfied", "mostly satisfied", "somewhat satisfied", "neither satisfied nor dissatisfied/don't know", "somewhat dissatisfied", "mostly dissatisfied" and "extremely dissatisfied" in response to each of 5 Patient Perception of Device questions.

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Countries

Germany, United Kingdom

Contacts

Public ContactMedical Operations

Mundipharma Research Limited

info@contact-clinical-trials.com+441223424900

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026