| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Asthma, Asthma-COPD Overlap Syndrome (ACOS) and Chronic Obstructive Pulmonary Disease. |
|
| E.1.1.1 | Medical condition in easily understood language |
| Long term breathing problems (Asthma, Chronic Obstructive Pulmonary Disease and a combination of the two) |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 19.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10003555 |
| E.1.2 | Term | Asthma bronchial |
| E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 19.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10009033 |
| E.1.2 | Term | Chronic obstructive pulmonary disease |
| E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 19.0 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10009028 |
| E.1.2 | Term | Chronic obstructive asthma (with obstructive pulmonary disease) |
| E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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. |
|
| E.2.2 | Secondary objectives of the trial |
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. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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. |
|
| E.5 End points |
| E.5.1 | 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. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | 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.
11. The proportion of subjects at the end of the 12 week Treatment Period responding as "completely satisfied" or "mostly satisfied" in response to each of 5 Patient Perception of Device questions.
12. Study medication use (compliance) during Treatment Period.
* Step 5 of the K-haler assessment is defined as the ability to trigger the inhaler. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Day 1 or week 12 depending on endpoint (as specified in E.5.2). |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 2 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 12 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 28 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 28 |
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