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.

Phase 1

Conditions: Asthma, Asthma-COPD Overlap Syndrome (ACOS) and Chronic Obstructive Pulmonary Disease.
MedDRA version: 19.0Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0Level: LLTClassification code 10009028Term: Chronic obstructive asthma (with obstructive pulmonary disease)System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2014-004564-38-DE

Lead Sponsor: Mundipharma Research Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 368

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>2. To compare the ease of use of and preference for each device versus Seretide® Accuhaler®.<br>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).<br><br>* 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.

Secondary Outcome Measures

Name	Time	Method

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