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.
- 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 disordersMedDRA version: 19.1 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersMedDRA version: 19.1 Level: LLT Classification code 10009028 Term: Chronic obstructive asthma (with obstructive pulmonary disease) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-004564-38-GB
- Lead Sponsor
- Mundipharma Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 369
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
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
- Secondary Outcome Measures
Name Time Method