| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| 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 | 17.0 |
| E.1.2 | Level | SOC |
| E.1.2 | Classification code | 10038738 |
| E.1.2 | Term | Respiratory, thoracic and mediastinal disorders |
| E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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| 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 |
This is a 2 stage study. The primary objectives of the study are as follows:
•stage 1: to determine the proportion of patients achieving device mastery by the end of step 3 of a 6 step standardized device training protocol for empty SPIROMAX is superior to empty TURBOHALER devices. Device mastery is defined as absence of nurse-observed errors.
•stage 2: to determine whether the proportion of patients maintaining device mastery, in patients receiving ICS/LABA via BF SPIROMAX, is superior to ICS/LABA received via SYMBICORT TURBOHALER. Maintenance of device mastery is defined as absence of nurse-observed errors after 12 weeks of device use.
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| E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study-Stage 1 of this study:
•proportion of patients achieving device mastery by step 1
•proportion of patients achieving device mastery by step 2
•number of steps required to achieve device mastery
•number of nurse-observed errors
•number of inhaler technique errors
•patient preference of device using the Patient Satisfaction and Preference Questionnaire
Stage 2 of this study:
•proportion of patients maintaining device mastery relating to dose preparation errors
•total no of observed errors (nurse and technology [Vitalograph™ pneumotrac spirometer])
•number of technology-observed errors (Vitalograph pneumotrac spirometer)
•no of handling errors
•difference in number of handling errors identified following training using the patient information leaflet at stage 1 and after 12 weeks of treatment (end of stage 2)
•treatment adherence assessed by device counters
•efficacy of budesonide/formoterol treatment |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
a. Written informed consent/assent is obtained: For adult patients, written informed consent signed and dated by the patient before conducting any study related procedures.
b. The patient is a man or woman 18 through 75 years of age as of the screening visit.
c. The patient has a diagnosis of asthma in accordance with Global Initiative for Asthma (GINA) criteria as evidenced by a UK quality outcome framework approved Read code (UK diagnostic coding
system).
d. The patient is receiving step 3 or 4 therapy for asthma as defined by the BTS guidelines (daily doses of BDP-equivalent ICS ≥800 mcg to 2000 mcg as part of fixed or free combinations with LABA).
e. The patient does not have an ongoing asthma exacerbation.
f. Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the
duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD) known to have a failure rate of less than 1% per year,
steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.
g. The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow up
evaluation as specified in this protocol.
h. The patient is SPIROMAX and TURBOHALER naïve (no use of a TURBOHALER device in the last 6 months, minimizing carryover from prior device use).
The following criteria apply to stage 2 of this study:
i. Patient has uncontrolled or partly controlled asthma (using GINA criteria).
j. Patient has demonstrated at least 1 error in current device inhaler technique.
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| E.4 | Principal exclusion criteria |
a. The patient has any clinically significant uncontrolled medical condition (treated or untreated).
b. The patient has participated in a Teva sponsored clinical study with BF SPIROMAX in the last 6 months.
c. The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
d. The patient has used an investigational drug within 1 month before the screening visit.
e. The patient has received OCS and/or antibiotics for a lower respiratory condition in the 2 weeks preceding visit 1A (proxy measure for identifying an asthma exacerbation and/or lower respiratory
infection, suggestive of altered inspiratory capabilities).
f. The patient is currently receiving any OCS (including long or short courses).
g. The patient has a significant chronic lower respiratory tract disease other than asthma eg chronic obstructive pulmonary disease (COPD), cystic fibrosis or interstitial lung disease. Conditions that are
not predominant, such as minor degrees of bronchiectasis, are not a reason for exclusion.
The following criteria apply to stage 2 of this study:
h. The patient is unable to achieve mastery of both BF SPIROMAX and SYMBICORT TURBOHALER.
i. The patient has controlled asthma (using GINA criteria).
j. The patient demonstrates an absence of errors in current device inhaler technique. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Measures and Endpoints: This is a 2-stage study. The primary measures and endpoints of the study are as follows:
•stage 1: proportion of patients achieving device mastery. Device mastery is defined as absence of nurse-observed errors by the end of step 3 of a 6 step standardized device training protocol for empty SPIROMAX compared to empty TURBOHALER
•stage 2: proportion of patients maintaining device mastery. Maintenance of device mastery is defined as absence of nurse-observed errors after 12 weeks of device use.
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Data to evaluate the stage 1 endpoint will be collected during visit 1 on day 1
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| E.5.2 | Secondary end point(s) |
Secondary Measures and Endpoints:
The secondary measures and endpoints for this study are as follows:
Stage 1
•proportion of patients achieving device mastery by step 1
•proportion of patients achieving device mastery by step 2
•number of steps required to achieve device mastery
•number of nurse-observed errors
•number of inhaler technique errors
•PASAPQ score
Stage 2
•proportion of patients maintaining device mastery relating to dose preparation errors
•total number of observed errors (nurse and technology [Vitalograph pneumotrac spirometer])
•number of technology-observed errors (Vitalograph pneumotrac spirometer)
•number of handling errors
•difference in number of handling errors identified following training using patient information leaflet at stage 1 and after 12 weeks of treatment (end of stage 2)
•treatment adherence (assessed by device counters)
•efficacy of budesonide/formoterol treatment as assessed by the following:
-change in 6 item ACQ (excluding FEV1 question) from baseline to 4, 8, and 12 weeks
-change in 7 item ACQ (including FEV1 question) from baseline to week 12
-time to treatment failure (defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection)
-number of severe asthma exacerbations (defined as a hospitalization or emergency room attendance for asthma, or an acute course of OCS)
-impact of maintaining device mastery on time to treatment failure (defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection) and asthma control
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Data to evaluate the stage 2 endpoint will be collected during visit 2 at 12 weeks |
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| 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 | Yes |
| E.6.5 | Efficacy | Yes |
| 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 |
| inhaler technique mastery and maintenance of mastery |
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| 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 | Yes |
| 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 | 75 |
| E.8.5 | The trial involves multiple Member States | No |
| 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
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| 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 | 10 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
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