| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Inadequately controlled asthma |
|
| E.1.1.1 | Medical condition in easily understood language |
| Inadequately controlled asthma |
|
| 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 | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10003553 |
| E.1.2 | Term | Asthma |
| 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 evaluate the effectiveness of FF/UMEC/VI with CIS on improving asthma control compared with FP/SAL+TIO after 24 weeks of treatment |
|
| E.2.2 | Secondary objectives of the trial |
-To evaluate the effectiveness of FF/UMEC/VI with CIS on reducing asthma exacerbations compared with the FP/SAL+TIO after 24 weeks
of treatment
-To evaluate the effectiveness of FF/UMEC/VI with CIS on improving health-related quality of life compared with the FP/SAL+TIO after 24
weeks of treatment
-To compare the adherence to FF/UMEC/VI ELLIPTA with CIS with FP/SAL DISKUS
-To evaluate the effectiveness of FF/UMEC/VI with CIS on improving lung function compared with the FP/SAL+TIO after 24 weeks of treatment |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Participants are eligible to be included in the study only if all of the following criteria apply:
General
1. Participants must have their own Android or IOS mobile device (e.g. smart phone or tablet) and a data package suitable for the installation and running of the App and sending and receiving data. Data used by the CIS is approximately 1MB per month as a maximum; this is less data than a 1 minute video streamed from YouTube (2MB).
2. Participants must be willing and able to download the app on their personal mobile device and keep it turned on for the duration of the study. This will also require Bluetooth to be turned on for duration of the study. Participants will also have to turn on mobile data for the app for the duration of study; unless travelling and when extra data roaming costs could be incurred.
Age
3. Participant must be 18 years of age or older at the time of signing the informed consent.
Type of Participant and Disease Characteristics
4. Diagnosis:
- Participants with a documented diagnosis of asthma by a respiratory physician.
OR
- Participants with a documented asthma diagnosis by their General Practitioner (GP) are required to have spirometry consistent with the diagnosis of asthma (e.g., reduced FEV1, reduced FEV1/forced vital capacity (FVC), or variable airflow obstruction) at or before Visit 0.
5. Ability to perform spirometry: Participants who are able to perform spirometry that conforms to ATS/ERS technical standards at Visit 0 or Visit 1 [Miller 2005].
6. Current Asthma Maintenance Therapy: Participants are eligible if they require daily ICS/LABA therapy (with a stable total daily dose of ICS of >250 mcg/day fluticasone propionate [FP, or equivalent]) for at least 4 weeks prior to screening.
Please refer to the SRM for examples of acceptable doses of commonly prescribed ICS medication. Dosing regimen (once or twice daily to equal the total daily dose) should be restricted to the current local product labels/treatment guidelines.
7. Symptomatic: Subjects with inadequately controlled asthma (ACT total score <20) despite ICS/LABA maintenance therapy at Visit 1.
Sex
8. Male or Female participants
a. Female participants:
A female participant is eligible to participate if she is not pregnant (refer protocol), not breastfeeding, and at least one of the following conditions applies:
(i) Not a woman of childbearing potential (WOCBP) as defined in the protocol
OR
(ii) A WOCBP who agrees to follow the contraceptive guidance in protocol during the treatment period and for at least 5 days after the last dose of study treatment.
The investigator is responsible for ensuring that participant understands how to properly use these methods of contraception.
Informed Consent
9. Capable of giving signed informed consent as described in the protocol), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. |
|
| E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. Concurrent respiratory disorders: Participants with current evidence of
pneumonia, active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases including COPD or abnormalities other than asthma.
2. Other diseases/abnormalities: Participants with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation (e.g.very low body mass index [BMI] or severely malnourished), or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
3. Unstable or life threatening cardiac disease: Participants with any of the following at screening would be excluded:
- Myocardial infarction or unstable angina in the last 6 months
- Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months
- New York Heart Association (NYHA) Class IV Heart failure
4. Moderate or severe hepatic impairment in participants receiving high dose ICS.
5. Hypersensitivity: Participants with a history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate are excluded from participation in this study
6. Antimuscarinic effects: Participant with a medical condition such as narrow-angle glaucoma, urinary retention, prostatic hypertrophy or bladder neck obstruction should only be included if in the opinion of the Investigator the benefit outweighs the risk and that the condition would not contraindicate study participation.
Questionable validity of consent:
7. Participant with active uncontrolled psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
Prior/Concomitant Therapy
8. Investigational products: 30 days or within 5 drug half-lives of the investigational drug (whichever is longer).
9. Medication prior to spirometry: Participants who are medically unable to withhold their albuterol/salbutamol for the 6-hour period required prior to spirometry testing at each study visit.
Other Exclusions
10. Smokers: Smokers will be excluded as follows:
- Current smokers (defined as participants who have used inhaled tobacco products within the 12 months prior to screening [i.e., cigarettes, e-cigarettes/vaping, cigars or pipe tobacco]).
- Former smokers with a smoking history of ≥ 10 pack years (e.g., ≥20
cigarettes/day for 10 years).
11. Non-compliance: Participants unable to comply with the study procedures due to infirmity, disability, or geographic location.
12. Affiliation with Investigator site: Study Investigators, sub-Investigators, study coordinators, employees of a participating Investigator or study site, or immediate family members of the aforementioned that is involved with this study.
13. Inability to read: In the opinion of the Investigator, any participant who is unable to read and/or would not be able to complete study related materials.
14. Recent participation in a clinical trial: The following will be excluded:
- Participants who have taken part in more than 1 clinical trial in the 12 months prior to Visit 1.
AND/OR
- Participants who have taken part in any of the following clinical trials in the 12 months prior to Visit 1:
o A clinical trial including audio and/or visual reminders for the
participant to take their study treatment.
o Any clinical trial during the 4 weeks prior to Visit 1.
o GSK study 207040. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Percentage of participants who have either an
asthma control test (ACT) total score of ≥20 or
an increase from baseline of ≥3 in ACT total
score at Week 24. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
Annualised rate of moderate/severe asthma
exacerbations at week 24
Percentage of participants who have a
decrease from baseline of ≥4 in St George’s
Respiratory Questionnaire (SGRQ) total score
at Week 24.
Percentage of ELLIPTA versus DISKUS doses
taken as prescribed over the 24-week treatment period.
Change from baseline in trough FEV1 at Week
24. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 | 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 | No |
| 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 | No |
| 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 | 4 |
| 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 | 8 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 59 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Argentina |
| Australia |
| Canada |
| Korea, Republic of |
| Mexico |
| Russian Federation |
| United States |
|
| 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 | 2 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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