| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| 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 demonstrate the superiority of either QMF149 150/160 μg delivered via Concept1 o.d. (in the evening) to MF 400 μg o.d (in the evening) delivered via Twisthaler® or QMF149 150/320 μg delivered via Concept1 o.d. (in the evening) to MF 800 μg delivered via Twisthaler® (delivered as 400 μg b.i.d.) in terms of FEV1 at 26 weeks. |
|
| E.2.2 | Secondary objectives of the trial |
To compare QMF149 150/160μg o.d. to MF 400μg o.d or QMF149 150/320μg o.d. to MF 800 μg (delivered as 400 μg b.i.d.)in terms of:
- Through FEV1 at week 52
- Pre-dose FEV1 at week 4 and 12
- FEV1, FVC and FEF over 52 weeks of treatment.
- PEF over 26 and 52 weeks
- ACQ-7 at week 4, 12, 26 and 52 weeks
- Percentage patients with MID of ACQ>=0,5 at week 26 and 52
- daily e-diary over 52 weeks
-rescue medication use over 26 and 52 weeks
- asthma exacerbation over 52 weeks
- % rescue medication free days over 26 and 52 weeks
-quality of life assessed by AQLQ-S 12 at 52 weeks
- incidence of composite endpoint of serious asthma outcomes
- Adverse event, vital signs, ECG and laboratory analysis
To compare QMF149 150/320μg with salmeterol xinafoate /fluticasone propionate 50/500μg via Accuhaler® for all the listed secondary endpoints above as well as through FEV 1 at week 26: |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Patients with a diagnosis of asthma, for a period of at least 1 year
prior to Visit 1 (Screening)
2. Patients who have used medium or high dose ICS or low dose of
LABA/ICS combinations for asthma for at least 3 months and at stable
doses for at least 1 month prior to Visit 1
3. Patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102
(prior to double-blind treatment) and qualify for treatment with medium
or high dose LABA/ICS
4. Pre-bronchodilator ≥ 50% FEV1 of < 85% of the predicted normal
value for the patient after withholding bronchodilators at both Visit 101
and 102,according to ATS/ERS criteria.
• Withholding period of bronchodilators prior to spirometry: SABA for ≥
6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, SAMA
for ≥ 8 hours, xanthines >=07days.
• A one-time repeat/ re-testing of percent predicted FEV1
(prebronchodilator FEV1) is allowed at visit 101 and at visit 102.
Spacer devices are permitted for reversibility testing only.
5. Patients who demonstrate an increase in FEV1 of 12% and 200 mL
within 30 minutes after administration of 400 μg salbutamol/360 μg
albuterol (or equivalent dose) at Visit 101 All patients must perform a
reversibility test at Visit 101 If reversibility is not demonstrated at Visit
101:
- Reversibility should be repeated once
- Patients may be permitted to enter the study with historical evidence
of reversibility that was performed according to ATS/ERS guidelines
within 2 years prior to Visit
- Alternatively, patients may be permitted to enter the study with a
historical positive bronchoprovocation test that was performed within 2
years prior to Visit 1. |
|
| E.4 | Principal exclusion criteria |
Exclusion Criteria:
• Patients who have smoked or inhaled tobacco products within the 6
month period prior to Visit 1, or who have a smoking history of greater
than 10 pack years. This includes or use of nicotine inhalers such as ecigarettes
at the time of Visit 1
• Patients who have had an asthma attack/exacerbation requiring
systemic steroids or hospitalization or emergency room visit within 6
weeks of Visit 1 (Screening)
• Patients who have ever required intubation for a severe asthma
at tack/exacerbation.
•Patients who have a clinical condition which is likely to be worsened by
ICS administration (e.g. glaucoma, cataract and fragility fractures) who
are according to investigator's medical judgment at risk participating in
the study).
• Patients who have had a respiratory tract infection or asthma
worsening as determined by the investigator within 4 weeks prior to
Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be
rescreened 4 weeks after recovery from their respiratory tract infection
or asthma worsening.
• Patients with a history of chronic lung diseases other than asthma,
including (but not limited to) COPD, sarcoidosis, interstitial lung disease,
cystic fibrosis, clinically significant bronchiectasis and active
tuberculosis.
• Patients with severe narcolepsy and/or insomnia.
• Patients who have a clinically significant ECG abnormality at Visit 101
(Start of Run- In epoch) and at any time between Visit 101 and
Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at
Visit 101 (via central reader) should be clinically assessed by the
investigator with supportive documentation.
• Patients with a history of hypersensitivity tolactose, any of the study
drugs or to similar drugs within the class including untoward reactions
to sympathomimetic amines or inhaled medication or any component
thereof
• Patients who have not achieved an acceptable spirometry results at
Visit 101 in accordance with American Thoracic Society/European
Respiratory Society (ATS/ERS) criteria for acceptability and repeatability
(rescreening allowed only once).
Repeat spirometry may be allowed once in an adhoc visit if the
spirometry did not qualify due to ATS/ERS criteria. If the patient fails
the repeat assessment, the patient may be rescreened once
• Patients on Maintenance Immunotherapy (desensitization) for
allergies or less than 3 months prior to Visit 101 or patients on
Maintenance Immunotherapy for more than 3 months prior to Visit 101
but expected to change throughout
the course of the study.
•Women of child-bearing potential, defined as all women physiologically
capable of becoming pregnant, unless they are using highly effective
methods of contraception during dosing of study treatment and for 30
days after stopping of study
treatment.
- LAMA within 3 months prior to visit 101 |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Comparison between QMF149 and Mometasone furoate in terms of FEV1. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
| Comparison between QMF149 and Mometasone furoate in terms of ACQ-7 |
|
| 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 | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| 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 | 5 |
| 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 | 5 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 180 |
| 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 |
| Bulgaria |
| China |
| Colombia |
| Croatia |
| Czech Republic |
| Egypt |
| Estonia |
| Germany |
| Guatemala |
| Hungary |
| India |
| Ireland |
| Japan |
| Korea, Republic of |
| Latvia |
| Lithuania |
| Mexico |
| Poland |
| Romania |
| Russian Federation |
| Serbia |
| Slovakia |
| South Africa |
| United Kingdom |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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 | 0 |
| 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 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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