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 |
|
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 |
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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 |
The primary objective of this study is to demonstrate the superiority of QMF149
150/80 microgram o.d. (in the evening) delivered via Concept1 compared with
MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of
trough FEV1 after 12 weeks of treatment in adults and adolescents. |
|
E.2.2 | Secondary objectives of the trial |
The key secondary objective of this study is to demonstrate the superiority of QMF149
150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks
of treatment. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with a documented diagnosis of asthma for a period of at least
3 months prior to Screening Visit
- Patients who have used low dose ICS , with or without controller (ie,
LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1
month prior to Screening Visit
-Adult patients who are symptomatic despite treatment with existing
therapy.
Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102
(inadequately
controlled).
- Adolescent patients : If taking only ICS (without LABA) and are
symptomatic at screening despite treatment with low doses of ICS.
These patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102
. If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and <1.5 at
Visit 101: they must have ACQ-7 score≥1.5 at Visit 102 ( prior to
randomization).
- Pre-bronchodilator FEV1≥ 60 % and < 90 % of the predicted normal
value for the patient after withholding bronchodilators at both Visits 101 and 102
- Patients who demonstrate an increase in FEV1 of 12% and ≥ 200 mL
within 30 minutes after administration of 400 microgram
salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101. |
|
E.4 | Principal exclusion criteria |
- Patients who have smoked or inhaled tobacco products (including
electronic cigarettes) within the 6 month period prior to Visit 1, or who
have a smoking history of greater than or equal to 10 pack year.
- Patients who have had an asthma attack/exacerbation requiring
systemic steroids or hospitalization (> 24 hours) or emergency room
visit (≤ 24 hours) as follows:
For adults: within 6 weeks of Screening Visit. If patients experience an
asthma attack/exacerbation requiring systemic steroids or emergency
room visit between Visit 1 and Visit 102 they may be re-screened 6
weeks after recovery
from the exacerbation
For adolescents: Severe asthma attack/exacerbation requiring systemic
corticosteroid in the last 6 months or hospitalization (> 24 hours) due
to severe asthma attack/exacerbation requiring systemic corticosteroids
in the last 6 months or emergency room visit (≤24 hours) due to severe
asthma attack/exacerbation requiring systemic corticosteroids within
the last 6 months..
- Patients who ever required intubation for a severe asthma
attack/exacerbation
- Patients with a clinical condition (eg. glaucoma, cataract and fragility
fractures) which may be worsened by ICS administration (according to
investigator's medical judgment )
- Patients who have had a respiratory tract infection or asthma
worsening within 4 weeks prior to Screening Visit or between Visit 1and
Visit 102. Patients may be re-screened 4 weeks after recovery from their
respiratory tract infection or
asthma worsening.
- Patients with any chronic conditions affecting the upper respiratory
tract (eg.chronic sinusitis) which in the opinion of the investigator may
interfere with the study.
- 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 Type I diabetes or uncontrolled Type II diabetes.
- Patients with narcolepsy and/or insomnia.
- 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.
- Patients with diagnosed rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption or with known intolerance to lactose or milk products. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- To demonstrate the superiority of QMF149 150/80 microgram o.d. (in
the evening) delivered via Concept1 compared with MF 200 microgram
o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1
after 12 weeks of treatment in adults and adolescents. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- ACQ-7 after 4 weeks of treatment and after 12 weeks of treatment
- Trough FEV1 at day
- Pre-dose FEV1 at week 4
- FVC over 12 weeks
- PEF over 4 and 12 weeks
- Percentage of patients with MID at week 12
- Daily e-diary over 12 weeks
- Rescue medication use over 12 weeks
- Percentage of rescue medication free days over 12 weeks
- Asthma exacerbation over 12 weeks
- Quality of life assessed by AQLQ-S 12
- Composite endpoint of serious asthma outcomes |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time points for each secondary endpoint is included in section E 5.2 |
|
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 | 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 | 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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 82 |
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 |
Bulgaria |
Chile |
Colombia |
Estonia |
Germany |
Hungary |
India |
Italy |
Japan |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Peru |
Philippines |
Poland |
Romania |
Russian Federation |
Slovakia |
South Africa |
Sweden |
Thailand |
Vietnam |
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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
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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 | 17 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 22 |