| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| poorly (ie inadequately)controlled asthma patients. |
| pazienti adulti e adolescenti con asma |
|
| E.1.1.1 | Medical condition in easily understood language |
| Adult and Adolescent Patients With Asthma |
| pazienti adulti e adolescenti con asma |
|
| 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 | 19.0 |
| 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 |
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. |
| L’obiettivo primario di questo studio è di dimostrare la superiorità di QMF149 150/80 microgrammi o.d. (alla sera) somministrato con Concept1 rispetto a MF 200 microgrammi o.d. (alla sera) somministrato con Twisthaler®, in termini di FEV1 pre-dose dopo 12 settimane di trattamento, in pazienti adulti e adolescenti con asma |
|
| 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. |
| L’obiettivo secondario principale è di dimostrare la superiorità di QMF149 150/80 microgrammi rispetto a MF 200 microgrammi o.d. in termini di ACQ-7 dopo 12 settimane di trattamento |
|
| 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 at screening 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.
|
Pazienti adulti con asma che sono sintomatici allo screening nonostante il trattamento con la terapia esistente. I pazienti devono avere un punteggio ACQ-7 ≥1.5 alla Visita 101 e alla Visita 102 (cioè inadeguatamente controllato).
Pazienti adolescenti con asma:
• pazienti che stanno assumendo basse dosi di ICS (senza LABA), che sono sintomatici allo screening nonostante il trattamento con ICS. Questi pazienti devono avere un punteggio ACQ-7 ≥1.5 alla Visita 101 e alla Visita 102 (cioè inadeguatamente controllato).
• Pazienti che stanno assumendo una dose bassa di ICS/LABA, possono essere inclusi solo se il punteggio ACQ-7 ≥1 e < 1.5 alla Visita 101 (cioè adeguatamente controllato). Comunque il punteggio ACQ-7 deve essere ≥1.5 alla visita 102.
FEV1 pre-dose ≥ 60% e < 90% del valore predetto normale
Reversibilità di FEV1 ≥ 12% e ≥ 200 mL
|
|
| 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: Exacerbation requiring systemic steroids, hospitalization (> 24
hours) or emergency room visit (≤24 hours) within 6 months, prior to visit 1.
• 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. |
Donne in gravidanza/madri in allattamento
Donne in età fertile (a meno che non usino un’adeguata contraccezione)
Pazienti con anamnesi di patologia polmonare cronica diversa dall’asma comprese, ma non limitate a, BPCO, sarcoidosi, patologia polmonare interstiziale, fibrosi cistica, bronchiectasia clinicamente significativa, o tubercolosi attiva.
Pazienti che siano attualmente fumatori o che inalino prodotti derivati dal tabacco (incluso le sigarette elettroniche) nei 6 mesi precedenti la visita 1 o ex-fumatori con una storia di fumo di ≥ 10 pacchetti per anno.
Pazienti che hanno avuto un attacco/esacerbazione di asma che ha richiesto steroidi sistemici o ricovero ospedaliero (>24 ore) o visita in pronto soccorso (≤ 24 ore) come segue:
• Per adulti: nelle 6 settimane precedenti la visita 1 (screening). Se i pazienti che hanno avuto un attacco/esacerbazione di asma che ha richiesto steroidi sistemici o ricovero ospedaliero o visita in pronto soccorso tra la visita 1 e la visita 102, possono essere ri-selezionati 6 settimane dopo il ricovero dall’esacerbazione.
• Per gli adolescenti: esacerbazione di asma che ha richiesto steroidi sistemici o ricovero ospedaliero (>24 ore) o visita in pronto soccorso (≤ 24 ore) nei 6 mesi precedenti la visita 1.
Pazienti con problemi ereditari di intolleranza al lattosio, carenza di Lapp lattasi o malassorbimento di glucosio-galattosio o una nota intollerenza al lattosio o derivati del latte
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary Outcome Measure:
• trough FEV1 [Time Frame: week 12] [Designated as safety issue: No]
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.
Forced Expiratory Volume in 1 second (FEV1) is the amount of air
which can be forcibly exhaled from the lungs in the first second of a
forced exhalation, measured by spirometry. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
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.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 | 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 | 10 |
| 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 |
|
| 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 | |
| E.8.9.1 | In the Member State concerned months | 16 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 17 |
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