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NCT02571777 | SNCTP000001875

Studie zur Beurteilung der Wirksamkeit und Sicherheit von QVM149 bei Patienten mit Asthma

Data source: BASEC (Imported from 19.07.2019), WHO (Imported from 07.07.2019)
Changed: 12.07.2019
Disease category: Atemwegserkrankungen (nicht Krebs)

Brief description of trial (Source of data: BASEC)

Wir machen diese Studie, um die Wirkung und Sicherheit von zwei verschiedenen Dosierungen von QVM149 bei Patienten mit Asthma zu untersuchen. In der Studie werden die zwei verschiedenen Dosierungen von QVM149 mit zwei verschiedenen Dosierungen von QMF149 und einer Kombinationstherapie mit Salmeterol und Fluticasonpropionat verglichen. In der Studie wird untersucht, welche dieser Substanzen zu einer besseren Linderung der Asthma-Symptome führt und Ihre Lungenfunktion verbessert. Die Studie dauert ca. 52 Wochen. Geplant sind 9 Visiten und 9 Telefongespräche. Jede Visite dauert etwa 2 Stunden. Während der Studie werden verschiedene Untersuchung (z.B. Lungenfunktionstest, Blut-/Urinproben) sowie Befragungen (z.B. zu Ihren Asthmasymptomen und –anfällen in Form von Fragebögen) durchgeführt.

Health conditions investigated (Source of data: BASEC)

Asthma

Health conditions (Source of data: WHO)

Asthma

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

• QVM149 via Breezhaler® in einer Dosis von 150/50/80 μg einmal täglich
• QVM149 via Breezhaler® in einer Dosis von 150/50/160 μg einmal täglich
• QMF149 via Breezhaler® in einer Dosis von 150/160 μg einmal täglich
• QMF149 via Breezhaler® in einer Dosis von 150/320 μg einmal täglich
• Salmeterol/Fluticasonpropionat via Diskus® in einer Dosis von 50/500 μg zweimal täglich

Interventions (Source of data: WHO)

Drug: QVM149;Drug: QMF149

Criteria for participation in trial (Source of data: BASEC)

1. Männliche/weibliche Patienten mit Asthma
2. Zwischen 18-75 Jahre
3. Patienten müssen einen bestimmten Lungenfunktionswert aufweisen

Exclusion criteria (Source of data: BASEC)

1. Patienten, welche an einer anderen chronische Lungenerkrankung als Asthma leiden
2. Patienten mit Erkrankung, welche wahrscheinlich durch die Verabreichung inhalativer Kortikosteroide verschlechtert wird
3. Schwangere und stillende Frauen

Inclusion/Exclusion Criteria (Source of data: WHO)


Inclusion Criteria:

- Patients with a diagnosis of asthma, (GINA 2015) for a period of at least 1 year prior
to Visit 1 (Screening).

- Patients who have used medium or high dose of ICS/LABA combinations for asthma for at
least 3 months and at stable medium or high doses of ICS/LABA for at least 1 month
prior to Visit 1.

- Patients must be symptomatic at screening despite treatment with mid or high stable
doses of ICS/LABA. Patients with ACQ-7 score = 1.5 at Visit 101 and at Visit 102
(before randomization).

- Patients with documented history of at least one asthma exacerbation which required
medical care from a physician, ER visit (or local equivalent structure) or
hospitalization in the 12 months prior to Visit 1, and required systemic
corticosteroid treatment.

- Pre-bronchodilator FEV1 of < 80 % of the predicted normal value for the patient
according to ATS/ERS guidelines after withholding bronchodilators at both visits 101
and 102.

- Withholding period of bronchodilators prior to spirometry: SABA for = 6 hrs, Twice
daily LABA (or FDC of ICS/LABA) for = 12 hrs, Once daily LABA (or FDC of ICS/LABA) for
= 24 hrs, SAMA for = 8 hrs, Short acting xanthines for 12 hrs, Long acting xanthines
for 24 hrs, .

- Washout period of each drug should be kept as close as possible as above and should
not be longer. If longer washout period is needed due to scheduling issues, please
contact Novartis Medical monitor.

- A one-time repeat of percentage predicated FEV1 (Pre-bronchodilator) at Visit 101
and/or Visit 102 is allowed in an ad-hoc visit. Repeat of Visit 101 spirometry should
be done in an ad-hoc visit to be scheduled on a date that would provide sufficient
time to receive confirmation from the spirometry data central reviewer of the validity
of the assessment before randomization. Run-in medication should be dispensed once
spirometry assessment met inclusion criteria (ATS/ERS quality criteria, FEV1 %
predicted normal value, and reversibility) as per equipment

- A one-time rescreen is allowed in case the patient fails to meet the criteria at the
repeat, provided the patient returned to the required treatment as per inclusion
criteria 4

- 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 then one of the following criteria need to be met.

- 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 1.

- 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. If
reversibility is not demonstrated at Visit 101 (or after repeated assessment in an
ad-hoc visit) and historical evidence of reversibility/bronchoprovocation is not
available (or was not performed according to the ATS/ERS guidelines patients must be
screen failed

- Spacer devices are permitted during reversibility testing only. The Investigator or
delegate may decide whether or not to use a spacer for the reversibility testing

Exclusion Criteria:

- Patients who have had an asthma attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening). If
patients experience an asthma attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit between Visit 1 and Visit 102 they may be
re-screened 6 weeks after recovery from the exacerbation.

- Patients who have ever required intubation for a severe asthma attack/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 treated with a LAMA for asthma within 3 months prior Visit 1 (Screening).

- Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or
bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients
who are stable on treatment can be considered).

- Patients who have had a respiratory tract infection or asthma worsening as determined
by investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and
Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory
tract infection or asthma worsening.

- Patients with evidence upon visual inspection (laboratory culture is not required) of
clinically significant (in the opinion of investigator) oropharyngeal candidiasis at
Visit 102 or earlier, with or without treatment. Patients may be re-screened once
their candidiasis has been treated and has resolved.

- Patients with any chronic conditions affecting the upper respiratory tract (e.g.
chronic sinusitis) which in the opinion of the investigator may interfere with the
study evaluation or optimal participation in the study.

- Patients with a history of chronic lung diseases other than asthma, including (but not
limited to) chronic obstructive pulmonary disease, sarcoidosis, interstitial lung
disease, cystic fibrosis, clinically significant bronchiectasis and active
tuberculosis.

- Patients with Type I diabetes or uncontrolled Type II diabetes.

- Patients who, either in the judgment of the investigator or the responsible Novartis
personnel, have a clinically significant condition such as (but not limited to)
unstable ischemic heart disease, New York Heart Association (NYHA) Class III/IV left
ventricular failure arrhythmia, uncontrolled hypertension, cerebrovascular disease,
psychiatric disease, neurodegenerative diseases, or other neurological disease,
uncontrolled hypo- and hyperthyroidism and other autoimmune diseases, hypokalemia,
hyperadrenergic state, or ophthalmologic disorder or patients with a medical condition
that might compromise patient safety or compliance, interfere with evaluation, or
preclude completion of the study.

- Patients with paroxysmal (e.g., intermittent) atrial fibrillation are excluded.
Patients with persistent atrial fibrillation as defined by continuous atrial
fibrillation for at least 6 months a

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02571777

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02571777

Further information on trial

Date trial registered

05.10.2015

Incorporation of the first participant

01.02.2015

Recruitment status

Recruiting

Academic title (Source of data: WHO)

A Multicenter, Randomized, 52-week, Double-blind, Parallelgroup, Active Controlled Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Phase (Source of data: WHO)

Phase 3

Primary end point (Source of data: WHO)

Trough FEV1

Secundary end point (Source of data: WHO)

FEV1 at week 4 and week 12;Adverse events, vital signs, laboratory analysis and ECG;Serious asthma outcome incidence and CCV events/atrial fibrilaltion;Asthma control as assessed by the Asthma Control Questionnaire (ACQ-7) comparison with salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler®;Trough FEV1 at 26 weeks comparison with salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler®;AQLQ;% rescue medication free days over 26 and 52 weeks;asthma exacerbation over 52 weeks;% patients with MID ACQ>= 0,5 at week 26 and 52;% days without rescue medication use over 26 and 52 weeks;% days with no symptoms (overall, at awakening and rising);ACQ-7;PEF over 26 and 52 weeks;FVC at week 4 and week 12

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Basel, Liestal, St Gallen

Countries (Source of data: WHO)

Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Vietnam

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Dr. Moritz Jacobshagen
+41 79 750 29 53
moritz.jacobshagen@novartis.com

Contact for general information (Source of data: WHO)

Novartis Pharmaceuticals
+41613241111

Contact for scientific information (Source of data: WHO)

Novartis Pharmaceuticals
+41613241111

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Novartis Pharmaceuticals

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2016-00113

Secondary ID (Source of data: WHO)

CQVM149B2302