Clinical Trials Register

Summary
EudraCT Number:	2016-000472-22
Sponsor's Protocol Code Number:	CQVM149B2303
National Competent Authority:	Lithuania - SMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-01-23
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Lithuania - SMCA

A.2

EudraCT number

2016-000472-22

A.3

Full title of the trial

A multi-center, randomized, 12-week treatment, double-blind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma

Daugiacentris, atsitiktinių imčių, 12 savaičių tiriamojo vaistinio preparato vartojimo, dvigubai koduotas tyrimas QMF149 (150 / 80 mikrogramų) veiksmingumui ir saugumui įvertinti, lyginant su MF Twisthaler® (200 mikrogramų), skiriant astma sergantiems suaugusiesiems ir paaugliams

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Efficacy and safety of low dose QMF149 (150/80 microgram) compared with MF Twisthaler® in patients with asthma

A.3.2

Name or abbreviated title of the trial where available

n/a

A.4.1

Sponsor's protocol code number

CQVM149B2303

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/057/2018

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Pharma Services AG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novartis Pharma Services AG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SIA Novartis Baltics Lithuanian Branch
B.5.2	Functional name of contact point	Clinical Trial Information Desk
B.5.3	Address:
B.5.3.1	Street Address	Konstitucijos pr. 7
B.5.3.2	Town/ city	Vilnius
B.5.3.3	Post code	LT-09308
B.5.3.4	Country	Lithuania
B.5.4	Telephone number	+370 5 269 1650
B.5.5	Fax number	+370 5 249 6338
B.5.6	E-mail	DRA.Lithuania@novartis.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Indacaterol acetate / mometasone furoate
D.3.2	Product code	QMF149
D.3.4	Pharmaceutical form	Inhalation powder, hard capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INDACATEROL ACETATE
D.3.9.3	Other descriptive name	INDACATEROL ACETATE
D.3.9.4	EV Substance Code	SUB32071
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MOMETASONE FUROATE
D.3.9.3	Other descriptive name	MOMETASONE FUROATE
D.3.9.4	EV Substance Code	SUB03318MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Asmanex Twisthaler
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Inhalation powder
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MOMETASONE FUROATE
D.3.9.3	Other descriptive name	MOMETASONE FUROATE
D.3.9.4	EV Substance Code	SUB03318MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation powder, hard capsule
D.8.4	Route of administration of the placebo	Inhalation use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation powder
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Asthma

E.1.1.1

Medical condition in easily understood language

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

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

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

week 12

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

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

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

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

LVLS

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

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

665

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

The younger children recruited in this trial may lack understandment of what a clinical trial is and its purpose, so their parents/guardians will give consent on their behalf

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

410

F.4.2.2

In the whole clinical trial

750

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-03-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-19

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-11-30

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