Clinical Trials Register

Summary
EudraCT Number:	2013-005573-51
Sponsor's Protocol Code Number:	CQVA149ANO01
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2014-07-08
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

Sweden - MPA

A.2

EudraCT number

2013-005573-51

A.3

Full title of the trial

A 12-week, multicenter, cross-over, placebo-controlled, double-blind study to determine the impact of QVA149 (indacaterol/glycopyrronium) 85/43 µg on nocturnal oxygen levels in Chronic Obstructive Pulmonary Disease (COPD).

A.3.1

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

A study to determine the impact QVA149 (indacaterol/glycopyrronium) 85/43 µg has on nocturnal oxygen levels in Chronic Obstructive Pulmonary Disease (COPD).

A.3.2

Name or abbreviated title of the trial where available

DuoSleep

A.4.1

Sponsor's protocol code number

CQVA149ANO01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Sverige AB
B.1.3.4	Country	Sweden
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 Sverige AB
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Sverige AB
B.5.2	Functional name of contact point	Medicinsk Information
B.5.3	Address:
B.5.3.1	Street Address	Box 1150
B.5.3.2	Town/ city	Täby
B.5.3.3	Post code	183 11
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+468732 32 00
B.5.5	Fax number	+468732 32 01
B.5.6	E-mail	medinfo.se@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	Yes
D.2.1.1.1	Trade name	Ultibro Breezhaler
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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 maleate/Glycopyrronium bromide
D.3.2	Product code	QVA149
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	GLYCOPYRRONIUM BROMIDE
D.3.9.1	CAS number	596-51-0
D.3.9.2	Current sponsor code	NVA237
D.3.9.4	EV Substance Code	SUB07951MIG
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	43
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Indacaterol maleate
D.3.9.1	CAS number	753498-25-8
D.3.9.2	Current sponsor code	QAB149
D.3.9.3	Other descriptive name	INDACATEROL MALEATE
D.3.9.4	EV Substance Code	SUB30300
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	85
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Obstructive Pulmonary Disease (COPD)

E.1.1.1

Medical condition in easily understood language

COPD is a chronic condition of the lungs which causes people to suffer symptoms such as shortness of breath and coughing.

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	LLT
E.1.2	Classification code	10010952
E.1.2	Term	COPD
E.1.2	System Organ Class	100000004855

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine the impact of the fixed dose combination of indacaterol and glycopyrronium on mean nighttime oxygen hemoglobin saturation (SpO2) in patients with COPD.

E.2.2

Secondary objectives of the trial

Secondary objective
- To assess the time spent below 90% in SpO2 following 4 week`s administration of QVA149 compared to placebo

Explorative objectives:
- To assess the effect of QVA149 versus placebo on the number of awakenings and wake-up time
- To assess lung function and lung volumes following 4 week´s administration of QVA149 compared to placebo by body box measured in the morning prior to drug administration
- To assess the effect of QVA149 versus placebo on sleep quality (Medical Outcomes Study Scale-Sleep (MOS-sleep) and COPD and Asthma Sleep Impact Scale (CASIS) questionnaires)
- To assess the effect of QVA149 versus placebo on the level of COPD symptoms assessed by COPD assessment test (CAT) questionnaire (0-40, Minimal Clinical Important Difference (MCID)≥2)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed
2. Male or female adults aged ≥40 years
3. Resting daytime oxygen saturation levels measured by pulse oximetry of ≤95% SpaO2
4. Patients with a post-bronchodilator FEV1 ≥30% and <60% of the predicted normal value
5. Clinical diagnosis of COPD (according to GOLD guidelines, updated 2014)1 with a pPostbronchodilator
FEV1/Forced vital capacity (FVC) FEV1/FVC <0.70
6. Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack-years are
defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years)

E.4

Principal exclusion criteria

Patients fulfilling any of the following criteria are not eligible for
inclusion in this study.
1. Women of childbearing potential not using contraception method(s),
as well as women who are breastfeeding
2. Ongoing / planned rehabilitation during the study period
3. An exacerbation of COPD (treatment with oral or parenteral
antibiotics and/or glucocorticosteroids and/or hospitalization related to
COPD) within 4 weeks prior to screening or during the run-in period
4. Use of oral or systemic glucocorticosteroids within 4 weeks prior to
screening or during the run-in period
5. 3 or more awakenings during the night leading to toilet visit or other
reasons for exiting the bed during the last week prior to the screening
visit due to non-COPD reasons (morning toilet visit not included)
6. Respiratory tract infection in the 4 weeks prior to screening or during
the run-in period
7. Body Mass Index (BMI) >32
8. Diagnosed asthma
9. Malignancy of any organ system (except localized basal cell carcinoma
of the skin)
10. Diabetes mellitus requiring insulin
11. Long QT syndrome or QTc>450 ms (males) or 470 ms (females)
12. Severe renal impairment (GFR: ≤30 ml/min/1.73 m2)
13. Patients receiving regular long term oxygen therapy (LTOT)
14. Known sleep apnea (≥15 apneas or hypopneas per hour of sleep) or
who have or have had previous Bilevel Positive Airway Pressure (BIPAP)
or Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea
15. Symptomatic urinary outflow obstruction
16. Shift workers (or other external conditions affecting sleep and sleep
quality on a regular basis)
17. Narrow-angle glaucoma
18. Hypersensitivity to any of the ingredients of the investigational
therapy
19. Unstable (based upon the investigator evaluation) cardiovascular
disease
20. Use of non-selective beta-blockers, including eye-drops (Cautious
use of cardioselective beta-blocking agents is allowed at the discretion
of the investigator)
21. Use of anticholinergic medications (except from study treatment)

E.5 End points

E.5.1

Primary end point(s)

Mean night-time oxygen hemoglobin saturation level

E.5.1.1

Timepoint(s) of evaluation of this end point

Timeframe: 28 days

E.5.2

Secondary end point(s)

-Time spent below 90% in SaO2
-Number of awakenings and wake-up time
-Lung function and lung volumes by body box measured in the morning prior to drug administration
-Sleep quality (Medical Outcomes Study Scale-Sleep (MOS-sleep) and COPD and Asthma Sleep Impact Scale (CASIS) questionnaires)
-Level of COPD symptoms assessed by COPD assessment test (CAT) questionnaire (0-40, Minimal Clinical Important Difference (MCID)≥2)

E.5.2.1

Timepoint(s) of evaluation of this end point

Timeframe: 28 days

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

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

E.8.1.6

Cross over

Yes

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

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

Yes

E.8.4

The trial involves multiple sites in the 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

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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 years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

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

F.4.2.2

In the whole clinical trial

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

2014-07-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-07-16

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-06-22

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