Clinical Trials Register

Summary
EudraCT Number:	2013-001477-25
Sponsor's Protocol Code Number:	CQVA149ADE03
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-10-22
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

Germany - BfArM

A.2

EudraCT number

2013-001477-25

A.3

Full title of the trial

A randomized, double-blind, placebo-controlled, multicenter cross-over study to assess the effects of a 3 week therapy each with QVA149 versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

A.3.1

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

Study to assess the effects of a 3 week therapy each with QVA149 versus placebo on pulmonary function and average physical activity levels in patients with moderate to severe COPD

A.3.2

Name or abbreviated title of the trial where available

MOVE

A.4.1

Sponsor's protocol code number

CQVA149ADE03

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 Pharma GmbH
B.1.3.4	Country	Germany
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 GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Pharma GmbH
B.5.2	Functional name of contact point	Medizinischer Infoservice
B.5.3	Address:
B.5.3.1	Street Address	Roonstr. 25
B.5.3.2	Town/ city	Nürnberg
B.5.3.3	Post code	90429
B.5.3.4	Country	Germany
B.5.4	Telephone number	+491802232300
B.5.5	Fax number	+4991127312160
B.5.6	E-mail	infoservice.novartis@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	QVA149
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.3.9.1	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	110
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.3.9.4	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	50
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

chronic obstructive pulmonary disease (COPD)

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	17.0
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

Primary objective:
 To demonstrate that QVA149 (110/50 μg q.d.) is superior compared to placebo on peak inspiratory capacity (IC) after 21 days of treatment in patients with moderate to severe COPD.

Co-primary objective:
 To evaluate whether QVA149 is superior to placebo with respect to average physical activity level as defined by average daily activity-related energy consumption [Kcal/day].

E.2.2

Secondary objectives of the trial

 To evaluate the effects QVA149 compared to placebo on the average number of steps per day
 To evaluate the effects QVA149 compared to placebo on the duration of at least moderate activity per day
 To demonstrate that QVA149 (110/50 μg o.d.) is superior compared to placebo on peak IC on day 1
 To demonstrate that QVA149 (110/50 μg o.d.) is superior compared to placebo on trough IC after 21 days of treatment
 To demonstrate that QVA149 (110/50 μg o.d.) is superior compared to placebo on peak FEV1 on day 1
 To demonstrate that QVA149 (110/50 μg o.d.) is superior compared to placebo on trough FEV1 after 21 days of treatment

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male and female adults aged ≥40 years.
2. Patients who have signed an Informed Consent Form prior to initiation of any study-related procedure.
3. Patients with stable COPD according to the current GOLD guidelines (GOLD 2013).
4. Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 yrs, or ½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who has not smoked for ≥ 6 months at screening.
5. Patients with airflow limitation indicated by a post-bronchodilator FEV1 ≥40% and <80% of the predicted normal, and a post-bronchodilator FEV1/FVC <0.70 at Visit 2.

E.4

Principal exclusion criteria

1. Patients with conditions contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof
 anticholinergics
 long and short acting beta2 agonists
 sympathomimetic amines
 lactose or any of the other excipients
2. Patients with a history of long QT syndrome or whose QTc calculated at run-in (Fredericia method) is prolonged (>450ms for males and >470ms for females).These patients should not be re-enrolled.
3. Patients who have a clinically significant ECG abnormality at Visit 1, who in the judgment of the investigator would be at potential risk if enrolled into the study. These patients should not be re-screened.
4. 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 and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at baseline and screening visits, with a resting ventricular rate < 100/min.
5. Patients with Type I or uncontrolled Type II diabetes and patients with a history of blood glucose levels consistently outside the normal range or HbA1c> 8.0% at Visit 2.
6. Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50ml/min/1,73² at visit 1) or urinary retention. (Patients with a transurethral resection of prostate (TURP) are excluded from the study. Patients who have undergone full resection of the prostate may be considered for the study, as well as patients who are asymptomatic and stable on pharmacological treatment for the condition).
7. Patients with a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with non-melanoma skin carcinoma may be considered for the study.
8. Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic or haemotological abnormalities which could interfere with the assessment of the efficacy and safety of the study.
9. Patients who are, in the opinion of the investigator known to be unreliable or non- compliant.
10. Patients with a body mass index (BMI) of more than 40 kg/m2.
11. Patients, who have already been randomized into this trial earlier must not be included a second time.
12. Study personnel or first degree relatives of investigator(s) must not be included in the study.
13. Patients incapable of giving full informed consent.
14. Patients who have not achieved acceptable spirometry results at run-in in accordance with
ATS/ERS criteria for acceptability and repeatability.
15. Women who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive beta-hCG laboratory test (> 5 mIU/ml)).
16. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception (Pearl Index <1*) during the study and up to at least 4 weeks after the end of treatment. UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea OR 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m OR 6 weeks after surgical bilateral oophorectomy (with or without hysterectomy). * Examples of particularly reliable methods with Pearl Index (PI) <1, according to guidelines of Deutsche Gesellschaft für Gynäkologie und Geburtshilfe:
 Combination pill with estrogen and gestagen (no mini-pill, PI=0.1-0.9)
 Vaginal ring (NuvaRing®, PI=0.65 uncorr.; 0.4 corr.)
 Contraceptive patch (EVRA®, PI= 0.72 uncorr.; 0.9 corr.)
 Estrogen-free ovulation inhibitors (Cerazette®, PI=0.14)
 Progestin-containing contraceptives (Implanon®, PI=0-0.08)
 Intra-uterine progestine device (Mirena®, PI=0.16)
Oral contraceptives without estrogen (e.g. "mini-pills"), nonsynthetic progesterone only IUDs, female condoms, cervical shield, periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Fertile males, defined as all males physiologically capable of conceiving offspring UNLESS the patient and his partner agree to comply with acceptable contraception, including a combination of male condom and spermicidal gel.

E.5 End points

E.5.1

Primary end point(s)

To demonstrate that QVA149 (110/50 μg q.d.) is superior compared to placebo on peak inspiratory capacity (IC) after 21 days of treatment in patients with moderate to severe COPD.

To evaluate whether QVA149 is superior to placebo with respect to average physical activity level as defined by average daily activity-related energy consumption [Kcal/day].

E.5.1.1

Timepoint(s) of evaluation of this end point

8 to 10 weeks

E.5.2

Secondary end point(s)

To evaluate the effects QVA149 compared to placebo on the average number of steps per day
 To evaluate the effects QVA149 compared to placebo on the duration of at least moderate activity per day
 To demonstrate that QVA149 (110/50 μg o.d.) is superior compared to placebo on peak IC on day 1
 To demonstrate that QVA149 (110/50 μg o.d.) is superior compared to placebo on trough IC after 21 days of treatment
 To demonstrate that QVA149 (110/50 μg o.d.) is superior compared to placebo on peak FEV1 on day 1
 To demonstrate that QVA149 (110/50 μg o.d.) is superior compared to placebo on trough FEV1 after 21 days of treatment

E.5.2.1

Timepoint(s) of evaluation of this end point

8 to 10 weeks

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

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

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Change in physical activity

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

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

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

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

LPLV

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	70
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	120
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	190

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

2013-11-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-02-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-02-11

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