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

• Register: EUCTR
• Last refreshed on: 9 March 2015
• Main ID: EUCTR2013-001477-25-DE
• Date of registration: 22/10/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma GmbH
• Public title: 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
• Scientific title: 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) - MOVE
• Date of first enrolment: 18/02/2014
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001477-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany

Contacts

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
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 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

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 capab

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

chronic obstructive pulmonary disease (COPD)
MedDRA version: 17.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Product Name: QVA149
Product Code: QVA149
Pharmaceutical Form: Inhalation powder, hard capsule
CAS Number: 753498-25-8
Current Sponsor code: QAB149
Other descriptive name: INDACATEROL MALEATE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 110-
INN or Proposed INN: GLYCOPYRRONIUM BROMIDE
CAS Number: 596-51-0
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Inhalation powder, hard capsule
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

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].

Secondary Objective: ? 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

Main Objective: 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].

Timepoint(s) of evaluation of this end point: 8 to 10 weeks

Secondary Outcome(s)

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

Timepoint(s) of evaluation of this end point: 8 to 10 weeks

Secondary ID(s)

CQVA149ADE03

Source(s) of Monetary Support

Novartis Pharma GmbH