Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide. (SYNERGY)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease: COPD

Treatments: Drug: QAB149; Drug: Placebo; Drug: NVA237

Study type: Interventional

Funder types: Industry

Identifiers

NCT01699685

2012-002362-13 (EudraCT Number)

CNVA237ACH01

Details and patient eligibility

About

The study purpose is to evaluate the effect of QAB149

• NVA237 vs. QAB149 on static lung hyperinflation.

Full description

This is a multicenter, randomized, double-blinded, single-dose, cross-over, placebo-controlled study. The primary endpoint was chosen to demonstrate the superiority of a single-dose of the combined inhalation vs. the mono inhalation regarding the Inspiratory Capacity (IC) peak value. A total of 78 patients will be randomized to complete two visits with two single doses of treatment. Patients will be randomized in a cross-over manner. Treatment visits will be separated by a study medication wash-out period.Treatments will be administered in a blinded fashion.

The patients will be male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >10-pack years history of smoking, FEV1 <80% and ≥30% of the predicted normal value.

Enrollment: 79 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria and >10-pack year history of smoking
• FEV1 <80% and ≥30% of the predicted normal value who have signed an informed consent form prior to the initiation of any study-related procedure

Exclusion criteria

• No COPD exacerbations within 6 weeks prior to dosing
• No concomitant lung disease such as asthma
• Nno requirement for long term oxygen treatment or history of lung reduction surgery
• No medical conditions that would interfere with the performance of spirometry
• No other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk form being in the study e.g. uncontrolled hypertension or unstable ischemic heart disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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79 participants in 2 patient groups, including a placebo group

Sequence A

Placebo Comparator group

Description:

Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI

Treatment:

Drug: Placebo

Drug: QAB149

Sequence B

Active Comparator group

Description:

Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI

Treatment:

Drug: NVA237

Drug: QAB149