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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

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The study purpose is to evaluate the effect of QAB149

* NVA237 vs. QAB149 on static lung hyperinflation.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease: COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Interventions

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NVA237

Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Intervention Type DRUG

QAB149

Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Intervention Type DRUG

Placebo

Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No