Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide. - Full Text View

Purpose

The study purpose is to evaluate the effect of QAB149

NVA237 vs. QAB149 on static lung hyperinflation.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease: COPD	Drug: QAB149 Drug: Placebo Drug: NVA237	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Single-dose Study to Assess the Effect of the QAB149 and NVA237 Combination Versus QAB149 Alone on Inspiratory Capacity in Patients With Moderate or Severe COPD.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Indacaterol

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Inspiratory Capacity (IC) peak value [ Time Frame: maximum value within 4h after inhalation ] [ Designated as safety issue: No ]
To demonstrate superiority of a single-dose of the combined inhalation of QAB149 and NVA237 vs. QAB149 alone regarding the Inspiratory Capacity (IC) peak value (defined as maximum value within 4h after inhalation).

Secondary Outcome Measures:

Forced Expiratory Volume in one second (FEV1) [ Time Frame: within 4h after dosing ] [ Designated as safety issue: No ]
Key Secondary Objective: • To compare the efficacy of the combined inhalation of QAB149 and NVA237 vs. QAB149 alone regarding FEV1 over 4h.
Inspiratory Capacity (IC) [ Time Frame: within 4h after dosing ] [ Designated as safety issue: No ]
To compare the efficacy of the combined inhalation of QAB149 and NVA237 vs. QAB149 alone regarding the Inspiratory Capacity (IC) over 4h.
Forced Volume Capacity (FVC) [ Time Frame: within 4h after dosing ] [ Designated as safety issue: No ]
To compare the efficacy of the combined inhalation of QAB149 and NVA237 vs. QAB149 alone regarding Forced Volume Capacity (FVC) over 4h.
Total Lung Capacity (TLC) [ Time Frame: within 4h after dosing ] [ Designated as safety issue: No ]
To compare the efficacy of the combined inhalation of QAB149 and NVA237 vs. QAB149 alone regarding of Total Lung Capacity (TLC) over 4h.
Airway Resistance (Raw) [ Time Frame: within 4h after dosing ] [ Designated as safety issue: No ]
To compare the efficacy of the combined inhalation of QAB149 and NVA237 vs. QAB149 alone regarding Airway Resistance (Raw) over 4h.

Estimated Enrollment:	78
Study Start Date:	November 2012
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: QAB149 + Placebo Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI	Drug: QAB149 Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI Drug: Placebo Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
Active Comparator: QAB149 + NVA237 Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI	Drug: QAB149 Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI Drug: NVA237 Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Detailed 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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699685

Contacts

Contact: Novartis Pharmaceuticals, PhD	+41613241111	corinne.wild@novartis.com
Contact: Novartis Pharmaceuticals, Dr. med.	+41 31 377 53 62	Stephanie.Juritz@novartis.com

Locations

Switzerland
Novartis Investigative Site	Recruiting
Faltigberg-Wald, ZH, Switzerland, 8639
Novartis Investigative Site	Recruiting
Barmelweid, Switzerland, 5017
Novartis Investigative Site	Recruiting
Basel, Switzerland, 4031
Novartis Investigative Site	Recruiting
Bern, Switzerland, 3010
Novartis Investigative Site	Recruiting
Bern, Switzerland, 3013
Novartis Investigative Site	Recruiting
Crans-Montana, Switzerland, 3963
Novartis Investigative Site	Recruiting
Heiligenschwendi, Switzerland, 3625
Novartis Investigative Site	Recruiting
Lausanne, Switzerland, 1011
Novartis Investigative Site	Recruiting
Lugano, Switzerland, 6900
Novartis Investigative Site	Recruiting
St. Gallen, Switzerland, 9007
Novartis Investigative Site	Recruiting
Walenstadtberg, Switzerland, 8881

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:	Corinne Wild, PhD	Novartis Pharmaceuticals
Study Chair:	Corinne Wild, PhD	Novartis Pharmaceuticals
Principal Investigator:	Martin Brutsche, Prof. Dr. med.	Kantonsspital St. Gallen, Switzerland

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01699685 History of Changes
Other Study ID Numbers:	CNVA237ACH01, 2012-002362-13
Study First Received:	September 28, 2012
Last Updated:	March 27, 2013
Health Authority:	Switzerland: Swissmedic

Keywords provided by Novartis:

Moderate to severe COPD patients are included
NVA
QAB

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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