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:

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: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ] [ Designated as safety issue: No ]
IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean at one of the post-dose measurements (30min, 60min, 120min, 180min and 240min).

Secondary Outcome Measures:

Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ] [ Designated as safety issue: No ]
FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was at 30, 60, 120, 180, and 240 minutes post-dose. Spirometry equipment and performance of spirometric testing had to be in accordance with standards as outlined in the American Thoracic Society for the Standardization of Spirometry recommendations. The spirometry equipment used during the study had to meet or exceed these minimal ATS recommendations
Inspiratory Capacity (IC) [ Time Frame: within 4h after dosing ] [ Designated as safety issue: No ]
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured at 30, 60, 120, 180, and 240 minutes post-dose
Forced Volume Capacity (FVC) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ] [ Designated as safety issue: No ]
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time
Total Lung Capacity (TLC) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ] [ Designated as safety issue: No ]
TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30, 60, 120, 180 and 240 minutes post dose
Airway Resistance (Raw) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ] [ Designated as safety issue: No ]
Raw was measured with spirometry conducted according to internationally accepted standards. Raw was the mean of the measurements which were measured each at 30, 60, 120, 180 and 240 minutes


Enrollment:	79
Study Start Date:	November 2012
Study Completion Date:	June 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Sequence A 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: Sequence B 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Switzerland
Novartis Investigative Site
Faltigberg-Wald, ZH, Switzerland, 8639
Novartis Investigative Site
Barmelweid, Switzerland, 5017
Novartis Investigative Site
Basel, Switzerland, 4031
Novartis Investigative Site
Bern, Switzerland, 3010
Novartis Investigative Site
Bern, Switzerland, 3013
Novartis Investigative Site
Crans-Montana, Switzerland, 3963
Novartis Investigative Site
Lausanne, Switzerland, 1011
Novartis Investigative Site
Locarno, Switzerland, 6600
Novartis Investigative Site
Lugano, Switzerland, 6900
Novartis Investigative Site
St. Gallen, Switzerland, 9007
Novartis Investigative Site
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


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01699685 History of Changes
Other Study ID Numbers:	CNVA237ACH01 2012-002362-13
Study First Received:	September 28, 2012
Results First Received:	June 26, 2015
Last Updated:	January 11, 2016
Health Authority:	Switzerland: Swissmedic

Keywords provided by Novartis:


Moderate to severe COPD patients are included NVA QAB

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Glycopyrrolate Adjuvants, Anesthesia	Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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