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

Study Description

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Brief Summary:

The study purpose is to evaluate the effect of QAB149

• NVA237 vs. QAB149 on static lung hyperinflation.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease: COPD	Drug: QAB149; Drug: Placebo; Drug: NVA237	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	79 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, 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.
Study Start Date :	November 2012
Actual Primary Completion Date :	June 2014
Actual Study Completion Date :	June 2014

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 ]
   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 :

1. 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 ]
   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
2. Inspiratory Capacity (IC) [ Time Frame: within 4h after dosing ]
   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
3. 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 ]
   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
4. 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 ]
   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
5. Airway Resistance (Raw) [ Time Frame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours ]
   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

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Salomon J, Stolz D, Domenighetti G, Frey JG, Turk AJ, Azzola A, Sigrist T, Fitting JW, Schmidt U, Geiser T, Wild C, Kostikas K, Clemens A, Brutsche M. Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled study. Respir Res. 2017 Jan 11;18(1):13. doi: 10.1186/s12931-016-0498-1.

Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01699685 History of Changes
Other Study ID Numbers:	CNVA237ACH01; 2012-002362-13 ( EudraCT Number )
First Posted:	October 4, 2012
Results First Posted:	February 9, 2016
Last Update Posted:	February 9, 2016
Last Verified:	January 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

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; Lactitol; Glycopyrrolate; Cathartics; Gastrointestinal Agents	Adjuvants, Anesthesia; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs