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

• ClinicalTrials.gov Identifier: NCT01699685
• Recruitment Status: Completed
• First Posted: October 4, 2012
• Results First Posted: February 9, 2016
• Last Update Posted: February 9, 2016
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Study Description

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

• 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

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

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

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• 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

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

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