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

Primary Purpose

Chronic Obstructive Pulmonary Disease: COPD

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
QAB149
Placebo
NVA237
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease: COPD focused on measuring Moderate to severe COPD patients are included, NVA, QAB

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sequence A

Sequence B

Arm Description

Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI

Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI

Outcomes

Primary Outcome Measures

Inspiratory Capacity (IC) Peak Value
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)
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)
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)
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)
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)
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

Full Information

First Posted
September 28, 2012
Last Updated
January 11, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01699685
Brief Title
Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.
Acronym
SYNERGY
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study purpose is to evaluate the effect of QAB149 NVA237 vs. QAB149 on static lung hyperinflation.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease: COPD
Keywords
Moderate to severe COPD patients are included, NVA, QAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A
Arm Type
Placebo Comparator
Arm Description
Patients will inhale QAB149 (capsule form in blister packs) + Placebo via Novartis Concept 1 SDDPI
Arm Title
Sequence B
Arm Type
Active Comparator
Arm Description
Patients will inhale QAB149 plus NVA237 (capsule form in blister packs) via Novartis Concept 1 SDDPI
Intervention Type
Drug
Intervention Name(s)
QAB149
Intervention Description
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
Intervention Type
Drug
Intervention Name(s)
NVA237
Intervention Description
Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
Primary Outcome Measure Information:
Title
Inspiratory Capacity (IC) Peak Value
Description
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).
Time Frame
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Secondary Outcome Measure Information:
Title
Forced Expiratory Volume in One Second (FEV1)
Description
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
Time Frame
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Title
Inspiratory Capacity (IC)
Description
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
Time Frame
within 4h after dosing
Title
Forced Volume Capacity (FVC)
Description
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
Time Frame
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Title
Total Lung Capacity (TLC)
Description
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
Time Frame
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Title
Airway Resistance (Raw)
Description
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
Time Frame
Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Wild, PhD
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Corinne Wild, PhD
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martin Brutsche, Prof. Dr. med.
Organizational Affiliation
Kantonsspital St. Gallen, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigative Site
City
Faltigberg-Wald
State/Province
ZH
ZIP/Postal Code
8639
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Barmelweid
ZIP/Postal Code
5017
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3013
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Crans-Montana
ZIP/Postal Code
3963
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Locarno
ZIP/Postal Code
6600
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Novartis Investigative Site
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Walenstadtberg
ZIP/Postal Code
8881
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28077140
Citation
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.
Results Reference
derived

Learn more about this trial

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

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