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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01699685
First received: September 28, 2012
Last updated: May 21, 2014
Last verified: May 2014
  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:


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: July 2014
Estimated Primary Completion Date: July 2014 (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
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

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
Genève, Switzerland, 1211
Novartis Investigative Site Completed
Heiligenschwendi, Switzerland, 3625
Novartis Investigative Site Recruiting
Lausanne, Switzerland, 1011
Novartis Investigative Site Recruiting
Locarno, Switzerland, 6600
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: May 21, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by Novartis:
Moderate to severe COPD patients are included
NVA
QAB

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014