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

NCT01699685 | Completed Phase 3 Results

• 2 other identifiers: CNVA237ACH012012-002362-13
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 11

Brief Summary

The study purpose is to evaluate the effect of QAB149

• NVA237 vs. QAB149 on static lung hyperinflation.

Conditions

Chronic Obstructive Pulmonary Disease: COPD

Keywords

Moderate to severe COPD patients are included; NVA; QAB

Outcome Measures

Primary Outcomes (1)

• 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).

  Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

Secondary Outcomes (5)

• Forced Expiratory Volume in One Second (FEV1)

  Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

• Inspiratory Capacity (IC)

  within 4h after dosing

• Forced Volume Capacity (FVC)

  Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

• Total Lung Capacity (TLC)

  Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

• Airway Resistance (Raw)

  Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours

Study Arms (2)

Sequence A

PLACEBO COMPARATOR

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

Drug: QAB149; Drug: Placebo

Sequence B

ACTIVE COMPARATOR

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

Drug: QAB149; Drug: NVA237

Interventions

QAB149 DRUG

Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Sequence A; Sequence B

Placebo DRUG

Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Sequence A

NVA237 DRUG

Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI

Sequence B

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Novartis Investigative Site

Faltigberg-Wald, Canton of Zurich, 8639, Switzerland

Location

Novartis Investigative Site

Basel, Switzerland, 4031, Switzerland

Location

Novartis Investigative Site

Locarno, Switzerland, 6600, Switzerland

Location

Novartis Investigative Site

Barmelweid, 5017, Switzerland

Location

Novartis Investigative Site

Bern, 3010, Switzerland

Location

Novartis Investigative Site

Bern, 3013, Switzerland

Location

Novartis Investigative Site

Crans-Montana, 3963, Switzerland

Location

Novartis Investigative Site

Lausanne, 1011, Switzerland

Location

Novartis Investigative Site

Lugano, 6900, Switzerland

Location

Novartis Investigative Site

Sankt Gallen, 9007, Switzerland

Location

Novartis Investigative Site

Walenstadtberg, 8881, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28077140 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

indacaterol; Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Corinne Wild, PhD

  Novartis Pharmaceuticals

  STUDY DIRECTOR

• Corinne Wild, PhD

  Novartis Pharmaceuticals

  STUDY CHAIR

• Martin Brutsche, Prof. Dr. med.

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 4, 2012
• Study Start: November 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 9, 2016
• Results First Posted: February 9, 2016

Record last verified: 2016-01

Locations

CH (11)