Clinical trial NCT01699685: Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease: COPD
Keywords: Moderate to severe COPD patients are included
NVA
QAB
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-10-04
Enrollment: 79
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Inspiratory Capacity (IC) Peak Value
timeFrame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Secondary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
measure: Inspiratory Capacity (IC)
timeFrame: within 4h after dosing
measure: Forced Volume Capacity (FVC)
timeFrame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
measure: Total Lung Capacity (TLC)
timeFrame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
measure: Airway Resistance (Raw)
timeFrame: Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours
Other outcomes:
Locations:
city: Faltigberg-Wald
country: Switzerland
facility: Novartis Investigative Site
state: ZH
city: Barmelweid
country: Switzerland
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Crans-Montana
country: Switzerland
facility: Novartis Investigative Site
city: Lausanne
country: Switzerland
facility: Novartis Investigative Site
city: Locarno
country: Switzerland
facility: Novartis Investigative Site
city: Lugano
country: Switzerland
facility: Novartis Investigative Site
city: St. Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Walenstadtberg
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Corinne Wild, PhD
role: STUDY_DIRECTOR
affiliation: Novartis Pharmaceuticals
name: Corinne Wild, PhD
role: STUDY_CHAIR
affiliation: Kantonsspital St. Gallen, Switzerland
name: Martin Brutsche, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
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.