Chronic Obstructive Pulmonary Disease: COPD Clinical Trial
— SYNERGYOfficial 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.
| Verified date | January 2016 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Switzerland: Swissmedic |
| Study type | Interventional |
The study purpose is to evaluate the effect of QAB149
- NVA237 vs. QAB149 on static lung hyperinflation.
| Status | Completed |
| Enrollment | 79 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Novartis Investigative Site | Barmelweid | |
| Switzerland | Novartis Investigative Site | Basel | |
| Switzerland | Novartis Investigative Site | Bern | |
| Switzerland | Novartis Investigative Site | Bern | |
| Switzerland | Novartis Investigative Site | Crans-Montana | |
| Switzerland | Novartis Investigative Site | Faltigberg-Wald | ZH |
| Switzerland | Novartis Investigative Site | Lausanne | |
| Switzerland | Novartis Investigative Site | Locarno | |
| Switzerland | Novartis Investigative Site | Lugano | |
| Switzerland | Novartis Investigative Site | St. Gallen | |
| Switzerland | Novartis Investigative Site | Walenstadtberg |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours | No |
| Secondary | 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 | within 4h after dosing | No |
| Secondary | 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 | Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours | No |
| Secondary | 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 | Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours | No |
| Secondary | 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 | Day (0) 30minutes, 1, 2, 3, and 4 hours; Day (6) 30 minutes, 1, 2, 3, and 4 hours | No |