Chronic Obstructive Pulmonary Disease Clinical Trial
— FASTOfficial title:
A Randomized, Double-blind, Multicenter, 2-period Single-dose Cross-over Study to Assess the Early Bronchodilation of Glycopyrronium Bromide (44 μg o.d.) Compared to Tiotropium (18 µg. o.d.) in Patients With Moderate to Severe COPD (FAST Study)
Verified date | December 2014 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.
Status | Completed |
Enrollment | 152 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Male or female adults aged =40 years - Patients with moderate to severe COPD defined by a post-bronchodilator Forced Expiratory Volume in One Second (FEV1)/(FVC) Forced Vital Capacity ratio of <0.70 and a post-bronchodilator FEV1 of =70% and FEV1 = 30% of predicted normal values. - Current or ex-smokers who have a smoking history of at least 10 pack years. Exclusion Criteria: - Pregnant or nursing (lactating) women - Patients who have a clinically significant laboratory abnormality at run-in - Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment (GFR <50 ml/min/1,732) or urinary retention. (BPH patients who are stable on treatment can be considered). - Patients with any history of asthma - Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation - Patients receiving medications in the classes listed in the protocol as prohibited. Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Frankfurt | |
Germany | Novartis Investigative Site | Gelsenkirchen | |
Germany | Novartis Investigative Site | Grosshansdorf | |
Germany | Novartis Investigative Site | Gummersbach | |
Germany | Novartis Investigative Site | Hamburg | |
Germany | Novartis Investigative Site | Kassel | |
Germany | Novartis Investigative Site | Leipzig | |
Germany | Novartis Investigative Site | Lübeck | |
Germany | Novartis Investigative Site | Rüdersdorf | |
Germany | Novartis Investigative Site | Sonneberg |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2 | Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h). | Day 1 | No |
Secondary | Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose | Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. | Day 1 | No |
Secondary | Specific Airway Resistance (sRAW) | Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw. | Day 1 | No |
Secondary | Functional Resistance Capacity (FRCpleth) | Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox). | Day 1 | No |
Secondary | Residual Volume (RV) | Residual Volume (RV) will be measured using whole body plethysmography (Bodybox). | Day 1 | No |
Secondary | Total Lung Capacity (TLC) | Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC. | Day 1 | No |
Secondary | Inspiratory Capacity (IC) | Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC. | Day 1 | No |
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