Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

— FAST  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922271
• Other study ID #: CNVA237ADE02
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2013
• Last updated: December 19, 2014
• Start date: August 2013
• Est. completion date: January 2014

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• NVA237
NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)
• Tiotropium
Tiotropium 18 µg once daily delivered via HandiHaler® device.
• Placebo to NVA237
Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).
• Placebo to tiotropium
Placebo to tiotropium once daily delivered via HandiHaler® device
• Salbutamol
Used as resuce medication

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

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