Clinical trial NCT01922271: Efficacy of NVA237 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-08-14
Enrollment: 152
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2
timeFrame: Day 1
Secondary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose
timeFrame: Day 1
measure: Specific Airway Resistance (sRAW)
timeFrame: Day 1
measure: Functional Resistance Capacity (FRCpleth)
timeFrame: Day 1
measure: Residual Volume (RV)
timeFrame: Day 1
measure: Total Lung Capacity (TLC)
timeFrame: Day 1
measure: Inspiratory Capacity (IC)
timeFrame: Day 1
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gelsenkirchen
country: Germany
facility: Novartis Investigative Site
city: Grosshansdorf
country: Germany
facility: Novartis Investigative Site
city: Gummersbach
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Rüdersdorf
country: Germany
facility: Novartis Investigative Site
city: Sonneberg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Watz H, Mailander C, May C, Baier M, Kirsten AM. Fast onset of action of glycopyrronium compared with tiotropium in patients with moderate to severe COPD - A randomised, multicentre, crossover trial. Pulm Pharmacol Ther. 2017 Feb;42:13-20. doi: 10.1016/j.pupt.2016.12.001. Epub 2016 Dec 9.