Recent Updates
Recently added Catalysts

NVA237 100 µg

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |Novartis AG|Last Updated: May 21, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment281

FDA Designations

No designations recorded

Clinical trial landscape

NVA237 100 µg · 1 trial · 1 indication

Phase 2 1
NCT00510510Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease (COPD)
COMPLETED281 Analytics
PHASE2COMPLETED
Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
28 days

The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.

Secondary Endpoints

Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day
28 Days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NVA237 100 µgEXPERIMENTAL -
NVA237 200 µgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
NVA237 100 µgDRUGDry powder inhalation once a day for up to 28 days
PlaceboDRUGPlacebo to NVA237 dry powder inhalation once a day for up to 28 days
NVA237 200 µgDRUGDry powder inhalation once a day for up to 28 days
Unlock Study Design Details

Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Male or female adults aged 40 years or older * Patients with moderate to severe COPD according to the GOLD Guidelines (2006) * Patients who have smoking history of at least 10 pack years * Patients with a post-bronchodilator Forced Expiratory Volume in One Second (FEV1) equal ...

Countries:United StatesFranceGermanyNetherlandsSpainTurkey (Türkiye)
Unlock Eligibility Criteria

Frequently asked questions about NVA237 100 µg

What is NVA237 100 µg used for in COPD?

NVA237 100 µg is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is a glycopyrronium bromide formulation studied in patients with moderate to severe COPD. The drug is not approved and remains in clinical development.

What does NVA237 100 µg target?

NVA237 100 µg is a small molecule containing glycopyrronium bromide, an anticholinergic agent. It is being studied for its safety and tolerability in patients with moderate to severe COPD. The specific molecular target is not disclosed in the available information.

Who makes NVA237 100 µg?

NVA237 100 µg is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 2 clinical development for the treatment of Chronic Obstructive Pulmonary Disease (COPD).

What phase is NVA237 100 µg in?

NVA237 100 µg is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD) in patients with moderate to severe disease.

What clinical trials is NVA237 100 µg in?

NVA237 100 µg has one completed clinical trial, registered as NCT00510510. This Phase 2 study evaluated the safety and tolerability of 28 days of treatment with glycopyrronium bromide (NVA237) at 100 or 200 µg once daily in 281 patients with moderate to severe COPD. The trial was randomized, double-blind, and placebo-controlled.

Is NVA237 100 µg the same as glycopyrronium bromide?

NVA237 100 µg is a formulation of glycopyrronium bromide, an anticholinergic bronchodilator. The drug is being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The 100 µg dose refers to the amount of glycopyrronium bromide administered once daily in the clinical trial.