Efficacy and safety of four doses of glycopyrronium bromide in patients with stable COPD, in comparison to an active comparator tiotropium.

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220418

Enrollment

Registered

2007-07-25

Start date

2007-07-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

investigational material(s) Generic name etc : NVA237|INN:Glycopyrronium bromide INN of investigational material : Therapeutic category code : 229 Other agents affecting respiratory organs Dosage and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: -Male or female adults aged >=40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. -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 FEV1 >=30% and 400/mm3, or onset of symptoms prior to age 40 years. -Patients contraindicated for tiotropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Efficacy primary endpoint:Trough FEV1 at day 7 of each treatment period. Trough FEV1 is defined as the mean of 23 hours 15 mins and 23 hours 45 mins post dose. Efficacy secondary endpoint:FEV1 and FVC: at time points: -45, -15, 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23h 15 min & 23h 45 min post dose on day 1 and day 7 of each treatment period. Safety assessments:Monitoring for adverse events, vital signs, ECGs and laboratory evaluations	—

Measure

Time frame

Efficacy primary endpoint:Trough FEV1 at day 7 of each treatment period. Trough FEV1 is defined as the mean of 23 hours 15 mins and 23 hours 45 mins post dose. Efficacy secondary endpoint:FEV1 and FVC: at time points: -45, -15, 5, 15, 30 minutes, 1, 2, 3, 4, 5, 23h 15 min & 23h 45 min post dose on day 1 and day 7 of each treatment period. Safety assessments:Monitoring for adverse events, vital signs, ECGs and laboratory evaluations

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026