Efficacy and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A randomized, double-blind, placebo-controlled, 2-period, cross-over study to assess the efficacy and safety of differing doses of NVA237 administered either once daily or twice daily, in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000285

Enrollment

360

Registered

2010-07-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease

Interventions

Intervention1: NVA237: NVA237 group 2: Experimental-12.5 microgram b.i.d Intervention2: NVA237: NVA237 group 1: Experimental-12.5 microgram q.d. Intervention3: NVA237: NVA237 group 3: Experimental-25

Eligibility

Inclusion criteria

Inclusion criteria: Male and Female patients age 40 years or more Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) Smoking history of at least 10 pack-years Post-bronchodilator FEV1 =30% of the predicted normal value Post-bronchodilator FEV1/FVC (forced vital capacity)

Exclusion criteria

Exclusion criteria: *Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to the first visit * Patients who have had a respiratory tract infection within 4 weeks prior to the first visit * Patients with concomitant pulmonary disease or a history of asthma * Patients with diabetes Type I or uncontrolled diabetes Type II * Any patient with lung cancer or a history of lung cancer * Patients with a history of certain cardiovascular comorbid conditions * Patients with eczema, known high IgE levels or a known positive skin prick test * Patients participating in the active phase of a pulmonary rehabilitation programme * Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
To evaluate the relationship of NVA237 on trough forced expiratory volume in one second (FEV1)Timepoint: Time Frame: 28 days	—

Secondary

Measure	Time frame
To evaluate the relationship of NVA237 on FEV1 AUC0-24 hoursTimepoint: Time Frame: 28 days;To evaluate the safety and tolerability of NVA237 over the course of treatmentTimepoint: Time Frame: 28 days	—

Countries

India

Contacts

Public ContactDr. Kamala Rai

kamala.rai@novartis.com022 -24958533

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026