A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo

A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000910

Enrollment

800

Registered

2009-12-23

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: NVA237A: Glycopyrronium bromide 50&micro

g delivered once daily via Single Dose Dry Powder Inhaler (SDDPI) Control Intervention1: Placebo Comparator: Placebo delivered once daily via SDDPI

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or female adults aged >=40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure. 2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008). 3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.) 4. Patients with a post-bronchodilator FEV1 >=30% and FEV1/FVC 5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3.

Exclusion criteria

Exclusion criteria: 1.Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1 2.Patients with concomitant pulmonary disease 3.Patients with a history of asthma 4.Any patient with lung cancer or a history of lung cancer 5.Patients with a history of certain cardiovascular comorbid conditions 6.Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency 7.Patients in the active phase of a supervised pulmonary rehabilitation program 8.Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Trough Forced Expiratory Volume in 1 Second (FEV1)Timepoint: 12 weeks	—

Secondary

Measure	Time frame
* George's Respiratory Questionnaire (SGRQ)Timepoint: 26 weeks;* Transition Dyspnea Index (TDI)Timepoint: 26 weeks	—

Countries

India

Contacts

Public ContactMuruganananthan K

murugananthan.k@novartis.com02224958545

Outcome results

None listed

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