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)

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) - CNVA237A2208

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34643

Enrollment

Registered

2010-04-01

Start date

2010-06-09

Completion date

Unknown

Last updated

2024-05-06

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

NVA237 or placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male or female adults aged 40 years and above. 2. Moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008). 3. Smoking history of at least 10 pack years. 4. Post-bronchodilator FEV1 >30% and

Exclusion criteria

Exclusion criteria: • Lower airway infection in the past 4 weeks. • Bronchial asthma. • Type I and uncontrolled type II diabetes. • a1-antitrypsin deficiency. • Other relevant pulmonary diseases. • Contra-indications for anticholinergics. • Use of ceratin COPD and other medications (see protocol for details). • Vaccination with live or inactivated vaccines in the past 30 and 2 days resp. • Longterm oxygen therapy. • Pregnancy and breast feeding. Inadequate contraception, if relevant.

Design outcomes

Primary

Measure	Time frame
Relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the maximal effect of NVA237. (Trough is defined as the mean of FEV1 measurements at 23 h 15 min and 23 h 45 min post morning dose).	—

Secondary

Measure	Time frame
Use of rescue medication, FEV1 (AUC 0-24 h and shorter intervals, peak and 12 h), FVC, safety.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)