Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium

NCT ID: NCT00501852

Last Updated: 2012-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31

Brief Summary

This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

NVA237 12.5 µg

12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

single-dose dry-powder inhaler (SDDPI)

NVA237 25 µg

25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

single-dose dry-powder inhaler (SDDPI)

NVA237 50 µg

50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

single-dose dry-powder inhaler (SDDPI)

NVA237 100 µg

100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

single-dose dry-powder inhaler (SDDPI)

Placebo

Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single-dose dry-powder inhaler (SDDPI)

Tiotropium 18 µg

18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.

Group Type: ACTIVE_COMPARATOR

Tiotropium

Intervention Type: DRUG

Handihaler inhaler

Interventions

NVA237

single-dose dry-powder inhaler (SDDPI)

Intervention Type: DRUG

Placebo

single-dose dry-powder inhaler (SDDPI)

Intervention Type: DRUG

Tiotropium

Handihaler inhaler

Intervention Type: DRUG

Eligibility 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. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
• Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) < 0.7 at Visit 2. For non-Japanese patients predicted FEV1 should be calculated according to Quanjer predictive equations [Quanjer PH 1993], for Japanese patients predicted FEV1 should be calculated according to Japanese Respiratory Society predictive tables [Japan Respiratory Society 2001].

Exclusion Criteria

• Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
• Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
• Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients who develop a respiratory tract infection during the screening period (up to Visit 3) must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
• Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, cancers, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia (all), narrow angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.
• Patients with a history of asthma indicated by (but not limited to):

1. Blood eosinophil count > 400/mm3

2. Onset of symptoms prior to age 40 years.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

Novartis Investigator Site

Vilvoorde, , Belgium

Novartis Investigator Site

Rueil-Malmaison, , France

Novartis Investigator site

Tokyo, , Japan

Countries

Belgium; France; Japan

References

Verkindre C, Fukuchi Y, Flemale A, Takeda A, Overend T, Prasad N, Dolker M. Sustained 24-h efficacy of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Respir Med. 2010 Oct;104(10):1482-9. doi: 10.1016/j.rmed.2010.04.006. Epub 2010 Jun 11.

Reference Type: DERIVED

PMID: 20541381 (View on PubMed)

Other Identifiers

CNVA237A2205

Identifier Type: -

Identifier Source: org_study_id