Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT01566604

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-06-30

Brief Summary

This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237 in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks treatment.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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

Study Groups

NVA237

NVA237 50 µg once daily delivered via a single dose dry powder inhaler

Group Type: EXPERIMENTAL

NVA237

Intervention Type: DRUG

Delivered via a single dose dry powder inhaler

Placebo

Placebo once daily delivered via a single dose dry powder inhaler

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Delivered via a single dose dry powder inhaler

Interventions

NVA237

Delivered via a single dose dry powder inhaler

Intervention Type: DRUG

Placebo

Delivered via a single dose dry powder 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
• With moderate to severe stable COPD (Stage II or Stage III).
• 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).
• Post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14) (post means: record FEV1 and FVC 45 min after administering ipratropium).
• Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -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

• With a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
• Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years. Patients without asthma but who have a blood eosinophil count >600/mm3 at Visit 2 are excluded.
• Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder.
• Patients with lung lobectomy or lung volume reduction or lung transplantation.
• Patients with known history and diagnosis of α-1 antitrypsin deficiency.
• Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.

• 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_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Beijing, Beijing Municipality, China

Novartis Investigative Site

Beijing, Beijing Municipality, China

Novartis Investigative Site

Nanning, Guangxi, China

Novartis Investigative Site

Shijiazhuang, Hebei, China

Novartis Investigative Site

Changsha, Hunan, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Suzhou, Jiangsu, China

Novartis Investigative Site

Nanchang, Jiangxi, China

Novartis Investigative Site

Shengyang, Liaoning, China

Novartis Investigative Site

Shanghai, Shanghai Municipality, China

Novartis Investigative Site

Xi’an, Shanxi, China

Novartis Investigative Site

Chengdu, Sichuan, China

Novartis Investigative Site

Beijing, , China

Novartis Investigative Site

Beijing, , China

Novartis Investigative Site

Chongqing, , China

Novartis Investigative Site

Chongqing, , China

Novartis Investigative Site

Chongqing, , China

Novartis Investigative Site

Guangzhou, , China

Novartis Investigative Site

Shanghai, , China

Novartis Investigative Site

Shanghai, , China

Novartis Investigative Site

Tianjin, , China

Novartis Investigative Site

Dehli, New Delhi, India

Novartis Investigative Site

Coimbatore, Tamil Nadu, India

Novartis Investigative Site

Bulacan, Philippines, Philippines

Novartis Investigative Site

Manila, Philippines, Philippines

Novartis Investigative Site

Las Piñas, , Philippines

Novartis Investigative Site

Quezon City, , Philippines

Novartis Investigative Site

Seoul, Seoul, South Korea

Novartis Investigative Site

Seoul, Seoul, South Korea

Novartis Investigative Site

Daejeon, , South Korea

Novartis Investigative Site

Incheon, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Countries

China; India; Philippines; South Korea

Other Identifiers

CNVA237A2309

Identifier Type: -

Identifier Source: org_study_id