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

NCT01566604 | Completed Phase 3 Results

• 1 other identifier: CNVA237A2309
• Study Type: interventional
• Target: 460
• Locations: 4 countries
• Sites: 32

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)

Keywords

Chronic obstructive pulmonary disease (COPD); NVA237

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in One Second (FEV1)

  Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.

  12 weeks

Secondary Outcomes (10)

• Transition Dyspnea Index (TDI) Score

  Baseline, week 12, week 26

• Change From Baseline in Daily Rescue Medication Use (Number of Puffs)

  Baseline, 26 weeks

• 24h Trough FEV1

  Day 1, Week 26

• FEV1 and Forced Vital Capacity (FVC)

  Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose

• Peak FEV1

  Day 1, week 12, week 26

Study Arms (2)

NVA237

EXPERIMENTAL

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

Drug: NVA237

Placebo

PLACEBO COMPARATOR

Placebo once daily delivered via a single dose dry powder inhaler

Drug: Placebo

Interventions

NVA237 DRUG

Delivered via a single dose dry powder inhaler

NVA237

Placebo DRUG

Delivered via a single dose dry powder inhaler

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (32)

Novartis Investigative Site

Beijing, Beijing Municipality, 100023, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

Location

Novartis Investigative Site

Nanning, Guangxi, 530021, China

Location

Novartis Investigative Site

Shijiazhuang, Hebei, 050000, China

Location

Novartis Investigative Site

Changsha, Hunan, 410011, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, China

Location

Novartis Investigative Site

Suzhou, Jiangsu, 215004, China

Location

Novartis Investigative Site

Nanchang, Jiangxi, 330006, China

Location

Novartis Investigative Site

Shengyang, Liaoning, 110016, China

Location

Novartis Investigative Site

Shanghai, Shanghai Municipality, 200433, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710032, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Beijing, 100029, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Chongqing, 400037, China

Location

Novartis Investigative Site

Chongqing, 400038, China

Location

Novartis Investigative Site

Chongqing, 400042, China

Location

Novartis Investigative Site

Guangzhou, 510080, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

Novartis Investigative Site

Tianjin, 300052, China

Location

Novartis Investigative Site

Dehli, New Delhi, 110063, India

Location

Novartis Investigative Site

Coimbatore, Tamil Nadu, 641 045., India

Location

Novartis Investigative Site

Bulacan, Philippines, 3020, Philippines

Location

Novartis Investigative Site

Manila, Philippines, 1000, Philippines

Location

Novartis Investigative Site

Las Piñas, 1740, Philippines

Location

Novartis Investigative Site

Quezon City, 1100, Philippines

Location

Novartis Investigative Site

Seoul, Seoul, 130-709, South Korea

Location

Novartis Investigative Site

Seoul, Seoul, 150-713, South Korea

Location

Novartis Investigative Site

Daejeon, 301-804, South Korea

Location

Novartis Investigative Site

Incheon, 403-010, South Korea

Location

Novartis Investigative Site

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 8, 2014
• Results First Posted: August 8, 2014

Record last verified: 2014-07

Locations

KR (5); IN (2); PH (4); CN (21)