Long Term Safety and Tolerability of NVA237 Versus Tiotropium in Japanese Patients

NCT01119937 | Completed Phase 3 Results

• 1 other identifier: CNVA237A1302
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 40

Brief Summary

This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; NVA237

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events, Serious Adverse Events or Death

  Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.

  52 weeks

Secondary Outcomes (10)

• Change in Pre-dose FEV1 From Baseline

  Weeks 12, 24, 36 and 52

• Change in Pre-dose FVC From Baseline

  Weeks 12, 24, 36 and 52

• Time From Randomization Until the Start of the First Moderate or Severe COPD Exacerbation

  52 weeks

• Number of Patients With Moderate or Severe COPD Exacerbations

  52 weeks

• Change in St. George Respiratory Questionnaire From Baseline

  Weeks 12, 24, 36, 52

Study Arms (2)

NVA237

EXPERIMENTAL

50µg once daily

Drug: NVA237

Tiotropium

EXPERIMENTAL

18µg once daily

Drug: Tiotropium

Interventions

NVA237 DRUG

50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®)

NVA237

Tiotropium DRUG

18µg capsules for inhalation, delivered via HandiHaler®

Tiotropium

Eligibility Criteria

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

You may qualify if:

• Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline 2008.
• Current or ex-smokers who have a smoking history of at least 10 pack years.
• Patients with a post-bronchodilator FEV1 ≥30% and \< 80% of the predicted normal, and postbronchodilator FEV1/FVC \< 0.7 at Visit 2 (day -7)

You may not qualify if:

• Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
• Patients requiring long term oxygen therapy
• Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
• Patients with concomitant pulmonary disease
• Patients with a history of asthma
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular comorbid conditions
• Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
• Patients in the active phase of a supervised pulmonary rehabilitation program
• Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (40)

Novartis Investigative Site

Fukuoka, Fukuoka, 812-0033, Japan

Location

Novartis Investigative Site

Iizuka, Fukuoka, 820-8505, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 802-0083, Japan

Location

Novartis Investigative Site

Kitakyushu, Fukuoka, 820-0052, Japan

Location

Novartis Investigative Site

Kurume, Fukuoka, 830-0011, Japan

Location

Novartis Investigative Site

Ōnojō, Fukuoka, 816-0931, Japan

Location

Novartis Investigative Site

Yanagawa, Fukuoka, 832-0059, Japan

Location

Novartis Investigative Site

Asahikawa, Hokkaido, 070-8644, Japan

Location

Novartis Investigative Site

Obihiro, Hokkaido, 080-0805, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060-8648, Japan

Location

Novartis Investigative Site

Himeji, Hyōgo, 672-8064, Japan

Location

Novartis Investigative Site

Takarazuka, Hyōgo, 665-0827, Japan

Location

Novartis Investigative Site

Yabu, Hyōgo, 667-8555, Japan

Location

Novartis Investigative Site

Inashiki-gun, Ibaraki, 300-0395, Japan

Location

Novartis Investigative Site

Naka-gun, Ibaraki, 319-1113, Japan

Location

Novartis Investigative Site

Sashima-gun, Ibaraki, 306-0433, Japan

Location

Novartis Investigative Site

Morioka, Iwate, 020-0055, Japan

Location

Novartis Investigative Site

Kawasaki, Kanagawa, 210-0852, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 232-0021, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa, 236-0051, Japan

Location

Novartis Investigative Site

Kochi, Kochi, 780-8077, Japan

Location

Novartis Investigative Site

Uji, Kyoto, 611-0042, Japan

Location

Novartis Investigative Site

Matsusaka, Mie-ken, 515-8544, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 981-8563, Japan

Location

Novartis Investigative Site

Nagaoka, Niigata, 940-2085, Japan

Location

Novartis Investigative Site

Nagaoka, Niigata, 940-8653, Japan

Location

Novartis Investigative Site

Kasaoka, Okayama-ken, 714-0081, Japan

Location

Novartis Investigative Site

Tsuyama, Okayama-ken, 708-0841, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 530-0012, Japan

Location

Novartis Investigative Site

Osaka, Osaka, 545-8586, Japan

Location

Novartis Investigative Site

Sakai, Osaka, 591-8555, Japan

Location

Novartis Investigative Site

Sayama, Osaka, 589-0022, Japan

Location

Novartis Investigative Site

Takatsuki, Osaka, 569-1096, Japan

Location

Novartis Investigative Site

Saitama, Saitama, 337-0012, Japan

Location

Novartis Investigative Site

Shimotsuka-gun, Tochigi, 321-0293, Japan

Location

Novartis Investigative Site

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Novartis Investigative Site

Nakano-ku, Tokyo, 164-0012, Japan

Location

Novartis Investigative Site

Ohta-ku, Tokyo, 140-0063, Japan

Location

Novartis Investigative Site

Yamagata, Yamagata, 990-8533, Japan

Location

Novartis Investigative Site

Ube, Yamaguchi, 755-0241, Japan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; Tiotropium Bromide

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; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 10, 2010
• Study Start: May 1, 2010
• Primary Completion: November 1, 2011
• Last Updated: January 18, 2013
• Results First Posted: January 18, 2013

Record last verified: 2012-11

Locations

JP (40)