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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: NVA237 50µg once daily (Drug); Tiotropium 18µg once daily (Drug); Flu/Sal (Drug); NVA237 placebo + Tiotropium placebo. (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.

Clinical Details

Official title: A Multicenter, Randomized, Blinded, Active-controlled, Parallel-group Study to Compare the Efficacy, Tolerability and Safety of NVA237 Compared to Tiotropium Added on to Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)

Secondary outcome:

Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)

Change From Baseline in Mean Trough FEV1

Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use

Mean Percentage of Nights With 'no Nighttime Awakenings'

Mean Percentage of Days With Performance of Usual Activities

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD

2010 guideline

- Current or ex-smokers who have a smoking history of at least 10 pack years

- Qualifying FEV1 at Visit 2 (day -7)

Exclusion Criteria:

- Patients with a history of asthma or a history of high blood eosinophil count

(>600/mm³)

- Patients with concomitant pulmonary disease

- Patients with lung lobectomy or lung volume reduction or lung transplantation

- Patients with α-1 antitrypsin deficiency

- Patients who have had live attenuated vaccinations within 30 days prior to screening

visit or during run-in period Other protocol-defined inclusion/exclusion criteria may apply.

Locations and Contacts

Novartis Investigative Site, Auckland 1051, New Zealand

Novartis Investigative Site, Auckland, New Zealand

Novartis Investigative Site, Christchurch, New Zealand

Novartis Investigative Site, Dunedin, New Zealand

Novartis Investigative Site, Grafton, Auckland 1010, New Zealand

Novartis Investigative Site, Hamilton 3240, New Zealand

Novartis Investigative Site, Tauranga 3143, New Zealand

Novartis Investigative Site, Tauranga, New Zealand

Novartis Investigative Site, Wellington 6021, New Zealand

Novartis Investigative Site, Wellington, New Zealand

Novartis Investigative Site, Baulkham Hills, New South Wales 2153, Australia

Novartis Investigative Site, Brookvale, New South Wales 2100, Australia

Novartis Investigative Site, Castle Hill, New South Wales 2067, Australia

Novartis Investigative Site, Dapto, New South Wales, Australia

Novartis Investigative Site, Darlinghurst, New South Wales 2010, Australia

Novartis Investigative Site, Ermington, New South Wales, Australia

Novartis Investigative Site, Gosford, New South Wales 2250, Australia

Novartis Investigative Site, Hinchinbrook, New South Wales 2168, Australia

Novartis Investigative Site, Kingswood, New South Wales 2747, Australia

Novartis Investigative Site, Sydney, New South Wales 2089, Australia

Novartis Investigative Site, Arundel, Queensland 4214, Australia

Novartis Investigative Site, Aspley, Queensland 4034, Australia

Novartis Investigative Site, Beenleigh, Queensland 4207, Australia

Novartis Investigative Site, Browns Plains, Queensland 4118, Australia

Novartis Investigative Site, Chemside, Queensland 4032, Australia

Novartis Investigative Site, Deception Bay, Queensland 4508, Australia

Novartis Investigative Site, Everton Plaza, Queensland 4053, Australia

Novartis Investigative Site, Holland Park, Queensland 4121, Australia

Novartis Investigative Site, Jimboomba, Queensland 4032, Australia

Novartis Investigative Site, Kedron, Queensland, Australia

Novartis Investigative Site, Kenmore, Queensland 4069, Australia

Novartis Investigative Site, Kippa Ring, Queensland 4021, Australia

Novartis Investigative Site, Logan Central, Queensland 4114, Australia

Novartis Investigative Site, Loganholme, Queensland 4129, Australia

Novartis Investigative Site, Mermaid Beach, Queensland 4218, Australia

Novartis Investigative Site, Morayfield, Queensland 4506, Australia

Novartis Investigative Site, Nerang, Queensland 4211, Australia

Novartis Investigative Site, Woolloongabba, Queensland 4102, Australia

Novartis Investigative Site, Adelaide, South Australia 5000, Australia

Novartis Investigative Site, Daw Park, South Australia 5041, Australia

Novartis Investigative Site, Glenelg East, South Australia 5045, Australia

Novartis Investigative Site, Golden Grove, South Australia 5125, Australia

Novartis Investigative Site, Hamley Bridge, South Australia 5401, Australia

Novartis Investigative Site, Kensington Gardens, South Australia 5065, Australia

Novartis Investigative Site, Prospect, South Australia 5082, Australia

Novartis Investigative Site, Dandenong, Victoria, Australia

Novartis Investigative Site, Lalor, Victoria 3075, Australia

Novartis Investigative Site, Malvern, Victoria 3144, Australia

Novartis Investigative Site, Melbourne, Victoria, Australia

Novartis Investigative Site, Noble Park, Victoria 3174, Australia

Novartis Investigative Site, Oakleigh East, Victoria 3166, Australia

Novartis Investigative Site, Preston, Victoria, Australia

Novartis Investigative Site, Rosebud, Victoria 3063, Australia

Novartis Investigative Site, Bicton, Western Australia, Australia

Novartis Investigative Site, East Fremantle, Western Australia 6158, Australia

Novartis Investigative Site, East Victoria Park, Western Australia 6101, Australia

Novartis Investigative Site, Fremantle, Western Australia 6160, Australia

Novartis Investigative Site, Mirrabooka, Western Australia 6061, Australia

Novartis Investigative Site, Morley, Western Australia 6062, Australia

Novartis Investigative Site, Nedlands, Western Australia 6009, Australia

Novartis Investigative Site, Noranda, Western Australia, Australia

Novartis Investigative Site, Perth, Western Australia 6000, Australia

Novartis Investigative Site, Perth, Western Australia 6069, Australia

Novartis Investigative Site, Perth, Western Australia, Australia

Novartis Investigative Site, Pinjarra, Western Australia, Australia

Novartis Investigative Site, Spearwood, Western Australia 6163, Australia

Novartis Investigative Site, Woodvale, Western Australia 6026, Australia

Novartis Investigative Site, Yokine, Western Australia 6060, Australia

Additional Information

Starting date: April 2012
Last updated: December 23, 2014

Page last updated: August 23, 2015

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