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

NCT ID: NCT01513460

Last Updated: 2015-01-05

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

773 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NVA237 + Fluticasone/Salmeterol (Flu/Sal)

NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

Group Type EXPERIMENTAL

NVA237 50µg once daily

Intervention Type DRUG

NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI)

Flu/Sal

Intervention Type DRUG

Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device

NVA237 placebo + Tiotropium placebo.

Intervention Type DRUG

Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Tiotropium + Flu/Sal

Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

Group Type ACTIVE_COMPARATOR

Tiotropium 18µg once daily

Intervention Type DRUG

Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Flu/Sal

Intervention Type DRUG

Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device

NVA237 placebo + Tiotropium placebo.

Intervention Type DRUG

Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Flu/Sal

Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.

Group Type PLACEBO_COMPARATOR

Flu/Sal

Intervention Type DRUG

Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device

NVA237 placebo + Tiotropium placebo.

Intervention Type DRUG

Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Interventions

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NVA237 50µg once daily

NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI)

Intervention Type DRUG

Tiotropium 18µg once daily

Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Intervention Type DRUG

Flu/Sal

Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device

Intervention Type DRUG

NVA237 placebo + Tiotropium placebo.

Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Baulkham Hills, New South Wales, Australia

Site Status

Novartis Investigative Site

Brookvale, New South Wales, Australia

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Castle Hill, New South Wales, Australia

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Dapto, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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Ermington, New South Wales, Australia

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Gosford, New South Wales, Australia

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Hinchinbrook, New South Wales, Australia

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Kingswood, New South Wales, Australia

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Sydney, New South Wales, Australia

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Arundel, Queensland, Australia

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Aspley, Queensland, Australia

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Beenleigh, Queensland, Australia

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Browns Plains, Queensland, Australia

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Chemside, Queensland, Australia

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Deception Bay, Queensland, Australia

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Everton Plaza, Queensland, Australia

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Holland Park, Queensland, Australia

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Jimboomba, Queensland, Australia

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Kedron, Queensland, Australia

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Kenmore, Queensland, Australia

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Kippa-Ring, Queensland, Australia

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Logan Central, Queensland, Australia

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Loganholme, Queensland, Australia

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Mermaid Beach, Queensland, Australia

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Morayfield, Queensland, Australia

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Nerang, Queensland, Australia

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Woolloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Daw Park, South Australia, Australia

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Glenelg East, South Australia, Australia

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Golden Grove, South Australia, Australia

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Hamley Bridge, South Australia, Australia

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Kensington Gardens, South Australia, Australia

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Prospect, South Australia, Australia

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Dandenong, Victoria, Australia

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Lalor, Victoria, Australia

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Malvern, Victoria, Australia

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Melbourne, Victoria, Australia

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Noble Park, Victoria, Australia

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Oakleigh East, Victoria, Australia

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Preston, Victoria, Australia

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Rosebud, Victoria, Australia

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Bicton, Western Australia, Australia

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East Fremantle, Western Australia, Australia

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East Victoria Park, Western Australia, Australia

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Fremantle, Western Australia, Australia

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Mirrabooka, Western Australia, Australia

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Morley, Western Australia, Australia

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Nedlands, Western Australia, Australia

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Noranda, Western Australia, Australia

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Perth, Western Australia, Australia

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Perth, Western Australia, Australia

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Perth, Western Australia, Australia

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Pinjarra, Western Australia, Australia

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Spearwood, Western Australia, Australia

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Woodvale, Western Australia, Australia

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Yokine, Western Australia, Australia

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Auckland, New Zealand, New Zealand

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Auckland, New Zealand, New Zealand

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Christchurch, New Zealand, New Zealand

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Hamilton, New Zealand, New Zealand

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Tauranga, New Zealand, New Zealand

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Tauranga, New Zealand, New Zealand

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Tauranga, Tauranga, New Zealand

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Wellington, Wellington Region, New Zealand

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Auckland, , New Zealand

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Christchurch, , New Zealand

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Dunedin, , New Zealand

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Grafton, Auckland, , New Zealand

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Novartis Investigative Site

Wellington, , New Zealand

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Countries

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Australia New Zealand

References

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Frith PA, Thompson PJ, Ratnavadivel R, Chang CL, Bremner P, Day P, Frenzel C, Kurstjens N; Glisten Study Group. Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial. Thorax. 2015 Jun;70(6):519-27. doi: 10.1136/thoraxjnl-2014-206670. Epub 2015 Apr 3.

Reference Type DERIVED
PMID: 25841237 (View on PubMed)

Other Identifiers

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CNVA237AAU01

Identifier Type: -

Identifier Source: org_study_id

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