Clinical trial NCT01513460: Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease,
NVA 237,
glycopyrronium,
COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 773
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium)
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal)
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline in Mean Trough FEV1
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment
timeFrame: 12 weeks
measure: Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use
timeFrame: baseline, 12 weeks
measure: Mean Percentage of Nights With 'no Nighttime Awakenings'
timeFrame: 12 weeks
measure: Mean Percentage of Days With Performance of Usual Activities
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baulkham Hills
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Brookvale
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Castle Hill
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Dapto
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Ermington
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Gosford
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Hinchinbrook
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Kingswood
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Arundel
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Aspley
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Beenleigh
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Browns Plains
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Chemside
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Deception Bay
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Everton Plaza
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Holland Park
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Jimboomba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Kedron
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Kenmore
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Kippa Ring
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Logan Central
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Loganholme
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Mermaid Beach
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Morayfield
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Nerang
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Daw Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Glenelg East
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Golden Grove
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Hamley Bridge
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Kensington Gardens
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Prospect
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Dandenong
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Lalor
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Malvern
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Noble Park
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Oakleigh East
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Preston
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Rosebud
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Bicton
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: East Fremantle
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: East Victoria Park
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Fremantle
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Mirrabooka
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Morley
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Noranda
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Perth
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Perth
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Perth
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Pinjarra
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Spearwood
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Woodvale
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Yokine
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative Site
city: Dunedin
country: New Zealand
facility: Novartis Investigative Site
city: Grafton, Auckland
country: New Zealand
facility: Novartis Investigative Site
city: Hamilton
country: New Zealand
facility: Novartis Investigative Site
city: Tauranga
country: New Zealand
facility: Novartis Investigative Site
city: Tauranga
country: New Zealand
facility: Novartis Investigative Site
city: Wellington
country: New Zealand
facility: Novartis Investigative Site
city: Wellington
country: New Zealand
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.