Clinical trial NCT01005901: A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
Official title: A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
NVA
FEV1
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 1324
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: A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

* Smoking history of at least 10 pack-years
* Post-bronchodilator FEV1 \< 80% and ≥ 30% of the predicted normal value
* Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70%

Exclusion Criteria:

1. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
2. Patients with concomitant pulmonary disease
3. Patients with a history of asthma
4. Any patient with lung cancer or a history of lung cancer
5. Patients with a history of certain cardiovascular comorbid conditions
6. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
7. Patients in the active phase of a supervised pulmonary rehabilitation program
8. Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment
timeFrame: 26 weeks
measure: Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment
timeFrame: 26 weeks
measure: Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment
timeFrame: 26 weeks
measure: Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26)
timeFrame: 26 weeks
measure: FEV1 at Each Time-point on Day 1 and Week 26
timeFrame: Day 1 and Week 26
measure: Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26
timeFrame: Day 1 and Week 26
measure: FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26
timeFrame: Day 1, Week 12 and Week 26
measure: FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26
timeFrame: Week 12 and Week 26
measure: Trough FEV1 and FVC at Day 1 and Week 26
timeFrame: Day 1 and Week 26
measure: Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26
timeFrame: Baseline, Day 1, Week 12 and Week 26
measure: Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations
timeFrame: 26 Weeks and 30 Day follow-up
measure: Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period
timeFrame: 26 weeks
measure: Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period
timeFrame: 26 Weeks
measure: Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period
timeFrame: 26 Weeks
measure: Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period
timeFrame: 26 Weeks
measure: Mean Daily Total Symptom Score Over the 26 Week Treatment Period
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Fairhope
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Glendale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Novartis Investigative Site
state: California
city: Newark
country: United States
facility: Novartis Investigative Site
state: Delaware
city: Port Orange
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tamarac
country: United States
facility: Novartis Investigative Site
state: Florida
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Madisonville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Slidell
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Biddeford
country: United States
facility: Novartis Investigative Site
state: Maine
city: Pikesville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Ann Arbor
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Livonia
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Charles
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Missoula
country: United States
facility: Novartis Investigative Site
state: Montana
city: Bellevue
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Reno
country: United States
facility: Novartis Investigative Site
state: Nevada
city: New Brunswick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Rhode Island
city: Johnson City
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Corpus Christi
country: United States
facility: Novartis Investigative Site
state: Texas
city: McKinney
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Daw Park SA
country: Australia
facility: Novartis Investigative Site
city: Bridgewater
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Courtice
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mississuaga
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: North York
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Asahikawa
country: Japan
facility: Novartis Investigative Site
city: Hamakita
country: Japan
facility: Novartis Investigative Site
city: Himeji
country: Japan
facility: Novartis Investigative Site
city: Hitachi
country: Japan
facility: Novartis Investigative Site
city: Kishiwada
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
city: Matsue
country: Japan
facility: Novartis Investigative Site
city: Matsusaka
country: Japan
facility: Novartis Investigative Site
city: Moriya
country: Japan
facility: Novartis Investigative Site
city: Naka-gun
country: Japan
facility: Novartis Investigative Site
city: Obihiro
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Ota
country: Japan
facility: Novartis Investigative Site
city: Otsu
country: Japan
facility: Novartis Investigative Site
city: Sapporo
country: Japan
facility: Novartis Investigative Site
city: Takatsuki
country: Japan
facility: Novartis Investigative Site
city: Tokyo
country: Japan
facility: Novartis Investigative Site
city: Yabu
country: Japan
facility: Novartis Investigative Site
city: Yonezawa
country: Japan
facility: Novartis Investigative Site
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative site
city: Almelo
country: Netherlands
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Harderwijk
country: Netherlands
facility: Novartis Investigative Site
city: Heerlen
country: Netherlands
facility: Novartis Investigative Site
city: Zutphen
country: Netherlands
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Iasi
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Irkutsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnodar
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: N. Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Sochy
country: Russian Federation
facility: Novartis Investigative Site
city: Stavropol
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Badalona
country: Spain
facility: Novartis Investigative Site
city: Caceres
country: Spain
facility: Novartis Investigative Site
city: Canet de Mar
country: Spain
facility: Novartis Investigative Site
city: Centelles
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Altunizade
country: Turkey
facility: Novartis Investigative Site
city: Aydin
country: Turkey
facility: Novartis Investigative Site
city: Diyarbakir
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Kinikli/Denizli
country: Turkey
facility: Novartis Investigative Site
city: Mersin
country: Turkey
facility: Novartis Investigative Site
city: Soke/Aydin
country: Turkey
facility: Novartis Investigative Site
city: Yenisehir/Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: D'Urzo A, Ferguson GT, van Noord JA, Hirata K, Martin C, Horton R, Lu Y, Banerji D, Overend T. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respir Res. 2011 Dec 7;12(1):156. doi: 10.1186/1465-9921-12-156.
citation: D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.