Clinical trial NCT01715298: NVA237 BID Versus Placebo Twelve-week Efficacy Study
Official title: A 12-week Multi-center, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of NVA237 in Stable COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Anticholinergic
Antimuscarinic
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease
Chronic Obstructive Pulmonary Disease
COPD
LAMA
Lung Disease
Lung Diseases, Obstructive
Lung Function
Muscarinic receptor antagonist
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 432
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: The study serves to determine whether the treatment of patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is efficient and safe. The efficacy and safety of the drug will be tested against a placebo treatment. The primary criterion to assess efficacy will be the difference between the serial lung function measurements of patients who have been treated for 12 weeks with NVA237 versus those that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1 testing) will be conducted and the "area under the curve" will be the measure for the ability to breathe.


Eligibility criteria: Inclusion criteria: 1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with airflow obstruction of level 2 and 3 according to the current Global initiative for chronic Obstructive Lung Disease (GOLD) strategy (2011). 2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and \<80 % of the predicted normal, and FEV1/FVC \< 0.70 when measured 45 min after the inhalation of 84 µg ipratropium bromide.

3. Current or ex-smokers with at least 10 cigarette pack years smoking history.

Exclusion criteria:

1. Patients with a history of long QT syndrome, with a prolonged QTc measured during screening, or patients who have a clinically significant ECG abnormality at screening.
2. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using an effective method of contraception.
4. Patients who in the judgment of the investigator, would be at potential risk if enrolled into the study.
5. Patients who have a clinically significant concomitant disease at screening, including but not limited to clinically significant laboratory abnormalities, clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with uncontrolled diabetes, which could interfere with the assessment of the efficacy and safety of the study treatment.
6. Patients with a body mass index (BMI) of more than 40 kg/m2.
7. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or sympathomimetic amines.
8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or patients with a high blood eosinophil count during screening.

Other protocol-defnied inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in Standardized Area Under the Curve for Forced Expiratory Volume in One Second Post Dosing
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Standardized Area Under the Curve (AUC(0-12h)) for Forced Expiratory Volume in One Second Post Dosing
timeFrame: Day 1
measure: Change From Baseline in Standardized Area Under The Curve for Forced Expiratory Volume in One Second for Different Time Spans Post Dosing
timeFrame: Day 1 and Week 12
measure: Change From Baseline in Forced Expiratory Volume in One Second at All Individual Timepoints
timeFrame: Day 1 and week 12
measure: Mean Trough Forced Expiratory Volume in One Second
timeFrame: Day 1 and week 12
measure: Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire
timeFrame: Week 12
measure: Breathlessness Assessed by Transition Dyspnea Index
timeFrame: Week 12
measure: Change From Baseline in Mean Number of Puffs of Rescue Medication Per Day
timeFrame: Baseline and week 12
measure: Change From Baseline in the Percentage of Days Without Rescue Medication Use
timeFrame: Baseline and week 12
measure: Change From Baseline in Daily Symptom Scores
timeFrame: day 1 to week 12
measure: Change From Baseline in the Percentage of Nights With "no Nighttime Awakenings"
timeFrame: Day 1 and week 12
measure: Change From Baseline in the Percentage of Days With "no Daytime Symptoms"
timeFrame: Day 1 to week 12
measure: Change From Baseline in Percentage of "Days Able to Perform Usual Daily Activities"
timeFrame: Day 1 to week 12
measure: Change From Baseline in Forced Vital Capacity at All Individual Timepoints
timeFrame: Day 1 and week 12
measure: Change From Baseline in Mean Trough Forced Vital Capacity
timeFrame: Day 1 and week 12
measure: Change From Baseline in Morning and Nighttime Symptom Scores
timeFrame: Day 1 to week 12
Other outcomes:
Locations:
city: *See Various Dept.'s*
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Chandler
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state: Arizona
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state: California
city: Fullerton
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state: California
city: Yorba Linda
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state: California
city: Yorba Linda
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city: Wheat Ridge
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city: Skokie
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city: Sunset
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state: Louisiana
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state: Massachusetts
city: North Dartmouth
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state: Massachusetts
city: Minneapolis
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city: St. Charles
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state: Missouri
city: St. Louis
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city: Fremont
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state: Nebraska
city: Lincoln
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state: Nebraska
city: Omaha
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state: Nebraska
city: Cherry Hill
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state: New Jersey
city: Albuquerque
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state: New Mexico
city: Brooklyn
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state: New York
city: Brooklyn
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state: New York
city: Great Neck
country: United States
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state: New York
city: Massapequa
country: United States
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state: New York
city: New Windsor
country: United States
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state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
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state: New York
city: Charlotte
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state: North Carolina
city: Cincinnati
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state: Ohio
city: Cincinnati
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state: Ohio
city: Cincinnati
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state: Ohio
city: Columbus
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state: Ohio
city: Medford
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state: Oregon
city: Medford
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state: Oregon
city: Portland
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state: Oregon
city: Langhorne
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city: Pittsburgh
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city: Pottstown
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city: Tipton
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state: Pennsylvania
city: East Providence
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state: Rhode Island
city: Fort Mill
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state: South Carolina
city: Rock Hll
country: United States
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state: South Carolina
city: Denton
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: Midvale
country: United States
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state: Utah
city: South Burlington
country: United States
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state: Vermont
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Kerwin E, Siler TM, Korenblat P, White A, Eckert JH, Henley M, Patalano F, D'Andrea P. Efficacy and Safety of Twice-Daily Glycopyrrolate Versus Placebo in Patients With COPD: The GEM2 Study. Chronic Obstr Pulm Dis. 2016 Mar 28;3(2):549-559. doi: 10.15326/jcopdf.3.2.2015.0157.