Clinical trial NCT01709864: NVA237 Versus Placebo 12-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: 2012-10-18
Enrollment: 440
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/ Forced Vital Capacity (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-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline of Standardized Area Under the Curve (AUC) for Forced Expiratory Volume in One Second (FEV1) Post Dosing
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Trough FEV1 and Pre-dose Trough FEV1 by Visit
timeFrame: Day 2, 86 (trough) Day 15, 29, 57, 85 (pre-dose trough)
measure: Change From Baseline in FEV1 AUC (0-12H) at Day 1 and FEV1 AUC (0-4h), AUC (4-8h), AUC (8-12h) at Day 1 and Week 12 (Day 85)
timeFrame: Day 1 and Week 12 (Day 85)
measure: Change From Baseline in the Health Status Assessed by St. George's Respiratory Questionnaire
timeFrame: Week 12
measure: Percentage of Participants With a Clinically Important Improvement of >=4units in the SGRQ Total Score at Week 12
timeFrame: Week 12
measure: Breathlessness Assessed by Transition Dyspnea Index (TDI) Focal Score at Week 12
timeFrame: Week 12
measure: Change From Baseline of Daily Symptom Scores
timeFrame: 12 weeks
measure: Change From Baseline of Morning and Nighttime Symptom Scores at Week 12
timeFrame: 12 weeks
measure: Percentage of Nights With "no Nighttime Awakenings"
timeFrame: from Baseline up to 12 weeks
measure: Percentage of Days With "no Daytime Symptoms"
timeFrame: from Baseline up to 12 weeks
measure: Percentage of "Days Able to Perform Usual Daily Activities"
timeFrame: from Baseline up to 12 weeks
measure: The Average Number of Puffs of Rescue Medication Per Day
timeFrame: baseline and 12 weeks
measure: Percentage of Days Without Rescue Medication Use
timeFrame: 12 weeks
measure: Change From Baseline of Forced Vital Capacity (FVC) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)
timeFrame: Baseline, Day 1 and Week 12 (Day 85)
measure: Change From Baseline of Forced Expiratory Volume in One Second (FEV1) at All Individual Timepoints at Day 1 and at Week 12 (Day 85)
timeFrame: Baseline, Day 1 and Week 12 (Day 85)
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Jasper
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facility: Novartis Investigative Site
state: Alabama
city: *See Various Dept.'s*
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Tucson
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facility: Novartis Investigative Site
state: Arizona
city: Fountain Valley
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facility: Novartis Investigative Site
state: California
city: Fullerton
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: Los Angeles
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facility: Novartis Investigative Site
state: California
city: Riverside
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facility: Novartis Investigative Site
state: California
city: San Diego
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facility: Novartis Investigative Site
state: California
city: San Diego
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facility: Novartis Investigative Site
state: California
city: Brandon
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facility: Novartis Investigative Site
state: Florida
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city: Edgewater
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facility: Novartis Investigative Site
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city: Hialeah
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facility: Novartis Investigative Site
state: Florida
city: Miami
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facility: Novartis Investigative Site
state: Florida
city: Miami
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facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
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facility: Novartis Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pompano Beach
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facility: Novartis Investigative Site
state: Florida
city: Port Orange
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facility: Novartis Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Novartis Investigative Site
state: Florida
city: South Miami
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facility: Novartis Investigative Site
state: Florida
city: Summerfield
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facility: Novartis Investigative Site
state: Florida
city: Tamarac
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Novartis Investigative Site
state: Florida
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Raleigh
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facility: Novartis Investigative Site
state: North Carolina
city: Shelby
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facility: Novartis Investigative Site
state: North Carolina
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Easley
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Gaffney
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Ninety Six
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Rock Hll
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Seneca
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facility: Novartis Investigative Site
state: South Carolina
city: Simpsonville
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facility: Novartis Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Union
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Amarillo
country: United States
facility: Novartis Investigative Site
state: Texas
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Beaumont
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Huntsville
country: United States
facility: Novartis Investigative Site
state: Texas
city: Waco
country: United States
facility: Novartis Investigative Site
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: