Clinical trial NCT01697696: Long Term Safety Study of NVA237 vs QAB149 in COPD Patients
Official title: A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD, NVA237, QAB149, glycopyrronium bromide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-10-02
Enrollment: 511
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 purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients with COPD according to GOLD 2011 who have signed informed consent.
2. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.
3. Current or ex-smokers with a smoking history of at least 10 pack years
4. Patients with a mMRC score of at least 2 at run-in.

Exclusion Criteria:

1. Patients contraindicated for muscarinic antagonist agents and beta-2 agonists
2. Patients with a history of malignancy of any organ system, treated or untreated, within the last five years
3. Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention
4. Patients who had a COPD exacerbation within 6 weeks prior to screening.
5. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
6. Patients with a history of asthma.
7. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age.
8. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in
9. Patients with concomitant pulmonary disease
10. Patients with a history of certain cardiovascular co-morbid conditions
11. Patients with a diagnosis of alpha-1 anti-trypsin deficiency
12. Patients with active pulmonary tuberculosis
13. Patients in the active phase of a pulmonary rehabilitation programme
14. Other protocol-defined inclusion / exclusion criteria may apply

Primary outcomes:
measure: Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to Treatment Discontinuation
timeFrame: 52 Weeks
measure: Change From Baseline in Mean Forced Expiratory Volume (Average of the Two FEV1 Measurements 45 and 15 Minutes Pre-dose) in One Second at Week 52
timeFrame: -45 min and -15 minutes baseline and at Week 52
measure: Change From Baseline in Pre-dose Forced Expiratory Volume (FEV1) in One Second at All Post Baseline Timepoints
timeFrame: -45 min and -15 minutes baseline and at Week 52
measure: Change From Baseline in Pre-dose Forced Vital Capacity (FVC) at All Post-baseline Timepoints
timeFrame: -45 min and -15 minutes baseline and at Week 52
measure: Change From Baseline in COPD Symptoms
timeFrame: 52 weeks
measure: Change From Baseline in COPD Symptoms
timeFrame: 52 weeks
measure: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication
timeFrame: 52 weeks
measure: Time to First COPD Exacerbation (Moderate or Severe).
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Gulf Shores
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Riverside
country: United States
facility: Novartis Investigative Site
state: California
city: Fort Collins
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Wheat Ridge
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Glastonbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Stamford
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Waterbury
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Novartis Investigative Site
state: Florida
city: Hialeah
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Oakland Park
country: United States
facility: Novartis Investigative Site
state: Florida
city: Pensacola
country: United States
facility: Novartis Investigative Site
state: Florida
city: Couer D'Alene
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Newburgh
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Topeka
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Florence
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Madisonville
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Opelousas
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Biddeford
country: United States
facility: Novartis Investigative Site
state: Maine
city: Worchester
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Edina
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Fridley
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Fremont
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Henderson
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Lebanon
country: United States
facility: Novartis Investigative Site
state: New Hampshire
city: Calabash
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Tabor City
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Marion
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Zanesville
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Eugene
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Warwick
country: United States
facility: Novartis Investigative Site
state: Rhode Island
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: Greenville
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Greer
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: N. Myrtle Beach
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Boerne
country: United States
facility: Novartis Investigative Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Kingwood
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: White River Junction
country: United States
facility: Novartis Investigative Site
state: Vermont
city: Burke
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Fredericksburg
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Manassas
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Oregon
country: United States
facility: Novartis Investigative Site
state: Wisconsin
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Mahler DA, Gifford AH, Satti A, Jessop N, Eckert JH, D'Andrea P, Mota F, Banerjee R. Long-term safety of glycopyrrolate: A randomized study in patients with moderate-to-severe COPD (GEM3). Respir Med. 2016 Jun;115:39-45. doi: 10.1016/j.rmed.2016.03.015. Epub 2016 Mar 22.