26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

Official title:

A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463567
• Other study ID #: CQAB149B2335S
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 19, 2007
• Last updated: July 22, 2011
• Start date: April 2007
• Est. completion date: August 2008

Study information

• Verified date: July 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Canada: Health CanadaItaly: Direzione Generale di Sanità Veterinaria e degli AlimentiKorea: Food and Drug AdministrationUnited States: Food and Drug AdministrationTaiwan: Department of HealthIndia: Institutional Review BoardSweden: Medical Products AgencyTurkey: Ministry of HealthVenezuela: Intituto Nacional de Higiene Rafael Rangel
• Study type: Interventional

Clinical Trial Summary

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 & 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2059
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male and female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure

• Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) Guidelines, 2005) and:

• Smoking history of at least 20 pack years

• Post-bronchodilator FEV1 < 80% and = 30% of the predicted normal value.

• Post-bronchodilator FEV1/FVC < 70% (Post refers to within 30 min of inhalation of 400 µg of salbutamol)

Exclusion Criteria:

• Pregnant or lactating females

• Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period

• Patients requiring long term oxygen therapy (> 15 h a day)

• Patients who have had a respiratory tract infection 6 weeks prior to V1 (with further criteria)

• Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis

• Patients with a history of asthma (with further criteria)

• Patients with Type I or uncontrolled Type II diabetes

• Patients with contraindications for tiotropium

• Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality

• Any patient with active cancer or a history of cancer with less than 5 years disease free survival time

• Patients with a history of long QT syndrome or whose QTc interval is prolonged

• Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structures

• Patients who have had treatment with the investigational drug (with further criteria)

• Patients who have had live attenuated vaccinations within 30 days prior to visit 1, or during run-in period

• Patients with known history of non compliance to medication

• Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Indacaterol
In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
• Formoterol (12 µg b.i.d.)
Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.
• Tiotropium (18 µg o.d.)
Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
• Placebo to Indacaterol
In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
• Placebo to Formoterol
In the morning and in the evening, placebo to formoterol delivered via Aerolizer.

Locations

Country	Name	City	State
Argentina	Novartis	Buenos Aires
Argentina	Novartis Investigator Site	Buenos Aires
Argentina	Novartis Investigator Site	Capital Federal
Argentina	Novartis Investigator Site	Santa Fe
Canada	Novartis Investigator Site	Ajax
Canada	Novartis Investigator Site	Calgary
Canada	Novartis Investigator Site	Chatham
Canada	Novartis Investigator Site	Gatineau
Canada	Novartis Investigator Site	Moncton
Canada	Novartis Investigator Site	Montreal
Canada	Novartis Investigator Site	Niagara Falls
Canada	Novartis Investigator Site	Ottawa
Canada	Novartis	Quebec
Canada	Novartis Investigator Site	Saskatoon
Canada	Novartis Investigator Site	Sherbrooke
Canada	Novartis Investigator Site	St John
Canada	Novartis Investigator Site	St John's
Canada	Novartis Investigator Site	St Romuald
Canada	Novartis Investigator Site	Ste-Foy
Canada	Novartis Investigator Site	Toronto
Canada	Novartis Investigator Site	Trois-Rivieres
Canada	Novartis Investigator Site	Vancouver
Canada	Novartis Investigator Site	Waterloo
Canada	Novartis Investigator Site	Windsor
Canada	Novartis Investigator Site	Winnipeg
Germany	Novartis Investigator Site	Augsburg
Germany	Novartis Investigator Site	Bad Segeberg
Germany	Novartis Investigator Site	Berlin
Germany	Novartis Investigator Site	Bielefeld
Germany	Novartis Investigator Site	Bonn
Germany	Novartis Investigator Site	Bruhl
Germany	Novartis Investigator Site	Dachau
Germany	Novartis	Fuerth
Germany	Novartis Investigator Site	Hamburg
Germany	Novartis Investigator Site	Hoyerswerda
Germany	Novartis Investigator Site	Kaufbeuren
Germany	Novartis Investigator Site	Landsberg
Germany	Novartis Investigator Site	Leipzig
Germany	Novartis Investigator Site	Mainz
Germany	Novartis Investigator Site	Muenchen
Germany	Novartis Investigator Site	Oranienburg
Germany	Novartis Investigator Site	Oschersleben
Germany	Novartis Investigator Site	Potsdam
Germany	Novartis Investigator Site	Ratingen
Germany	Novartis Investigator Site	Steinfurt
Germany	Novartis Investigator Site	Wuppertal
India	Novartis Investigator Site	Bangalore
India	Novartis Investigator Site	Banglore
India	Novartis Investigator Site	Caranazalem
India	Novartis Investigator Site	Chennai
India	Novartis Investigator Site	Coimbatore
India	Novartis Investigator Site	Hyderabaad
India	Novartis Investigator Site	Indore
India	Novartis Investigator Site	Jaipur
India	Novartis Investigator Site	Kolkatta
India	Novartis Investigator Site	Ludhiana
India	Novartis Investigator Site	Mumbai
India	Novartis Investigator Site	Trivandrum
Italy	Novartis Investigator Site	Bologna
Italy	Novartis Investigator Site	Busto Arsizio
Italy	Novartis Investigator Site	Catania
Italy	Novartis Investigator Site	Catanzaro
Italy	Novartis Investigator Site	Chioggia
Italy	Novartis Investigator Site	Crema
Italy	Novartis Investigator Site	Ferrara
Italy	Novartis Investigator Site	Firenze
Italy	Novartis Investigator Site	Genova
Italy	Novartis Investigator Site	Messina
Italy	Novartis	Milano
Italy	Novartis Investigator Site	Milano
Italy	Novartis Investigator Site	Pisa
Italy	Novartis Investigator Site	Roma
Italy	Novartis Investigator Site	Rozzano
Italy	Novartis Investigator Site	Siena
Korea, Republic of	Novartis Investigator Site	Bucheon
Korea, Republic of	Novartis Investigator Site	Busan
Korea, Republic of	Novartis Investigator Site	Chuncheon
Korea, Republic of	Novartis Investigator Site	Daegu
Korea, Republic of	Novartis Investigator Site	Kwangju
Korea, Republic of	Novartis	Seoul
Korea, Republic of	Novartis Investigator Site	Seoul
Korea, Republic of	Novartis Investigator Site	Suwon
Korea, Republic of	Novartis Investigator Site	Wonju
Puerto Rico	Novartis Investigator Site	Ponce
Spain	Novartis Investigator Site	Alicante
Spain	Novartis	Barcelona
Spain	Novartis Investigator Site	Barcelona
Spain	Novartis Investigator Site	Burgos
Spain	Novartis Investigator Site	Cadiz
Spain	Novartis Investigator Site	Calde Lugo
Spain	Novartis Investigator Site	Galdakano
Spain	Novartis Investigator Site	Gerona
Spain	Novartis Investigator Site	Gran Canaria
Spain	Novartis Investigator Site	La Coruna
Spain	Novartis Investigator Site	Madrid
Spain	Novartis Investigator Site	Malaga
Spain	Novartis Investigator Site	Orense
Spain	Novartis Investigator Site	Oviedo
Spain	Novartis Investigator Site	Palma de Mallorca
Spain	Novartis Investigator Site	Ponferrada
Spain	Novartis Investigator Site	Pontevedra
Spain	Novartis Investigator Site	Puerto de Sagunto
Spain	Novartis Investigator Site	Sevilla
Spain	Novartis Investigator Site	Valencia
Spain	Novartis Investigator Site	Vic
Spain	Novartis Investigator Site	Vila-Real
Spain	Novartis Investigator Site	Zaragoza
Sweden	Novartis	Goteborg
Sweden	Novartis Investigator Site	Jonkoping
Sweden	Novartis Investigator Site	Lidingo
Sweden	Novartis Investigator Site	Lulea
Sweden	Novartis Investigator Site	Lund
Taiwan	Novartis Investigator Site	Chiayi
Taiwan	Novartis Investigator Site	LinKou
Taiwan	Novartis Investigator Site	Taichung
Taiwan	Novartis	Taipei
Taiwan	Novartis Investigator Site	Taipei
Turkey	Novartis Investigator Site	Anakara
Turkey	Novartis	Istanbul
Turkey	Novartis Investigator Site	Izmir
Turkey	Novartis Investigator Site	Konya
Turkey	Novartis Investigator Site	Manisa
Turkey	Novartis Investigator Site	Mersin
Turkey	Novartis Investigator Site	Yenisehir
United States	Johnston Memorial Hospital Pulmonary Research	Abingdon	Virginia
United States	Pulmonary and Critical Care Services	Albany	New York
United States	PharmaTex Research LLC	Amarillo	Texas
United States	Community Hospital Anderson	Anderson	Indiana
United States	ClinSite, Inc	Ann Arbor	Michigan
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Crescent Medical Associates	Astoria	New York
United States	Neutrotrials Research Inc	Atlanta	Georgia
United States	Georgia Clinical Research	Austell	Georgia
United States	John Hopkins Asthma and Allergy Center	Baltimore	Maryland
United States	Allergy, Asthma, Immunology, Pharmaceutical Studies	Bangor	Maine
United States	Tri-State Medical Group	Beaver	Pennsylvania
United States	Madrona Medical Group - Clinical Research Dept.	Bellingham	Washington
United States	Primecare Physician Associates	Biddeford	Maine
United States	Montana Health Research Institute	Billings	Montana
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boulder Medical Center	Boulder	Colorado
United States	Miray Medical Center	Brockton	Massachusetts
United States	Novartis Investigator Site	Buena Park	California
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Hugh D. Durrence, MD, Family Medicine	Charleston	South Carolina
United States	Low County Lung and Critical Care, PA	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Sensenbrenner Primary Care	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Delaware Valley Clinical Research	Cherry Hill	New Jersey
United States	St. Luke's Cardio-Pulmonary Research	Chesterfield	Missouri
United States	University of Chicago Hospital	Chicago	Illinois
United States	Bernstein Clinical Research Centre	Cincinnati	Ohio
United States	Cincinnati VA Hospital	Cincinnati	Ohio
United States	Community Research Inc	Cincinnati	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Novartis Investigator Site	Clarkston	Michigan
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Metro Health Medical Center	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Vermont Lung Center	Colchester	Vermont
United States	University of Missouri - Columbia	Columbia	Missouri
United States	Novartis Investigator Site	Columbus	Ohio
United States	Novartis Investigator Site	Columbus	Ohio
United States	Ohio State University - Davis Heart and Lung Research Institute	Columbus	Ohio
United States	Remington-Davis Clinical Research	Columbus	Ohio
United States	Trinity Clinic - Corsicana	Corsicana	Texas
United States	Asthma and Allergy Associates	Cortland	New York
United States	New England Center for Clinical Research	Cranston	Rhode Island
United States	Novartis Investigator Site	Crescent Springs	Kentucky
United States	Partners in Clinical Research	Cumberland	Rhode Island
United States	Asthma & Allergy Research Associates	Dallas	Texas
United States	Pharmaceutical Research & Consulting, Inc	Dallas	Texas
United States	National Jewish Medical & Research Center	Denver	Colorado
United States	Harper University Hospital; Wayne State University	Detroit	Michigan
United States	USC Rancho Amigos Medical Center	Downey	California
United States	Pulmonary and Critical Care Associates, PA	East Brunswick	New Jersey
United States	Novartis Investigator Site	Easton	Pennsylvania
United States	Minnesota Lung Center	Edina	Minnesota
United States	Western Sky Medical Research	El Paso	Texas
United States	Asthma and Allergy Associates	Elmira	New York
United States	Encompass Clinical Research - North Coast	Encinitas	California
United States	Chest Diseases of Northwestern PA	Erie	Pennsylvania
United States	River Road Medical Group	Eugene	Oregon
United States	Merit Care Medical Group	Fargo	North Dakota
United States	Novartis Investigator Site	Flint	Michigan
United States	Northern Colorado Pulmonary Consultants, PC	Fort Collins	Colorado
United States	Texas Pulmonary & Critical Care	Ft. Worth	Texas
United States	California Research	Fullerton	California
United States	University of Florida Shands Hospital	Gainesville	Florida
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Med Plus South - Strand Family Practice	Garden City	South Carolina
United States	Pulmonary Associates, PA	Glendale	Arizona
United States	New West Physicians Clinical research	Golden	Colorado
United States	Novartis Investigator Site	Greenville	South Carolina
United States	Lovelace Scientific Resources, Inc.	Henderson	Nevada
United States	Pulmonary Medicine Associates PC	Homewood	Alabama
United States	*Private Practice*	Houston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	Houstons Veteran's Medical Center	Houston	Texas
United States	Allergy and Asthma Specialists Medical Group and research Center	Huntington Beach	California
United States	Dawes Fretzin Clinical Research Group LLC	Indianapolis	Indiana
United States	Iowa Clinical Research Corporation	Iowa City	Iowa
United States	University of Iowa	Iowa City	Iowa
United States	Shands Jacksonville Medical Center	Jacksonville	Florida
United States	Jasper Summit Research	Jasper	Alabama
United States	MultiSpeciality Clinical Research	Johnson City	Tennessee
United States	Novartis Investigator Site	Kalispell	Montana
United States	Kansas City University of Medicine and Biosciences	Kansas City	Missouri
United States	University of Missouri KC/ Truman Medical	Kansas City	Missouri
United States	West Houston Allergy and Asthma, PA	Katy	Texas
United States	Holston Medical Group	Kingsport	Tennessee
United States	Volunteer Research Center	Knoxville	Tennessee
United States	Gulf Coast Research, LLC	Lafayette	Louisiana
United States	Innovative Research of West Florida	Largo	Florida
United States	Clinical Research Center of NV	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Kentucky Medical research Center	Lexington	Kentucky
United States	University of Kentucky Chandler Medical Center	Lexington	Kentucky
United States	Somnos Laboratories, Inc	Lincoln	Nebraska
United States	Pulmonary Respiratory Institute of Southwest Michigan	Livonia	Michigan
United States	Interlink Research Institute	Los Alamitos	California
United States	Allergy Research Foundation, Inc	Los Angeles	California
United States	David Geffen UCLA School of Medicine	Los Angeles	California
United States	Novartis Investigator Site	Los Angeles	California
United States	Southern California Institute for Respiratory Diseases	Los Angeles	California
United States	Family Asthma and Allergy Research Associates	Louisville	Kentucky
United States	Lynchburg Pulmonary Associates	Lynchburg	Virginia
United States	Marietta Pulmonary Medicine	Marietta	Georgia
United States	Novartis Investigator Site	Marion	Ohio
United States	Nassau Chest Physicians, PC	Massapequa	New York
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Oregon Clinical Research Associates	Medford	Oregon
United States	Rx R&D	Metaire	Louisiana
United States	Elite Research Institute	Miami	Florida
United States	University of Miami School of Medicine	Miami	Florida
United States	Novartis Investigator Site	Milwaukee	Wisconsin
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Minnesota Lung Center	Minneapolis	Minnesota
United States	Novartis Investigator Site	Minneapolis	Minnesota
United States	Novartis Investigator Site	Missoula	Montana
United States	Pulmonary Associate of Mobile, PC	Mobile	Alabama
United States	Dickson Family Medicine Group, PC	Nashville	Tennessee
United States	Novartis Investigator Site	Nashville	Tennessee
United States	Central Texas Health Research	New Braunfels	Texas
United States	North Shore University Hospital	New Hyde Park	New York
United States	LSU Health Sciences Center/LSU School of Medicine	New Orleans	Louisiana
United States	New Orleans Center for Clinical Research	New Orleans	Louisiana
United States	Heartland Medical, P.C	New Tazewell	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	New York Pulmonary Associates, PC	New York	New York
United States	Weill Medical College of Cornell University	New York	New York
United States	Lung Health & Sleep Enhancement Center	Newark	Delaware
United States	Novartis Investigator Site	Newark	New Jersey
United States	Sneeze, Wheeze & Itch Associates, LLC	Normal	Illinois
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Southern Illinois Clinical Research Center	O'Fallon	Illinois
United States	Lynne Health Science Institute	Oklahoma City	Oklahoma
United States	Oklahoma Allergy and Asthma Clinic	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Creighton University Centre for Allergy, Asthma & Immunology	Omaha	Nebraska
United States	Creigton University	Omaha	Nebraska
United States	Heartland Clinical Research, Inc	Omaha	Nebraska
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	Midwest Allergy and Asthma Clinic	Omaha	Nebraska
United States	Omaha VA Medical Center	Omaha	Nebraska
United States	Quality Clinical Research	Omaha	Nebraska
United States	University of Nebraska Medical Center - Pulmonary Research	Omaha	Nebraska
United States	Advance Clinical Research Institute	Orange	California
United States	California Allergy & Asthma Medical Group	Palmdale	California
United States	The Asthma & Allergy Center, PC	Papillion	Nebraska
United States	Novartis Investigator Site	Pembroke Pines	Florida
United States	Emerald Coast Clinical Research, LLC	Pensacola	Florida
United States	Integrity Research	Pensacola	Florida
United States	Pensacola Research Consultants	Pensacola	Florida
United States	Asthma Allergy &Pulmonary Associates, PC	Philadelphia	Pennsylvania
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Novartis Investigator Site	Philadelphia	Pennsylvania
United States	Novartis Investigator Site	Philadelphia	Pennsylvania
United States	Pulmonary Associates, PA	Phoenix	Arizona
United States	Novartis Investigator Site	Pine Bluff	Arkansas
United States	Pittsburgh Pulmonary Associates	Pittsburgh	Pennsylvania
United States	South Hills Pulmonary Associates	Pittsburgh	Pennsylvania
United States	Novartis Investigator Site	Port Huron	Michigan
United States	Allergy Associates Research Center	Portland	Oregon
United States	Novartis Investigator Site	Portland	Oregon
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Novartis Investigator Site	Richmond	Virginia
United States	Novartis Investigator Site	River Forest	Illinois
United States	Intergrated Research Group	Riverside	California
United States	AAIR research Centre	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Brevard Pulmonary Specialists	Rockledge	Florida
United States	Synergy Medical Education Alliance	Saginaw	Michigan
United States	Allergy and Asthma Research Center, PA	San Antonio	Texas
United States	Audie L. Murphy VA Hospital	San Antonio	Texas
United States	Diagnostics Research Group	San Antonio	Texas
United States	Quality Assurance Research Centre	San Antonio	Texas
United States	Wellmed Clinical Research	San Antonio	Texas
United States	Allergy & Asthma Associates of Santa Clara Res. Center	San Jose	California
United States	Asthma & Allergy Research Center	Sarasota	Florida
United States	Arizona Pulmonary Specialists, LTD	Scottsdale	Arizona
United States	Novartis Investigative Center	Scottsdale	Arizona
United States	Greater Los Angeles Healthcare System	Sepulveda	California
United States	Heart of America Research Institute	Shawnee Mission	Kansas
United States	Novartis Investigator Site	Shelby	North Carolina
United States	Louisiana Health Sciences Center	Shreveport	Louisiana
United States	Northshore Research Associates	Slidell	Louisiana
United States	South Bend Clinic	South Bend	Indiana
United States	South Miami Clinical Research, LLC	South Miami	Florida
United States	Spartanburg Pharmaceutical Research	Spartanburg	South Carolina
United States	Pulmonary and Research Associates	Spokane	Washington
United States	William L. Gray Research	Spokane	Washington
United States	Encompass Clinical Research	Spring Valley	California
United States	The Clinical Research Centre	St, Louis	Missouri
United States	Midwest Chest Consultants	St. Charles	Missouri
United States	Washington U School of Medicine, Center for Clinical Studies	St. Louis	Missouri
United States	Bensch Clinical Research Associates	Stockton	California
United States	Pulmonary and Allergy Associates, PA	Summit	New Jersey
United States	John Winder Associates	Sylvania	Ohio
United States	Madigan Army medical Center / Dept. of Army	Tacoma	Washington
United States	Pulmonary Consultants, PLLC	Tacoma	Washington
United States	Central Medical Group, PA	Tamarac	Florida
United States	Clireco, Inc	Tamarac	Florida
United States	Novartis Investigator Site	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Premiere Pharmaceutical Research, LLC	Tempe	Arizona
United States	Advanced Health Care Specialists	Thornville	Ohio
United States	The University of Toledo	Toledo	Ohio
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	Peninsula Pulmonary Medical Associates	Torrance	California
United States	Novartis Investigator Site	Troy	Michigan
United States	Canyon Clinical Research, LLC	Tucson	Arizona
United States	SAVAHSC / Pulmonary Section	Tucson	Arizona
United States	Healthcare Research Consultants, Inc	Tulsa	Oklahoma
United States	Palmetto Pulmonary Medicine, PA - Sleep Disorders Lab	Varnville	South Carolina
United States	Progressive Clinical Research	Vista	California
United States	Allergy and Asthma Clinical Research Inc	Walnut Creek	California
United States	Rocky Mountain Center for Clinical Research	Wheat Ridge	Colorado
United States	Western States Clinical Research	Wheat Ridge	Colorado
United States	Cloverdale Research Facility	Winston Salem	North Carolina
United States	Fallon Clinic at Worcester Medical Center	Worcester	Massachusetts
United States	Pharmacotherapy Research Associates, Inc	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Germany,  India,  Italy,  Korea, Republic of,  Puerto Rico,  Spain,  Sweden,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment	FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 h 10 min and the 23 h 45 min post dose values. Mixed model used baseline FEV1, FEV1 prior to and 30 minutes post inhalation of salbutamol/albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariates.	after 12 weeks of treatment	No
Secondary	The Percentage of "Days of Poor Control" Reported Over the 26 Week Treatment Period	A Chronic Obstructive Pulmonary Disease (COPD) "day of poor control" was defined as any day in the participant's diary with a score =2 (moderate or severe) for at least 2 of 5 symptoms (cough, wheeze, production of sputum, color of sputum, breathlessness). Score for each symptom ranges from 0-3; a higher number indicates a more severe symptom. The model contained baseline percentage of "days of poor control" as well as FEV1 reversibility components as covariates.	up to 26 weeks	No