Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

COPD Clinical Trial

Official title:

A 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00677807
• Other study ID #: CQAB149B2335SE
• Secondary ID: 2008-000663-42
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2008
• Last updated: August 18, 2011
• Start date: May 2008
• Est. completion date: March 2009

Study information

• Verified date: August 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesCanada: Health CanadaArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaIndia: Institutional Review BoardItaly: The Italian Medicines AgencySpain: Spanish Agency of MedicinesSweden: Medical Products AgencyTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 415
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).

• In addition the following inclusion/exclusion criteria specified below must be met.

1. Patients must complete Stage 2 of the core study B2335S (NCT00463567).

2. Written informed consent to participate in the extension must be obtained.

3. Patients must be able to comply with all study requirements.

Exclusion Criteria:

• Patients who were randomized to open-label tiotropium in Study B2335S.

• Patients who participated in Stage 1 of the core study (B2335S).

• Patients discontinued irrespective of the reason from Stage 2 of the core study.

• Patients who fail to comply with the core protocol requirements and procedures.

• Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.

• Patients who in the Investigator's opinion should not participate in the extension study.

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Indacaterol
Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
• Placebo
Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)

Locations

Country	Name	City	State
Argentina	Novartis Investigative site	Buenos Aires
Argentina	Novartis Investigative site	Rosario
Canada	Novartis Investigative site	Ajax
Canada	Novartis Investigative site	Calgary
Canada	Novartis Investigative site	Gatineau
Canada	Novartis Investigative site	Moncton
Canada	Novartis Investigative site	Montreal
Canada	Novartis Investigative site	Niagara Falls
Canada	Novartis Investigative site	Ottawa
Canada	Novartis Investigative site	Quebec
Canada	Novartis Investigative site	Saskatoon
Canada	Novartis Investigative site	Sherbrooke
Canada	Novartis Investigative site	St-Romuald
Canada	Novartis Investigative site	St. John
Canada	Novartis Investigative site	St. John's
Canada	Novartis Investigative site	Toronto
Canada	Novartis Investigative site	Trois-Rivières
Canada	Novartis Investigative site	Vancouver
Canada	Novartis Investigative site	Windsor
Canada	Novartis Investigative site	Winnipeg
Germany	Novartis Investigative site	Augsburg
Germany	Novartis Investigative site	Bad Segeberg
Germany	Novartis Investigative site	Berlin
Germany	Novartis Investigative site	Bielefeld
Germany	Novartis Investigative site	Bonn
Germany	Novartis Investigative site	Dachau
Germany	Novartis Investigative site	Hamburg
Germany	Novartis Investigative site	Hoyerswerda
Germany	Novartis Investigative site	Kaufbeuren
Germany	Novartis Investigative site	Landsberg
Germany	Novartis Investigative site	Leipzig
Germany	Novartis Investigative site	Mainz
Germany	Novartis Investigative site	Muenchen
Germany	Novartis Investigative site	Oranienburg
Germany	Novartis Investigative site	Oschersleben
Germany	Novartis Investigative site	Potsdam
Germany	Novartis Investigative site	Ratingen
Germany	Novartis Investigative site	Steinfurt-Borghorst
India	Novartis Investigator Site	Bangalore
India	Novartis Investigative Site	Chennai
India	Novartis Investigative Site	Coimbatore
India	Novartis Investigator Site	Coimbatore
India	Novartis Investigator Site	Hyderabaad
India	Novartis Investigator Site	Indore
India	Novartis Investigator Site	Jaipur
India	Novartis Investigator Site	Kolkata
India	Novartis Investigator Site	Ludhiana
India	Novartis Investigative Site	Mumbai
India	Novartis Investigator Site	Panjim
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	Crema
Italy	Novartis Investigator Site	Ferrara
Italy	Novartis Investigator Site	Firenze
Italy	Novartis Investigator Site	Messina
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
Italy	Novartis Investigator Site	Sottomarina
Spain	Novartis Investigator Site	Alicante
Spain	Novartis Investigator Site	Alzira
Spain	Novartis Investigator Site	Barcelona
Spain	Novartis Investigator Site	Burgos
Spain	Novartis Investigator Site	Cordoba
Spain	Novartis Investigator Site	Girona
Spain	Novartis Investigator Site	Gladakano
Spain	Novartis Investigator Site	Jerez de Frontera
Spain	Novartis Investigator Site	La Coruna
Spain	Novartis Investigator Site	Las Palmas de Gran Canaria
Spain	Novartis Investigator Site	Las Palmas de Gran Canarias
Spain	Novartis Investigator Site	Lugo
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 Investigative Site	Pontevedra
Spain	Novartis Investigator Site	Puerto de Sagunto
Spain	Novartis Investigative Site	Sevilla
Spain	Novartis Investigator Site	Valencia
Spain	Novartis Investigator Site	Vic
Spain	Novartis Investigator Site	Vila-real
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Goteborg
Sweden	Novartis Investigator Site	Jonkoping
Sweden	Novartis Investigative Site	Lidingo
Sweden	Novartis Investigative Site	Lulea
Sweden	Novartis Investigator Site	Lulea
Sweden	Novartis Investigator Site	Lund
Turkey	Novartis Investigative Site	Kartal/Istanbul
Turkey	Novartis Investigator Site	Mersin
Turkey	Novartis Investigator Site	Yenisehir/Izmir
United States	Novartis Investigative Site	Abingdon	Virginia
United States	Novartis Investigative Site	Atlanta	Georgia
United States	Novartis Investigative Site	Bellingham	Washington
United States	Novartis Investigative Site	Biddeford	Maine
United States	Novartis Investigative Site	Billings	Montana
United States	Novartis Investigative Site	Charlotte	North Carolina
United States	Novartis Investigative Site	Chesterfield	Missouri
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investgative Site	Clarkston	Michigan
United States	Novartis Investigative Site	Clearwater	Florida
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Columbia	Missouri
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Columbus	Ohio
United States	Novartis Investigative Site	Corsicana	Texas
United States	Novartis Investigative site	Cranston	Rhode Island
United States	Novartis Investigative Site	Crescent Springs	Kentucky
United States	Novartis Investigative Site	Cumberland	Rhode Island
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative site	El Paso	Texas
United States	Novartis Investigative Site	Elmira	New York
United States	Novartis Investigative Site	Encinitas	California
United States	Novartis Investigative Site	Erie	Pennsylvania
United States	Novartis Investigative Site	Eugene	Oregon
United States	Novartis Investigative Site	Fargo	North Dakota
United States	Novartis Investigative Site	Flint	Michigan
United States	Novartis Investigative site	Fort Collins	Colorado
United States	Novartis Investigative Site	Fort Worth	Texas
United States	Novartis Investigative SIte	Fullerton	California
United States	Novartis Investigative site	Golden	Colorado
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative site	Henderson	Nevada
United States	Novartis Investigative Site	Homewood	Alabama
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Iowa City	Iowa
United States	Novartis Investigative Site	Iowa City	Iowa
United States	Novartis Investigative Site	Jasper	Alabama
United States	Novartis Investigative Site	Johnson City	Tennessee
United States	Novartis Investigative Site	Kalispell	Montana
United States	Novartis Investigative Site	Kansas City	Missouri
United States	Novartis Investigative Site	Lafayette	Louisiana
United States	Novartis Investigative Site	Largo	Florida
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Lincoln	Nebraska
United States	Novartis Investigative Site	Livonia	Michigan
United States	Novartis Investigative site	Lynchburg	Virginia
United States	Novartis Investigative Site	Marietta	Georgia
United States	Novartis Investigative Site	Marion	Ohio
United States	Novartis Investigative Site	Medford	Oregon
United States	Novartis Investigative Site	Metaire	Louisiana
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative site	New Orleans	Louisiana
United States	Novartis Investigative site	New York	New York
United States	Novartis Investigative Site	Normal	Illinois
United States	Novartis Investigative Site	O'Fallon	Illinois
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Omaha	Nebraska
United States	Novartis Investigative Site	Orange	California
United States	Novartis Investigative Site	Papillion	Nebraska
United States	Novartis Investigative Site	Pensacola	Florida
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Pine Bluff	Arkansas
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	River Forest	Illinois
United States	Novartis Investigative Site	Riverside	California
United States	Novartis Investigative Site	Rochester	Minnesota
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative Site	Rockledge	Florida
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	Shelby	North Carolina
United States	Novartis Investigative Site	South Miami	Florida
United States	Novartis Investigative site	Spokane	Washington
United States	Novartis Investigative Site	Spring Valley	California
United States	Novartis Investigative Site	St Louis	Missouri
United States	Novartis Investigative site	Summit	New Jersey
United States	Novartis Investigative Site	Sylvania	Ohio
United States	Novartis Investigative Site	Tamarac	Florida
United States	Novartis Investigative Site	Tampa	Florida
United States	Novartis Investigative Site	Thornville	Ohio
United States	Novartis Investigative Site	Topeka	Kansas
United States	Novartis Investigative site	Troy	Michigan
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Wheat Ridge	Colorado
United States	Novartis Investigative Site	Winston Salem	North Carolina
United States	Novartis Investigative Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Germany,  India,  Italy,  Spain,  Sweden,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo	The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment.; Low Pulse Rate was defined as a pulse rate: <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm.; High Pulse Rate was defined as a pulse rate: >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm.	Up to 52 weeks	Yes
Primary	The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo	The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.; A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg.; A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg.	Up to 52 weeks	Yes
Primary	The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo	The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment.; A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg.; A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg.	Up to 52 weeks	Yes
Primary	The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo	The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline.; The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms).; Notable QTC interval= >450 ms for males and >470 ms for females. The maximum QTC increase from pre to post dose at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms.	Up to 52 weeks	Yes
Primary	Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52	The least squares mean of the serum potassium in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate.	Weeks 12, 26, 36, 44 and 52	No
Primary	Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52	The least squares mean of the blood glucose in mmol/L at weeks 12, 26, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate.	Weeks 12, 26, 36, 44 and 52	No
Secondary	Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment	Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose at week 52. The mixed model used baseline FEV1 as well as FEV1 reversibility components as covariates.	Week 52	No
Secondary	Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52	The least squares mean of the SGRQ total score at weeks 36, 44 and 52. Mixed model used for analysis used baseline SGRQ total score as well as FEV1 reversibility components as covariates.; SGRQ is a health related quality of life questionnaire consisting of 50 items in three domains: symptoms, activity and impacts. The total score is 0 to 100 with a higher score indicating poorer health. A difference from placebo of -4 in the least squares mean SGRQ total score is considered clinically relevant.	Weeks 36, 44 and 52	No