26 Week Efficacy, Safety and Tolerability Study of Indaca... | NCT00463567 | Trialant
NCT00463567
Sponsor
Novartis
Status
Completed
Last Update Posted
Aug 18, 2011Estimated
Enrollment
2,059Actual
Phase
Phase 2Phase 3
Conditions
Pulmonary Disease, Chronic Obstructive
COPD
Lung Diseases, Obstructive
Interventions
Indacaterol
Formoterol (12 µg b.i.d.)
Tiotropium (18 µg o.d.)
Placebo to Indacaterol
Placebo to Formoterol
Countries
United States
Argentina
Canada
Germany
India
Italy
Puerto Rico
South Korea
Spain
Sweden
Taiwan
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT00463567
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CQAB149B2335S
Secondary IDs
Not provided
Brief Title
26 Week Efficacy, Safety and Tolerability Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jul 2011
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2007
Primary Completion Date
Aug 2008Actual
Completion Date
Aug 2008Actual
First Submitted Date
Apr 19, 2007
First Submission Date that Met QC Criteria
Apr 19, 2007
First Posted Date
Apr 20, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 22, 2011
Results First Submitted that Met QC Criteria
Jul 22, 2011
Results First Posted Date
Aug 18, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 22, 2011
Last Update Posted Date
Aug 18, 2011Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
NovartisINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief 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
Detailed Description
Not provided
Conditions Module
Conditions
Pulmonary Disease, Chronic Obstructive
COPD
Lung Diseases, Obstructive
Keywords
indacaterol
long acting beta-2 agonist
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,059Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Indacaterol 150 µg (Continued Into Stage 2)
Experimental
In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Drug: Indacaterol
Drug: Placebo to Indacaterol
Drug: Placebo to Formoterol
Indacaterol 300 µg (Continued Into Stage 2)
Experimental
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Drug: Indacaterol
Drug: Placebo to Indacaterol
Drug: Placebo to Formoterol
Tiotropium 18 µg (Continued Into Stage 2)
Active Comparator
Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Indacaterol
Drug
In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
Indacaterol 150 µg (Continued Into Stage 2)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Measure
Description
Time Frame
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment
Interim Analysis: Stage 1.
Spirometry was 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.
Eligibility Module
Eligibility Criteria
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
Jones PW, Donohue JF, Nedelman J, Pascoe S, Pinault G, Lassen C. Correlating changes in lung function with patient outcomes in chronic obstructive pulmonary disease: a pooled analysis. Respir Res. 2011 Dec 29;12(1):161. doi: 10.1186/1465-9921-12-161.
Yelensky R, Li Y, Lewitzky S, Leroy E, Hurwitz C, Rodman D, Trifilieff A, Paulding CA. A pharmacogenetic study of ADRB2 polymorphisms and indacaterol response in COPD patients. Pharmacogenomics J. 2012 Dec;12(6):484-8. doi: 10.1038/tpj.2011.54. Epub 2011 Dec 13.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This study consisted of two stages: a dose selection stage (Stage 1, 2 weeks) from which 2 out of 4 Indacaterol doses were selected following interim analysis to continue into Stage 2 for comparisons of efficacy, safety, and tolerability for total treatment of up to 26 weeks.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Indacaterol 150 µg (Continued Into Stage 2)
In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Drug: Placebo to Indacaterol
Drug: Placebo to Formoterol
Indacaterol 75 µg (Not Continued into Stage 2)
Experimental
In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Drug: Indacaterol
Drug: Placebo to Indacaterol
Drug: Placebo to Formoterol
Indacaterol 600 µg (Not Continued Into Stage 2)
Experimental
In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Drug: Indacaterol
Drug: Placebo to Formoterol
Formoterol 12 µg (Not Continued Into Stage 2)
Active Comparator
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Drug: Formoterol (12 µg b.i.d.)
Drug: Placebo to Indacaterol
Indacaterol 300 µg (Continued Into Stage 2)
Indacaterol 600 µg (Not Continued Into Stage 2)
Indacaterol 75 µg (Not Continued into Stage 2)
Formoterol (12 µg b.i.d.)
Drug
Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.
Formoterol 12 µg (Not Continued Into Stage 2)
Tiotropium (18 µg o.d.)
Drug
Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.
Tiotropium 18 µg (Continued Into Stage 2)
Placebo to Indacaterol
Drug
In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).
Formoterol 12 µg (Not Continued Into Stage 2)
Indacaterol 150 µg (Continued Into Stage 2)
Indacaterol 300 µg (Continued Into Stage 2)
Indacaterol 75 µg (Not Continued into Stage 2)
Placebo (Continued Into Stage 2)
Placebo to Formoterol
Drug
In the morning and in the evening, placebo to formoterol delivered via Aerolizer.
Indacaterol 150 µg (Continued Into Stage 2)
Indacaterol 300 µg (Continued Into Stage 2)
Indacaterol 600 µg (Not Continued Into Stage 2)
Indacaterol 75 µg (Not Continued into Stage 2)
Placebo (Continued Into Stage 2)
up to 26 weeks
Day 15, After 2 Weeks of treatment in Stage 1
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment
Interim Analysis: Stage 1.
Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. 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.
Day 14, After 2 Weeks of treatment in Stage 1
Birmingham
Alabama
35249
United States
Pulmonary Medicine Associates PC
Homewood
Alabama
35209
United States
Jasper Summit Research
Jasper
Alabama
35501
United States
Pulmonary Associate of Mobile, PC
Mobile
Alabama
36608
United States
Pulmonary Associates, PA
Glendale
Arizona
85306
United States
Pulmonary Associates, PA
Phoenix
Arizona
85006
United States
Novartis Investigative Center
Scottsdale
Arizona
85255
United States
Arizona Pulmonary Specialists, LTD
Scottsdale
Arizona
85258
United States
Premiere Pharmaceutical Research, LLC
Tempe
Arizona
85282
United States
Canyon Clinical Research, LLC
Tucson
Arizona
85712
United States
SAVAHSC / Pulmonary Section
Tucson
Arizona
85723
United States
Novartis Investigator Site
Pine Bluff
Arkansas
71603
United States
Novartis Investigator Site
Buena Park
California
90620
United States
USC Rancho Amigos Medical Center
Downey
California
90242
United States
Encompass Clinical Research - North Coast
Encinitas
California
92024
United States
California Research
Fullerton
California
92835
United States
Allergy and Asthma Specialists Medical Group and research Center
Huntington Beach
California
92647
United States
Interlink Research Institute
Los Alamitos
California
90720
United States
Allergy Research Foundation, Inc
Los Angeles
California
90025
United States
Novartis Investigator Site
Los Angeles
California
90033
United States
Southern California Institute for Respiratory Diseases
Los Angeles
California
90048
United States
David Geffen UCLA School of Medicine
Los Angeles
California
90095
United States
Advance Clinical Research Institute
Orange
California
92869
United States
California Allergy & Asthma Medical Group
Palmdale
California
93551
United States
Intergrated Research Group
Riverside
California
92506
United States
Allergy & Asthma Associates of Santa Clara Res. Center
Jones PW, Mahler DA, Gale R, Owen R, Kramer B. Profiling the effects of indacaterol on dyspnoea and health status in patients with COPD. Respir Med. 2011 Jun;105(6):892-9. doi: 10.1016/j.rmed.2011.02.013. Epub 2011 Mar 11.
Worth H, Chung KF, Felser JM, Hu H, Rueegg P. Cardio- and cerebrovascular safety of indacaterol vs formoterol, salmeterol, tiotropium and placebo in COPD. Respir Med. 2011 Apr;105(4):571-9. doi: 10.1016/j.rmed.2010.11.027. Epub 2011 Jan 11.
Donohue JF, Fogarty C, Lotvall J, Mahler DA, Worth H, Yorgancioglu A, Iqbal A, Swales J, Owen R, Higgins M, Kramer B; INHANCE Study Investigators. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium. Am J Respir Crit Care Med. 2010 Jul 15;182(2):155-62. doi: 10.1164/rccm.200910-1500OC. Epub 2010 May 12.
FG001
Indacaterol 300 µg (Continued Into Stage 2)
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
FG002
Tiotropium (Continued Into Stage 2)
Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
FG003
Placebo (Continued Into Stage 2)
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
FG004
Indacaterol 75 µg (Not Continued Into Stage 2)
In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
FG005
Indacaterol 600 µg (Not Continued Into Stage 2)
In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
FG006
Formoterol 12 µg (Not Continued Into Stage 2)
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
FG000420 subjectsRandomized Participants
FG001418 subjects
FG002420 subjects
FG003425 subjects
FG004130 subjects
FG005123 subjects
FG006123 subjects
Safety Population: Received Study Drug
FG000416 subjects
FG001416 subjects
FG002415 subjects
FG003418 subjects
FG004127 subjects'Completed' indicates the number of patients in the interim analysis.
FG005122 subjects'Completed' indicates the number of patients in the interim analysis.
FG006122 subjects'Completed' indicates the number of patients in the interim analysis.
COMPLETED
FG000325 subjects
FG001341 subjects
FG002331 subjects
FG003294 subjects
FG004107 subjects
FG005102 subjects
FG006112 subjects
NOT COMPLETED
FG00095 subjects
FG00177 subjects
FG00289 subjects
FG003131 subjects
FG00423 subjects
FG00521 subjects
FG00611 subjects
Type
Comment
Reasons
Adverse Event
FG00029 subjects
FG00126 subjects
FG00217 subjects
FG00346 subjects
FG00410 subjects
FG00510 subjects
FG0064 subjects
Withdrawal by Subject
FG00029 subjects
FG00122 subjects
FG00220 subjects
FG00337 subjects
FG004
Protocol Deviation
FG00013 subjects
FG0019 subjects
FG00214 subjects
FG00311 subjects
FG004
Lost to Follow-up
FG00012 subjects
FG0016 subjects
FG00213 subjects
FG0038 subjects
FG004
Administrative problems
FG0005 subjects
FG0013 subjects
FG0026 subjects
FG0039 subjects
FG004
Lack of Efficacy
FG0004 subjects
FG0019 subjects
FG0029 subjects
FG00317 subjects
FG004
Abnormal lab value(s)
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Abnormal test procedure result(s)
FG0001 subjects
FG0011 subjects
FG0026 subjects
FG0032 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Indacaterol 150 µg (Continued Into Stage 2)
In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
BG001
Indacaterol 300 µg (Continued Into Stage 2)
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
BG002
Tiotropium 18 µg (Continued Into Stage 2)
Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
BG003
Placebo (Continued Into Stage 2)
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
BG004
Indacaterol 75 µg (Not Continued Into Stage 2)
In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
BG005
Indacaterol 600 µg (Not Continued Into Stage 2)
In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
BG006
Formoterol 12 µg (Not Continued Into Stage 2)
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000416
BG001416
BG002415
BG003418
BG004127
BG005122
BG006122
BG0072036
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Baseline Measures were based on the Safety Population that included all participants who received at least one dose of study drug.
Number
participants
Title
Denominators
Categories
Between 40 and 64 years
Title
Measurements
BG000214
BG001230
BG002215
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000157
BG001153
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
Participants from the Intent to Treat Population of Stage 2 of the study who received at least one dose of study drug and for whom data was available for FEV1 at 12 weeks. Imputed with last observation carried forward.
Posted
Least Squares Mean
Standard Error
Liters
after 12 weeks of treatment
ID
Title
Description
OG000
Indacaterol 150 µg (Continued Into Stage 2)
In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG001
Indacaterol 300 µg (Continued Into Stage 2)
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG002
Tiotropium 18 µg (Continued Into Stage 2)
Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG003
Placebo (Continued Into Stage 2)
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Units
Counts
Participants
OG000389
OG001389
OG002393
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.46± 0.015
OG0011.46± 0.015
OG0021.42± 0.015
OG003
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.
Intent to Treat population consisting of all participants in Stage 2 of the study who received at least one dose of study drug. Eligible participants for the analysis were those with ≥7 evaluable diary days in the baseline period and ≥30% evaluable diary days (at least 20 days) in total.
Posted
Least Squares Mean
Standard Error
Percentage of days
up to 26 weeks
ID
Title
Description
OG000
Indacaterol 150 µg (Continued Into Stage 2)
In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG001
Other Pre-specified
Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 2 Weeks of Treatment
Interim Analysis: Stage 1.
Spirometry was 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.
Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for Trough FEV1 at Day 15. Missing data were imputed using last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
Liters
Day 15, After 2 Weeks of treatment in Stage 1
ID
Title
Description
OG000
Indacaterol 150 µg
In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG001
Indacaterol 300 µg
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Other Pre-specified
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 1 Hour to 4 Hour Post Morning Dose After 2 Weeks of Treatment
Interim Analysis: Stage 1.
Spirometry was conducted according to internationally accepted standards. Standardized with respect to time (AUC 1h-4h) for FEV1 measurements taken from 1 hour to 4 hour post morning dose on Day 14. Standardized FEV1 AUC was calculated by the trapezoidal rule. 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.
Interim Intent-to-treat (ITT) population included participants in Stage 1 of the study who received at least one dose of study drug and for whom data were available for AUC 1h-4h FEV1 at Day 14. Missing data were imputed using last observation carried forward (LOCF).
Posted
Least Squares Mean
Standard Error
Liters
Day 14, After 2 Weeks of treatment in Stage 1
ID
Title
Description
OG000
Indacaterol 150 µg
In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG001
Indacaterol 300 µg
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Time Frame
Not provided
Description
Safety Population including all participants who received at least one dose of study drug.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Indacaterol 150 µg (Continued Into Stage 2)
In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
35
416
159
416
EG001
Indacaterol 300 µg (Continued Into Stage 2)
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
32
416
159
416
EG002
Tiotropium 18 µg (Continued Into Stage 2)
Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
34
415
156
415
EG003
Placebo (Continued Into Stage 2)
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
35
418
155
418
EG004
Indacaterol 75 µg (Not Continued Into Stage 2)
In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
9
127
39
127
EG005
Indacaterol 600 µg (Not Continued Into Stage 2)
In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
5
122
44
122
EG006
Formoterol 12 µg (Not Continued Into Stage 2)
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
4
122
31
122
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Idiopathic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG0030 affected418 at risk
EG004
Microcytic anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0022 affected415 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA
Systematic Assessment
EG0002 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0012 affected416 at risk
EG0020 affected415 at risk
EG003
Arrhythmia supraventricular
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA
Systematic Assessment
EG0003 affected416 at risk
EG0010 affected416 at risk
EG0023 affected415 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0012 affected416 at risk
EG0020 affected415 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0022 affected415 at risk
EG003
Ischaemic cardiomyopathy
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Endocardial fibroelastosis
Congenital, familial and genetic disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Cataract
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Retinal artery occlusion
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Volvulus
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Chest discomfort
General disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Chills
General disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Sudden death
General disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0012 affected416 at risk
EG0021 affected415 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Herpes zoster oticus
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Localised infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Mycobacterial infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected416 at risk
EG0013 affected416 at risk
EG0024 affected415 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Device failure
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Ear injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0021 affected415 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0022 affected415 at risk
EG003
Skull fractured base
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Blood potassium increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Blood urine present
Investigations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Glasgow coma scale abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Acute leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Anaplastic large cell lymphoma T- and null-cell types
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Benign lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Laryngeal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Renal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Thyroid neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Carotid artery occlusion
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Cerebral haematoma
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Presyncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Sciatica
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0012 affected416 at risk
EG0021 affected415 at risk
EG003
Syncope vasovagal
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Visual midline shift syndrome
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Psychiatric decompensation
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Pelvic peritoneal adhesions
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG00011 affected416 at risk
EG0017 affected416 at risk
EG0027 affected415 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0012 affected416 at risk
EG0020 affected415 at risk
EG003
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Cardioversion
Surgical and medical procedures
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Intermittent claudication
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0011 affected416 at risk
EG0020 affected415 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected416 at risk
EG0010 affected416 at risk
EG0021 affected415 at risk
EG003
Peripheral vascular disorder
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected416 at risk
EG0010 affected416 at risk
EG0020 affected415 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0007 affected416 at risk
EG00117 affected416 at risk
EG00213 affected415 at risk
EG00324 affected418 at risk
EG0042 affected127 at risk
EG0053 affected122 at risk
EG0063 affected122 at risk
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG00033 affected416 at risk
EG00139 affected416 at risk
EG00236 affected415 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG00034 affected416 at risk
EG00127 affected416 at risk
EG00231 affected415 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00013 affected416 at risk
EG00113 affected416 at risk
EG0026 affected415 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG00028 affected416 at risk
EG00118 affected416 at risk
EG00219 affected415 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG00067 affected416 at risk
EG00172 affected416 at risk
EG00275 affected415 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG00030 affected416 at risk
EG00130 affected416 at risk
EG00226 affected415 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
D029424
Pulmonary Disease, Chronic Obstructive
D008173
Lung Diseases, Obstructive
Ancestor Terms
ID
Term
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C510790
indacaterol
D000068759
Formoterol Fumarate
D000069447
Tiotropium Bromide
Ancestor Terms
ID
Term
D004983
Ethanolamines
D000605
Amino Alcohols
D000438
Alcohols
D009930
Organic Chemicals
D000588
Amines
D012602
Scopolamine Derivatives
D014326
Tropanes
D053961
Azabicyclo Compounds
D001372
Aza Compounds
D000470
Alkaloids
D006571
Heterocyclic Compounds
D019086
Bridged Bicyclo Compounds, Heterocyclic
D006572
Heterocyclic Compounds, Bridged-Ring
Browse Leaves
Not provided
Browse Branches
Not provided
6 subjects
FG0055 subjects
FG0061 subjects
1 subjects
FG0051 subjects
FG0062 subjects
1 subjects
FG0051 subjects
FG0061 subjects
3 subjects
FG0052 subjects
FG0062 subjects
1 subjects
FG0050 subjects
FG0061 subjects
1 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0052 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
215
BG00458
BG00560
BG00656
BG0071048
≥65 years
Title
Measurements
BG000202
BG001186
BG002200
BG003203
BG00469
BG00562
BG00666
BG007988
146
BG003163
BG00451
BG00548
BG00652
BG007770
Male
BG000259
BG001263
BG002269
BG003255
BG00476
BG00574
BG00670
BG0071266
376
1.28
± 0.015
Indacaterol 300 µg (Continued Into Stage 2)
In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG002
Tiotropium (Continued Into Stage 2)
Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG003
Placebo (Continued Into Stage 2)
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG003
Placebo
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG004
Indacaterol 75 µg
In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG005
Indacaterol 600 µg
In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG006
Formoterol 12 µg
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG003
Placebo
In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG004
Indacaterol 75 µg
In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG005
Indacaterol 600 µg
In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.
OG006
Formoterol 12 µg
In the morning, Placebo to Indacaterol delivered via SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.
Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study.