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Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.) (INSTEAD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Indacaterol
Salmeterol
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Indacaterol, Salmeterol/fluticasone propionate

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with moderate COPD (Stage II)
  • Able to perform spirometry assessments
  • Current or ex-smokers
  • On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1.

Exclusion Criteria:

  • Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year.
  • Having a history of, or current ECG abnormality
  • Asthma

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indacaterol

Salmeterol/fluticasone propionate

Arm Description

Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)

Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)

Outcomes

Primary Outcome Measures

Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.

Secondary Outcome Measures

Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons
Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11.
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group .
FVC Over 26 Weeks of Treatment
FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.
Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison
The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated.
TDI Focal Score at Week 12 and Week 26: Treatment Comparisons
The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea.
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.
Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use.
Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'
A 'day with no rescue use' is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of 'days with no rescue use' will be derived and analyzed as for the percentage of 'nights with no nighttime awakenings'.
St Georges Respiratory Questionnaire for COPD
A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.

Full Information

First Posted
March 13, 2012
Last Updated
April 8, 2015
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01555138
Brief Title
Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)
Acronym
INSTEAD
Official Title
A Randomized, Double-blind, Parallel-group, 26-week Study Comparing the Efficacy and Safety of Indacaterol (Onbrez® Breezhaler® 150 mcg o.d.) With Salmeterol/Fluticasone Propionate (Seretide® Accuhaler® 50 mcg/500 mcg b.i.d.) in Patients With Moderate Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Indacaterol, Salmeterol/fluticasone propionate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
581 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indacaterol
Arm Type
Experimental
Arm Description
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Arm Title
Salmeterol/fluticasone propionate
Arm Type
Active Comparator
Arm Description
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
Intervention Type
Drug
Intervention Name(s)
Indacaterol
Intervention Description
Indacaterol is delivered via a SDDPI.
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Intervention Description
Salmeterol/fluticasone is delivered via a MDDPI
Primary Outcome Measure Information:
Title
Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
Description
Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons
Description
Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11.
Time Frame
26 weeks
Title
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
Description
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.
Time Frame
12 weeks
Title
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
Description
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group .
Time Frame
26 weeks
Title
FVC Over 26 Weeks of Treatment
Description
FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.
Time Frame
12 and 26 weeks
Title
Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison
Description
The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated.
Time Frame
12 and 26 weeks
Title
TDI Focal Score at Week 12 and Week 26: Treatment Comparisons
Description
The Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea.
Time Frame
12 and 26 weeks
Title
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
Description
The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.
Time Frame
26 weeks
Title
Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
Description
The mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use.
Time Frame
12 and 26 weeks
Title
Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'
Description
A 'day with no rescue use' is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of 'days with no rescue use' will be derived and analyzed as for the percentage of 'nights with no nighttime awakenings'.
Time Frame
26 weeks
Title
St Georges Respiratory Questionnaire for COPD
Description
A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.
Time Frame
12 and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with moderate COPD (Stage II) Able to perform spirometry assessments Current or ex-smokers On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1. Exclusion Criteria: Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year. Having a history of, or current ECG abnormality Asthma Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
C A B A
State/Province
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1028
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1122
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1209
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
B8000XAV
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1122AAK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425DQI
Country
Argentina
Facility Name
Novartis Investigative Site
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600DHK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878FNR
Country
Argentina
Facility Name
Novartis Investigative Site
City
Villa María
State/Province
Córdoba
ZIP/Postal Code
X5900JKA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Concepción del Uruguay
State/Province
Entre Ríos
ZIP/Postal Code
3260
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
State/Province
Rosario
ZIP/Postal Code
S2000DBS
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CXH
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
T4000IFL
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
B6500EZL
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1125ABE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1440BRR
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Novartis Investigative Site
City
Mendoza
ZIP/Postal Code
M5500CBA
Country
Argentina
Facility Name
Novartis Investigative Site
City
Salta
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
S3000FIL
Country
Argentina
Facility Name
Novartis Investigative Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Novartis Investigative Site
City
Barranquilla
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogotá
Country
Colombia
Facility Name
Novartis Investigative Site
City
Acquaviva delle Fonti
State/Province
BA
ZIP/Postal Code
70021
Country
Italy
Facility Name
Novartis Investigative Site
City
Cassano delle Murge
State/Province
BA
ZIP/Postal Code
70020
Country
Italy
Facility Name
Novartis Investigative Site
City
Treviglio
State/Province
BG
ZIP/Postal Code
24047
Country
Italy
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Novartis Investigative Site
City
Caserta
State/Province
CE
ZIP/Postal Code
81100
Country
Italy
Facility Name
Novartis Investigative Site
City
Forlì
State/Province
FC
ZIP/Postal Code
47100
Country
Italy
Facility Name
Novartis Investigative Site
City
Cona
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Novartis Investigative Site
City
Foggia
State/Province
FG
ZIP/Postal Code
71100
Country
Italy
Facility Name
Novartis Investigative Site
City
Cassino
State/Province
FR
ZIP/Postal Code
03043
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Messina
State/Province
ME
ZIP/Postal Code
98158
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20123
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20126
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
Facility Name
Novartis Investigative Site
City
Sesto San Giovanni
State/Province
Mi
ZIP/Postal Code
20099
Country
Italy
Facility Name
Novartis Investigative Site
City
Cittadella
State/Province
PD
ZIP/Postal Code
35013
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Pordenone
State/Province
PN
ZIP/Postal Code
33170
Country
Italy
Facility Name
Novartis Investigative Site
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novartis Investigative Site
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Novartis Investigative Site
City
Salerno
State/Province
SA
ZIP/Postal Code
84131
Country
Italy
Facility Name
Novartis Investigative Site
City
Cuasso al Monte
State/Province
VA
ZIP/Postal Code
21050
Country
Italy
Facility Name
Novartis Investigative Site
City
Tradate
State/Province
VA
ZIP/Postal Code
21049
Country
Italy
Facility Name
Novartis Investigative Site
City
Negrar
State/Province
VR
ZIP/Postal Code
37024
Country
Italy
Facility Name
Novartis Investigative Site
City
Verona
State/Province
VR
ZIP/Postal Code
37126
Country
Italy
Facility Name
Novartis Investigative Site
City
Wilayah Persekutuan
State/Province
Kuala Lumpur
ZIP/Postal Code
50590
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Ciudad De Mexico
State/Province
Distrito Federal
ZIP/Postal Code
11950
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Novartis Investigative Site
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64718
Country
Mexico
Facility Name
Novartis Investigative Site
City
Querétaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
Novartis Investigative Site
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Novartis Investigative Site
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Loja
State/Province
Andalucia
ZIP/Postal Code
18300
Country
Spain
Facility Name
Novartis Investigative Site
City
Sanlúcar de Barrameda
State/Province
Andalucia
ZIP/Postal Code
11540
Country
Spain
Facility Name
Novartis Investigative Site
City
Valladolid
State/Province
Castilla y Leon
ZIP/Postal Code
47011
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08024
Country
Spain
Facility Name
Novartis Investigative Site
City
Canet de Mar
State/Province
Cataluña
ZIP/Postal Code
08360
Country
Spain
Facility Name
Novartis Investigative Site
City
Corbera de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08757
Country
Spain
Facility Name
Novartis Investigative Site
City
Lerida
State/Province
Cataluña
ZIP/Postal Code
25198
Country
Spain
Facility Name
Novartis Investigative Site
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Novartis Investigative Site
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Biel
ZIP/Postal Code
2500
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Gossau
ZIP/Postal Code
9200
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Muenchenstein
ZIP/Postal Code
4241
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Dundee
State/Province
Perthshire
ZIP/Postal Code
DD1 2BU
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Hants
State/Province
Southampton
ZIP/Postal Code
SO9 5NY
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
East Yorkshire
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Kettering
ZIP/Postal Code
NN16 8UZ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)

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