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

April 8, 2015 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
581

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B6500EZL
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1125ABE
        • Novartis Investigative Site
      • Buenos Aires, Argentina, C1440BRR
        • Novartis Investigative Site
      • Buenos Aires, Argentina, 1425
        • Novartis Investigative Site
      • Buenos aires, Argentina, C1120AAC
        • Novartis Investigative Site
      • Caba, Argentina, C1119ACN
        • Novartis Investigative Site
      • Cordoba, Argentina, X5016KEH
        • Novartis Investigative Site
      • Mendoza, Argentina, 5500
        • Novartis Investigative Site
      • Mendoza, Argentina, M5500CBA
        • Novartis Investigative Site
      • Salta, Argentina, 4000
        • Novartis Investigative Site
      • Santa Fe, Argentina, S3000FIL
        • Novartis Investigative Site
    • Buenos Aires
      • C A B A, Buenos Aires, Argentina
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1280AEB
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1056ABJ
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1122AAK
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, 1122
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1414AIF
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, 1209
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, 1425
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, 1028
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, B8000XAV
        • Novartis Investigative Site
      • Caba, Buenos Aires, Argentina, C1425DQI
        • Novartis Investigative Site
      • La Plata, Buenos Aires, Argentina, 1900
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Novartis Investigative Site
      • Mar del Plata, Buenos Aires, Argentina, B7600DHK
        • Novartis Investigative Site
      • Quilmes, Buenos Aires, Argentina, B1878FNR
        • Novartis Investigative Site
    • Córdoba
      • Villa María, Córdoba, Argentina, X5900JKA
        • Novartis Investigative Site
    • Entre Ríos
      • Concepción del Uruguay, Entre Ríos, Argentina, 3260
        • Novartis Investigative Site
    • Rosario
      • Santa Fe, Rosario, Argentina, S2000DBS
        • Novartis Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CXH
        • Novartis Investigative Site
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Novartis Investigative Site
      • San Miguel de Tucuman, Tucuman, Argentina, T4000IFL
        • Novartis Investigative Site
  • Colombia
      • Barranquilla, Colombia
        • Novartis Investigative Site
      • Bogotá, Colombia
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Novartis Investigative Site
  • Italy
    • BA
      • Acquaviva delle Fonti, BA, Italy, 70021
        • Novartis Investigative Site
      • Cassano delle Murge, BA, Italy, 70020
        • Novartis Investigative Site
    • BG
      • Treviglio, BG, Italy, 24047
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • CE
      • Caserta, CE, Italy, 81100
        • Novartis Investigative Site
    • FC
      • Forlì, FC, Italy, 47100
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italy, 44100
        • Novartis Investigative Site
    • FG
      • Foggia, FG, Italy, 71100
        • Novartis Investigative Site
    • FR
      • Cassino, FR, Italy, 03043
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italy, 16132
        • Novartis Investigative Site
    • ME
      • Messina, ME, Italy, 98158
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20123
        • Novartis Investigative Site
      • Milano, MI, Italy, 20142
        • Novartis Investigative Site
      • Milano, MI, Italy, 20126
        • Novartis Investigative Site
    • Mi
      • Sesto San Giovanni, Mi, Italy, 20099
        • Novartis Investigative Site
    • PD
      • Cittadella, PD, Italy, 35013
        • Novartis Investigative Site
    • PI
      • Pisa, PI, Italy, 56124
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italy, 33170
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italy, 43100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • SA
      • Salerno, SA, Italy, 84131
        • Novartis Investigative Site
    • VA
      • Cuasso al Monte, VA, Italy, 21050
        • Novartis Investigative Site
      • Tradate, VA, Italy, 21049
        • Novartis Investigative Site
    • VR
      • Negrar, VR, Italy, 37024
        • Novartis Investigative Site
      • Verona, VR, Italy, 37126
        • Novartis Investigative Site
  • Malaysia
      • Pulau Pinang, Malaysia, 10990
        • Novartis Investigative Site
    • Kuala Lumpur
      • Wilayah Persekutuan, Kuala Lumpur, Malaysia, 50590
        • Novartis Investigative Site
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Novartis Investigative Site
  • Mexico
      • Querétaro, Mexico, 76000
        • Novartis Investigative Site
      • San Luis Potosi, Mexico, 78200
        • Novartis Investigative Site
    • Distrito Federal
      • Ciudad De Mexico, Distrito Federal, Mexico, 11950
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 14050
        • Novartis Investigative Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44100
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Novartis Investigative Site
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • Novartis Investigative Site
      • Helmond, Netherlands, 5707 HA
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3045 PM
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28029
        • Novartis Investigative Site
    • Andalucia
      • Loja, Andalucia, Spain, 18300
        • Novartis Investigative Site
      • Sanlúcar de Barrameda, Andalucia, Spain, 11540
        • Novartis Investigative Site
    • Castilla y Leon
      • Valladolid, Castilla y Leon, Spain, 47011
        • Novartis Investigative Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08024
        • Novartis Investigative Site
      • Canet de Mar, Cataluña, Spain, 08360
        • Novartis Investigative Site
      • Corbera de Llobregat, Cataluña, Spain, 08757
        • Novartis Investigative Site
      • Lerida, Cataluña, Spain, 25198
        • Novartis Investigative Site
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novartis Investigative Site
      • Biel, Switzerland, 2500
        • Novartis Investigative Site
      • Gossau, Switzerland, 9200
        • Novartis Investigative Site
      • Muenchenstein, Switzerland, 4241
        • Novartis Investigative Site
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Novartis Investigative Site
      • Chester, United Kingdom, CH2 1UL
        • Novartis Investigative Site
      • East Yorkshire, United Kingdom, HU16 5JQ
        • Novartis Investigative Site
      • Kettering, United Kingdom, NN16 8UZ
        • Novartis Investigative Site
      • Lancaster, United Kingdom, LA1 4RP
        • Novartis Investigative Site
      • Newcastle-upon-Tyne, United Kingdom, NE7 7DN
        • Novartis Investigative Site
      • Surrey, United Kingdom, KT16 0PZ
        • Novartis Investigative Site
    • Perthshire
      • Dundee, Perthshire, United Kingdom, DD1 2BU
        • Novartis Investigative Site
    • Southampton
      • Hants, Southampton, United Kingdom, SO9 5NY
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Indacaterol
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Drug: Indacaterol
Indacaterol is delivered via a SDDPI.
ACTIVE_COMPARATOR: Salmeterol/fluticasone propionate
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.)
Drug: Salmeterol
Salmeterol/fluticasone is delivered via a MDDPI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
Time Frame: 12 weeks
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons
Time Frame: 26 weeks
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.
26 weeks
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
Time Frame: 12 weeks
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.
12 weeks
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
Time Frame: 26 weeks
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 .
26 weeks
FVC Over 26 Weeks of Treatment
Time Frame: 12 and 26 weeks
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.
12 and 26 weeks
Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison
Time Frame: 12 and 26 weeks
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.
12 and 26 weeks
TDI Focal Score at Week 12 and Week 26: Treatment Comparisons
Time Frame: 12 and 26 weeks
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.
12 and 26 weeks
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
Time Frame: 26 weeks
The number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.
26 weeks
Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
Time Frame: 12 and 26 weeks
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.
12 and 26 weeks
Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'
Time Frame: 26 weeks
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'.
26 weeks
St Georges Respiratory Questionnaire for COPD
Time Frame: 12 and 26 weeks
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.
12 and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQAB149B2401
  • 2011-003732-31 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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