Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD (COMBINE)

April 17, 2017 updated by: Novartis Pharmaceuticals

24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD

To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD

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.
222

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, C1125ABE
        • Novartis Investigative Site
      • Ciudad Autonoma de Bs As, Argentina, C1425FVH
        • Novartis Investigative Site
      • Salta, Argentina, 4000
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1056ABJ
        • Novartis Investigative Site
      • Florida, Buenos Aires, Argentina, B1602DQD
        • Novartis Investigative Site
      • La Plata, Buenos Aires, Argentina, 1900
        • Novartis Investigative Site
      • Vicente Lopez, Buenos Aires, Argentina, B1638AAI
        • Novartis Investigative Site
      • Zarate, Buenos Aires, Argentina, 2800
        • Novartis Investigative Site
    • La Pampa
      • Santa Rosa, La Pampa, Argentina
        • Novartis Investigative Site
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 021941-617
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90880-480
        • Novartis Investigative Site
    • SP
      • Sao Bernardo do Campo, SP, Brazil, 09750-420
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 01244-030
        • Novartis Investigative Site
  • Chile
      • Rancagua, Chile, 2841959
        • Novartis Investigative Site
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8431633
        • Novartis Investigative Site
  • Dominican Republic
    • Republica Dominicana
      • Santo Domingo, Republica Dominicana, Dominican Republic
        • Novartis Investigative Site
      • Santo Domingo, Republica Dominicana, Dominican Republic, 10205
        • Novartis Investigative Site
  • Ecuador
    • Guayas
      • Guayaquil, Guayas, Ecuador, 412
        • Novartis Investigative Site
  • Honduras
      • San Pedro Sula, Honduras, 21102
        • Novartis Investigative Site
      • Tegucigalpa, Honduras
        • Novartis Investigative Site
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14050
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 03310
        • Novartis Investigative Site
      • Mexico, Distrito Federal, Mexico, 06760
        • Novartis Investigative Site
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Novartis Investigative Site
  • Panama
    • Panamá
      • Panama City, Panamá, Panama
        • 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:

  • Written informed consent must be obtained before any assessment is performed
  • Outpatients with stable COPD groups C and D according to the 2011 GOLD Guidelines.
  • Current or ex-smokers who have a smoking history of at least 10 pack years
  • Patients with a history of at least one exacerbation.
  • Patients able to read and complete

Exclusion Criteria:

  • Use of other investigational drugs within 30 days
  • Patients with a history of hypersensitivity to any of the study drugs
  • History or current diagnosis of ECG abnormalities
  • Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range
  • Patients who have not achieved an acceptable spirometry result at Visit 1
  • Patients with a body mass index (BMI) of more than 40 kg/m2
  • Patients with lung cancer or a history of lung cancer
  • Patients with a history of malignancy of any organ system
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment
  • Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers)
  • Patients that are uncontrolled or unstable on permitted therapy, who in the opinion of the investigator, have clinically significant renal, cardiovascular, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or haematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment
  • Patients requiring oxygen therapy for chronic hypoxemia
  • Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
  • Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disorder or pulmonary hypertension
  • Patients with a known diagnosis of Alpha-1 Antitrypsin deficiency.
  • Patients with history of lung surgery
  • Patients who are participating in the active phase of a supervised pulmonary rehabilitation program.
  • Patients with a history of 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 Assignment
  • Masking: None (Open Label)

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: Budesonide/indacaterol
Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
Drug: Budesonide
Budesonide 400 mcg twice a day via Breezhaler® device
Drug: Fluticasone
Fluticasone 250 mcg twice daily via Accuhaler® device
Drug: Indacaterol
Indacaterol 150 mcg once daily via Breezhaler® device
Drug: Salmeterol
Salmeterol 50 mcg twice daily via Diskus® device
Active Comparator: Fluticasone / salmeterol
Fixed combination of fluticasone and salmeterol
Drug: Fluticasone
Fluticasone 250 mcg twice daily via Accuhaler® device
Drug: Salmeterol
Salmeterol 50 mcg twice daily via Diskus® device

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
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (Non-inferiority Analysis).
Time Frame: Baseline and week 12
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Baseline and week 12

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
Change in Health Status - mMRC
Time Frame: Baseline, week 12 and week 24
Modified Medical Research Council scale (mMRC) questionnaire will be completed by participants. 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing
Baseline, week 12 and week 24
Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Used Over the 24 Week Treatment
Time Frame: 24 weeks
A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.
24 weeks
Change From Baseline in Trough Forced Expiratory Volume in 1 Second at Week 24 (Analysis of Superiority)
Time Frame: Baseline and week 24
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Baseline and week 24
Change in Health Status - SGRQ-C
Time Frame: Baseline, week 12 and week 24
St George's Respiratory Questionnaire short version questionnaire will be completed by participants. The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life)
Baseline, week 12 and week 24

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 (Actual)

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.
May 30, 2014

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.
January 26, 2016

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.
January 26, 2016

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).
February 3, 2014

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.
February 4, 2014

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.
February 5, 2014

Study Record Updates

Last Update Posted (Actual)

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 18, 2017

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 17, 2017

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, 2017

More Information

Terms related to this study

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.
  • CQAB149BAR01

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.

Clinical Trials on Chronic Obstructive Pulmonary Disease

Clinical Trials on Budesonide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings