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

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ClinicalTrials.gov Identifier: NCT02055352
Recruitment Status : Completed
First Posted : February 5, 2014
Results First Posted : April 18, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE February 3, 2014
First Posted Date  ICMJE February 5, 2014
Results First Submitted Date  ICMJE January 25, 2017
Results First Posted Date  ICMJE April 18, 2017
Last Update Posted Date April 18, 2017
Actual Study Start Date  ICMJE May 30, 2014
Actual Primary Completion Date January 26, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
Change from baseline in trough Forced Expiratory Volume in 1 second [ 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.
Change History Complete list of historical versions of study NCT02055352 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
  • 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
  • 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.
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
  • 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
  • Percent use of rescue medications [ Time Frame: 24 weeks ]
    Number of times of rescue medication use will be collected via diaries.
  • Adverse events [ Time Frame: 24 weeks ]
    All Adverse events will be documented and reported
  • Change from baseline in trough Forced Expiratory Volume in 1 second at week 24 [ 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.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy/Safety of Combination Budesonide/Indacaterol vs Fluticasone/Salmeterol in Patients With COPD
Official Title  ICMJE 24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD
Brief Summary To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Budesonide
    • Drug: Fluticasone
    • Drug: Indacaterol
    • Drug: Salmeterol
  • Active Comparator: Fluticasone / salmeterol
    Fixed combination of fluticasone and salmeterol
    Interventions:
    • Drug: Fluticasone
    • Drug: Salmeterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2017)
222
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
280
Actual Study Completion Date  ICMJE January 26, 2016
Actual Primary Completion Date January 26, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Brazil,   Chile,   Dominican Republic,   Ecuador,   Honduras,   Mexico,   Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02055352
Other Study ID Numbers  ICMJE CQAB149BAR01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP