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Trial record 38 of 318 for:    FLUTICASONE AND SALMETEROL

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 )

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Budesonide Drug: Fluticasone Drug: Indacaterol Drug: Salmeterol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD
Actual Study Start Date : May 30, 2014
Actual Primary Completion Date : January 26, 2016
Actual Study Completion Date : January 26, 2016


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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)



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055352


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

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02055352     History of Changes
Other Study ID Numbers: CQAB149BAR01
First Posted: February 5, 2014    Key Record Dates
Results First Posted: April 18, 2017
Last Update Posted: April 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics