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A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01794780
Recruitment Status : Completed
First Posted : February 20, 2013
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This multi-center study is designed to describe natural history of disease, treatment and health care products in physician-diagnosed COPD patients who require adding daily maintenance therapy in real world.

The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set.

A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.


Condition or disease Intervention/treatment Phase
COPD Drug: LABA based treatment: indacaterol Drug: LAMA based treatment: tiotropium Drug: LABA/ICS based treatment: salmeterol/fluticasone Drug: LABA/ICS based treatment: budesonide/formoterol Drug: theophylline based treatment Drug: Other treatment Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2229 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Actual Study Start Date : February 5, 2013
Actual Primary Completion Date : May 25, 2015
Actual Study Completion Date : May 25, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Indacaterol
LABA: Indacaterol, once a day, 150μg each time
Drug: LABA based treatment: indacaterol
LABA based treatment: indacaterol

Experimental: Tiotropium Bromide
LAMA: Tiotropium Bromide, once a day, 18 μg
Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium

Experimental: Salmeterol/Fluticasone
LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
Drug: LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: salmeterol/fluticasone

Experimental: Budesonide/ formoterol
Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
Drug: LABA/ICS based treatment: budesonide/formoterol
LABA/ICS based treatment: budesonide/formoterol

Experimental: Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
Drug: LABA based treatment: indacaterol
LABA based treatment: indacaterol

Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium

Experimental: LABA/ICS (Or budesonide/ formoterol)+ Tiotropium
Salmeterol / fluticasone Or budesonide / formoterol
Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium

Drug: LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: salmeterol/fluticasone

Drug: LABA/ICS based treatment: budesonide/formoterol
LABA/ICS based treatment: budesonide/formoterol

Experimental: Oral theophylline Drug: theophylline based treatment
theophylline based treatment

Experimental: Other treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Drug: Other treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"




Primary Outcome Measures :
  1. Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline,3 months ]
    Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the Long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.


Secondary Outcome Measures :
  1. Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline,12 months ]
    Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.

  2. COPD Exacerbation [ Time Frame: Baseline,12 months ]
    Number of COPD exacerbations evaluated over 12 months. COPD exacerbation is defined as a new onset or worsening of at least 1 respiratory major symptoms (e.g. dyspnea, cough, sputum volume or sputum purulence) for at least 3 consecutive days, which results in recorded treatment change (antibiotics/steroids/oxygen therapy) OR recorded COPD related hospitalization/Emergency visit. COPD exacerbation is not considered as adverse event, and should only be recorded in COPD e-CRF.

  3. Change in Health Status Questionnaire MMRC [ Time Frame: Baseline,3,6,9,12 months ]
    The mMRC scale is scored from 0 (less severe) to 4 (severe). 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. The modified Medical Research Council (mMRC) Dyspnea Scale , is a five-item instrument (part of the Borg scale) to assess a patient's degree of breathlessness in relation to physical activity. Participants will be required to read a brief description of an activity and then select a statement that best describes their experience with dyspnea at Visit 101. The mMRC was assessed by the investigators at the scheduled visits.

  4. Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score [ Time Frame: Baseline,3,6,9,12 months ]
    The COPD assessment test (CAT) is a short instrument scale used to quantify the symptom burden of COPD and will be used to assess the health status of patients in this study. It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.

  5. Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score [ Time Frame: Baseline,3,6,9,12 months ]
    Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. BDI/TDI was used to assess dyspnea from several aspects, caused by daily activities. These were evaluated by the investigators in the study at the scheduled study visits. The indices were to be evaluated by the same investigator.as far as possible.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide informed consent
  • Physician-diagnosis of COPD
  • COPD patients requiring long-acting bronchodilator treatment
  • Patients with spirometry available at baseline

Exclusion Criteria:

  • Patients who have a diagnosis of asthma.
  • Patients who had been hospitalized for a COPD exacerbation in the 4 weeks prior to Visit 1.
  • Current clinical diagnosis of other chronic respiratory illnesses
  • Concurrent participation in a clinical trial or use of an investigational drug.
  • Active malignancy or history of malignancy of any organ system
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential with no contraception 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): NCT01794780


Locations
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China
Novartis Investigative Site
Beijing, China, 100730
Novartis Investigative Site
Zhengzhou, China
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01794780    
Other Study ID Numbers: CQAB149BCN01
First Posted: February 20, 2013    Key Record Dates
Results First Posted: September 26, 2019
Last Update Posted: September 26, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
COPD
Chronic obstructive pulmonary disease (COPD),
Chronic obstructive lung disease (COLD),
Chronic obstructive airway disease (COAD),
Cronchitis,
Emphysema
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Fluticasone
Budesonide
Theophylline
Formoterol Fumarate
Tiotropium Bromide
Salmeterol Xinafoate
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
Parasympatholytics
Cholinergic Antagonists