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Trial · NCT04172701

Outcomes49

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence Rate for the First Pneumonia Event
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
patients/1000 person-yearsNUMBER
PRIMARYIncidence Rate of Pneumonia Events
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
events/1000 person-yearsNUMBER
PRIMARYTime to First Pneumonia Event From the Index Date
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
daysMEAN
PRIMARYNumber of Patients With Pneumonia Event
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYIncidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types)Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
patients/1000 person-yearsNUMBER
PRIMARYIncidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events (All Types)Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
events/1000 person-yearsNUMBER
PRIMARYNumber of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation EventsUp to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYTime to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event From the Index DateUp to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
daysMEAN
PRIMARYIncidence Rate of Initiating Triple Combination Therapy
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
patients/1000 person-yearsNUMBER
PRIMARYNumber of Patients Who Initiated a Triple Combination Therapy
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYTime to Initiating Triple Combination Therapy From the Index Date
From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
daysMEDIAN
SECONDARYAll-cause Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN
SECONDARYAll-cause Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN
SECONDARYAll-cause Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN
SECONDARYAll-cause Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) Visits (Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN
SECONDARYAll-cause Healthcare Resource Utilization (HCRU): Number of Intensive Care Unit (ICU) Visits (Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN
SECONDARYChronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN
SECONDARYChronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN
SECONDARYChronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN
SECONDARYChronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) (Visits Per Person Per Month)Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Propensity score matching population: To address the imbalance of potential confounders between LAMA and ICS/LABA groups, treatment groups were matched using propensity scores estimated as by multiple logistic regression analysis based on age, sex, socioeconomics status, Charlson Comorbidity Index, asthma and history of chronic obstructive pulmonary disease (COPD) exacerbation.
visits per person per monthMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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