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Comparison · NCT04172701-443afb7d

LAMA vs ICS/LABA: Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. LAMA vs ICS/LABA: Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events. Trial comparisons, record NCT04172701-443afb7d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04172701-443afb7d

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.4790.4590.499wilson
Risk in group 20.5260.5060.546wilson
Risk difference, group 1 minus group 2-0.0471-0.075-0.019newcombe hybrid score
Risk ratio, group 1 over group 20.9110.8610.963log
Odds ratio, group 1 over group 20.8280.740.927log
Number needed to treat, for one fewer participant with the outcome on LAMA than on ICS/LABA21.313.352.6from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1LAMAChronic obstructive pulmonary disease (COPD) patients who were prescribed long-acting muscarinic antagonists (LAMA) monotherapy between 01 January 2005 and 30 April 2015.1,1702,444OG000
Group 2ICS/LABA
Chronic obstructive pulmonary disease (COPD) patients who were prescribed a fixed-dose combination (FDC) of inhaled corticosteroid (ICS)/long-acting beta agonists (LABA) between 01 January 2005 and 30 April 2015.
1,2852,444OG001

Outcome

Type
PRIMARY
Title
Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events
Description
Number of patients with Chronic Obstructive Pulmonary Disease (COPD) exacerbation (moderate or severe) events is reported.~Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary \~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription.
Time frame
Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015.
Population
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.

Source ClinicalTrials.gov

Trial

Title
A Study in South Korea Using Medical Records to Look at Different Treatments for Chronic Obstructive Airway Disease (COPD)
NCT number
NCT04172701
Phases
Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
Long-acting Muscarinic Antagonists (LAMA), Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)
Lead sponsor
Boehringer Ingelheim
Results first posted
2022-04-07

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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