Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2396 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Tolerability of Symbicort as an add-on Treatment to Spiriva Compare With Spiriva Alone in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01397890

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED PHASE4

Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.

NCT00496470

Chronic Obstructive Pulmonary Disease, COPD

COMPLETED PHASE4

Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®

NCT01803555

Asthma

COMPLETED PHASE3

Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma

NCT02062463

Asthma

COMPLETED PHASE3

Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis

NCT02546297

COPD Bronchiectasis

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Using US claims data from the HealthCore Integrated Research Environment, COPD patients ≥40 years old initiating BFC or tiotropium between 3/1/2009-2/28/2012 and considered at risk for a future exacerbation were identified and followed for 12 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD Exacerbation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Symbicort

BFC patients new to ICS/LABA and LAMA therapies

No interventions assigned to this group

Spiriva

Tiotropium bromide patients new to ICS/LABA and LAMA therapies

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Continuous health plan enrollment for 12 months before and after index Rx
* At least one prescription fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim.
* COPD diagnosis, and aged 40 years of age at time of first prescription
* At risk population for COPD exacerbations

Exclusion Criteria

* ICS/LABA combination or LAMA therapy during pre-index period
* Patients with prescription claim for budesonide/formoterol and tiotropium bromide on the same day
* Patients diagnosed with cancer
* Patients with long-term OCS medication use during pre-index period

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No