CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 257 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Age ≥40 years
  • ✓Diagnosed COPD requiring long-acting dual bronchodilation (LAMA + LABA) per Spiolto® Respimat® SmPC and GOLD guidelines
Key exclusion· 6
  • ✕Any contraindication per Spiolto® Respimat® SmPC
  • ✕Prior LABA/LAMA combination (free or fixed dose) within 6 months
  • ✕Concurrent LABA-ICS therapy (to avoid dual LABA dosing)
  • ✕Pregnancy or lactation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02927795
NCT02927795N/ACompleted
CompareCT.gov

Assessment of Physical Functioning and Handling of Spiolto® Respimat® in Patients With Chronic Obstructive Pulmonary Disease (COPD) Requiring Long-acting Dual Bronchodilation in Routine Clinical Practice

Boehringer Ingelheim·observational·Posted Oct 7, 2016·Updated Sep 30, 2019

In Brief

An observational study for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 257 participants across 79 sites.

Detailed Summary

This is a self-controlled study design enrolling consented COPD patients who will be treated with Spiolto® Respimat® according to the approved SmPC. Patients will be enrolled consecutively and will be followed over an observational period of approx. 6 weeks.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 7, 2016
Enrollment StartApr 26, 2017
Primary CompletionSep 18, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.7 years ago