N/A
Completed N=116,133
Characteristics of Pts Initiating Spiriva Respimat in Asthma
Source: ClinicalTrials.gov NCT03692676 ↗Enrolled (actual)
116,133
Serious AEs
—
Results posted
Dec 2020
Primary outcomePrimary: Number of Participants With Cardiac Arrhythmias — 11; 17; 102; 16 Participants
Summary
This study is a cross-sectional, non-interventional study based on existing data (NISed).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Cardiac Arrhythmias |
11; 17; 102; 16 | — |
| SECONDARY Number of Participants With Cardiac Failure |
NA; 9; 49; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Aged 18 years and above at the index date
- At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Database (CPRD)
- Had a diagnosis of asthma before the index date
- Being treated with Inhaled corticosteroids/Long-acting beta agonists (ICS LABA FDC) before the index date (at least one prescription within 3 months before the index date)
- Patients who were new users of Spiriva Respimat, or LTRA, or patients who were prescribed a higher dose of ICS/LABA FDC, or patients who switched to a new ICS/LABA FDC from the previous ICS/LABA FDC
Exclusion Criteria
- Patients who were prescribed other Long-acting muscarinic antagonists (LAMA) any time before or on the index date
- In the primary analysis, patients who were diagnosed with COPD before or on the index date will be excluded from the study. In a sensitivity analysis, patients who had both asthma and COPD diagnoses will be included in the study
Data sourced from ClinicalTrials.gov (NCT03692676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.