15 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Suspected Adverse Drug Reactions (ADRs)Primary· From first drug administration until 30 days after last drug administration; up to 337 days
Number of participants with suspected adverse drug reactions (ADRs) is presented.
An Adverse Event (AE) was considered to be ADR if either the physician who reported the AE or the sponsor assessed its causal relationship as related.
Group
Value
95% CI
Spiriva Respimat Group
5
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management GuidelineSecondary· baseline and 12 weeks
The change from baseline in asthma control status at week 12 using Asthma prevention and management guideline is presented.
Well controlled is a better outcome compared to Insufficiently controlled and Poorly controlled outcomes.
Abbreviations used:
Baseline (BL), Week 12 (W12), Well-controlled (WC), Insufficiently controlled (IC), Poorly controlled (PC), Unknown (UNK), Missing (MIS); If a patient was well-controlled at baseline and maintained the state until Week 12, the effectiveness was assessed as "no change". If a patient insufficiently controlled or poorly controlled at baseline becam
BL- WC W12-WC
Group
Value
95% CI
Spiriva Respimat Group
9
BL-WC W12-IC
Group
Value
95% CI
Spiriva Respimat Group
0
BL-WC W12-PC
Group
Value
95% CI
Spiriva Respimat Group
0
BL-WC W12-UNK
Group
Value
95% CI
Spiriva Respimat Group
0
BL-WC W12-MIS
Group
Value
95% CI
Spiriva Respimat Group
0
BL-IC W12-WC
Group
Value
95% CI
Spiriva Respimat Group
68
BL-IC W12-IC
Group
Value
95% CI
Spiriva Respimat Group
39
BL-IC W12-PC
Group
Value
95% CI
Spiriva Respimat Group
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From first drug administration until 30 days after last drug administration; up to 337 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study objective is to investigate the safety and effectiveness of Spiriva Respimat in patients with mild to moderate persistent asthma under real-world use
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT03692676 — Characteristics of Pts Initiating Spiriva Respimat in Asthma
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 27 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03188120.