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Specific Use-result Surveillance of Spiriva Respimat in Asthmatics
trial testing Spiriva in Asthma in 359 participants. Completed in 28 September 2017.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 359 |
| Start date | 1 June 2015 |
| Primary completion | 1 August 2017 |
| Estimated completion | 28 September 2017 |
| Sites | 1 location across Brazil |
Boehringer Ingelheim — full company profile →
15 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of patients with ADRs are presented. There was no primary outcome for effectiveness as the primary objective of the surveillance is the evaluation of safety.
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 5.59 |
The effectiveness was determined based on the change of asthma control status from baseline at Week 52 which is the secondary endpoint in the surveillance. The asthma control status was rated on a 3-point scale of well controlled, insufficiently controlled and poorly controlled based on asthma symptoms (in the daytime or at night), use of reliever and limitation of activities including exercise (based on "Asthma prevention and management guideline"). Well-controlled=WC, Insufficiently-controlled=IC, Poorly-controlled=PC, Unknown=Unk, Missing=Miss, Baseline=BL, Week 52=W52
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 66.67 |
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 58.12 |
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 35.14 |
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 50.00 |
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 0.00 |
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 0.00 |
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 17.95 |
| Group | Value | 95% CI |
|---|---|---|
| Spiriva® Respimat® | 22.52 |
Time frame: From first drug administration until 30 days after last drug administration.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Spiriva® Respimat® |
|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | — |
| Pneumonia | Infections and infestations | — |
| Cerebral infarction | Nervous system disorders | — |
| Anaphylactic reaction | Immune system disorders | — |
| Cellulitis | Infections and infestations | — |
| Infection | Infections and infestations | — |
| Peritonsillar abscess | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | — |
| Deep vein thrombosis | Vascular disorders | — |
Most-reported serious reactions: Asthma, Pneumonia, Cerebral infarction, Anaphylactic reaction, Cellulitis, Infection, Peritonsillar abscess, Urinary tract infection.
Data from ClinicalTrials.gov NCT02489981 adverse events section.
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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