Asthma
Conditions
Brief summary
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.
Interventions
DRUGSpiriva
60 puffs
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with severe persistent bronchial asthma * Patient aged \>= 15 years * Patients who are naive to Spiriva Respimat and receive Spiriva Respimat for the first time for treatment of bronchial asthma on top of at least ICS (Inhaled corticosteroids) treatment.
Exclusion criteria
* Patients who have a contraindication to Spiriva Respimat defined in the package insert for Spiriva Respimat * Patients who have been enrolled this study before.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) | Week 52 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Asthma Control Status at Week 52 | Baseline and Week 52 | 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 |
Countries
Brazil
Participant flow
Recruitment details
The objective of this Post Marketing Surveillance (PMS) was to investigate the safety and effectiveness of Spiriva Respimat in patients with severe persistent asthma under real-world use. This is a regulatory required PMS to investigate the safety and effectiveness of Spiriva® 2.5 μg Respimat® 60 puffs in patients.
Pre-assignment details
All patients were screened for eligibility to participate in the trial. Patients attended specialist sites to ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria were not met.
Participants by arm
| Arm | Count |
|---|---|
| Spiriva® Respimat® Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily | 340 |
| Total | 340 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 21 |
| Overall Study | Improved | 31 |
| Overall Study | Insufficient effectiveness | 16 |
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Other than listed | 28 |
Baseline characteristics
| Characteristic | Spiriva® Respimat® | — |
|---|---|---|
| Age, Continuous | 60.5 Years STANDARD_DEVIATION 15 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 183 Participants | — |
| Sex: Female, Male Male | 157 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 340 |
| other Total, other adverse events | 0 / 340 |
| serious Total, serious adverse events | 10 / 340 |
Outcome results
Primary
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
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.
Time frame: Week 52
Population: Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiriva Respimat except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spiriva® Respimat® | Percentage of Patients With Suspected Adverse Drug Reactions (ADRs) | 5.59 Percentage of participants |
Secondary
Change From Baseline in Asthma Control Status at Week 52
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
Time frame: Baseline and Week 52
Population: Efficacy set: This patient set is a subset of the safety set that includes all patients in the safety set who have baseline and at least one available on-treatment asthma control status, Peak Expiratory Flow Rate (PEFR), Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) or Asthma Control Questionnaire (ACQ) 6 score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | WC_BL & WC_52 | 66.67 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | IC_BL & WC_52 | 58.12 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | PC_BL & WC_52 | 35.14 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Unk_BL & WC_52 | 50.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Miss_BL & WC_52 | 0.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | WC_BL & IC_52 | 0.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | IC_BL & IC_52 | 17.95 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | PC_BL & IC_52 | 22.52 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Unk_BL & IC_52 | 25.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Miss_BL & IC_52 | 25.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | WC_BL & PC_52 | 0.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | IC_BL & PC_52 | 4.27 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | PC_BL & PC_52 | 17.12 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Unk_BL & PC_52 | 0.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Miss_BL & PC_52 | 0.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | WC_BL & Unk_52 | 0.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | IC_BL & Unk_52 | 2.56 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | PC_BL & Unk_52 | 0.90 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Unk_BL & Unk_52 | 25.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Miss_BL & Unk_52 | 0.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | WC_BL & Miss_52 | 33.33 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | IC_BL & Miss_52 | 17.09 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | PC_BL & Miss_52 | 24.32 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Unk_BL & Miss_52 | 0.00 Percentage of participants |
| Spiriva® Respimat® | Change From Baseline in Asthma Control Status at Week 52 | Miss_BL & Miss_52 | 75.00 Percentage of participants |