Trial Outcomes & Findings for Specific Use-result Surveillance of Spiriva Respimat in Asthmatics (NCT NCT02489981)
NCT ID: NCT02489981
Last Updated: 2019-02-11
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
359 participants
Primary outcome timeframe
Week 52
Results posted on
2019-02-11
Participant Flow
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.
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.
Participant milestones
| Measure |
Spiriva® Respimat®
Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
|
|---|---|
|
Overall Study
STARTED
|
340
|
|
Overall Study
COMPLETED
|
213
|
|
Overall Study
NOT COMPLETED
|
127
|
Reasons for withdrawal
| Measure |
Spiriva® Respimat®
Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
|
|---|---|
|
Overall Study
Adverse Event
|
21
|
|
Overall Study
Insufficient effectiveness
|
16
|
|
Overall Study
Improved
|
31
|
|
Overall Study
Lost to Follow-up
|
31
|
|
Overall Study
Other than listed
|
28
|
Baseline Characteristics
SafetySet
Baseline characteristics by cohort
| Measure |
Spiriva® Respimat®
n=340 Participants
Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
|
|---|---|
|
Age, Continuous
|
60.5 Years
STANDARD_DEVIATION 15.0 • n=340 Participants • SafetySet
|
|
Sex: Female, Male
Female
|
183 Participants
n=340 Participants • Safety Set
|
|
Sex: Female, Male
Male
|
157 Participants
n=340 Participants • Safety Set
|
PRIMARY outcome
Timeframe: Week 52Population: 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.
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.
Outcome measures
| Measure |
Spiriva® Respimat®
n=340 Participants
Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
|
|---|---|
|
Percentage of Patients With Suspected Adverse Drug Reactions (ADRs)
|
5.59 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: 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.
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
Outcome measures
| Measure |
Spiriva® Respimat®
n=248 Participants
Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
|
|---|---|
|
Change From Baseline in Asthma Control Status at Week 52
Unk_BL & Unk_52
|
25.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
WC_BL & WC_52
|
66.67 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
IC_BL & WC_52
|
58.12 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
PC_BL & WC_52
|
35.14 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Unk_BL & WC_52
|
50.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Miss_BL & WC_52
|
0.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
WC_BL & IC_52
|
0.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
IC_BL & IC_52
|
17.95 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
PC_BL & IC_52
|
22.52 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Unk_BL & IC_52
|
25.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Miss_BL & IC_52
|
25.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
WC_BL & PC_52
|
0.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
IC_BL & PC_52
|
4.27 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
PC_BL & PC_52
|
17.12 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Unk_BL & PC_52
|
0.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Miss_BL & PC_52
|
0.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
WC_BL & Unk_52
|
0.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
IC_BL & Unk_52
|
2.56 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
PC_BL & Unk_52
|
0.90 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Miss_BL & Unk_52
|
0.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
WC_BL & Miss_52
|
33.33 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
IC_BL & Miss_52
|
17.09 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
PC_BL & Miss_52
|
24.32 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Unk_BL & Miss_52
|
0.00 Percentage of participants
|
|
Change From Baseline in Asthma Control Status at Week 52
Miss_BL & Miss_52
|
75.00 Percentage of participants
|
Adverse Events
Spiriva® Respimat®
Serious events: 10 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Spiriva® Respimat®
n=340 participants at risk
Patients were administered Tiotropium as two puffs 2.5 microgram (μg) (5 μg total dose) via the Respimat inhaler once daily
|
|---|---|
|
Immune system disorders
Anaphylactic reaction
|
0.29%
1/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Infections and infestations
Pneumonia
|
0.59%
2/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Infections and infestations
Cellulitis
|
0.29%
1/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Infections and infestations
Infection
|
0.29%
1/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Infections and infestations
Peritonsillar abscess
|
0.29%
1/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Nervous system disorders
Cerebral infarction
|
0.59%
2/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.88%
3/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.29%
1/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
1/340 • From first drug administration until 30 days after last drug administration.
The safety set (The safety set includes all patients registered in the study and received the treatment) was used for adverse event reporting. A total of 359 patients were registered and Case Report Form (CRFs) were collected from 352 patients. The safety set includes 340 patients, excluding 12 patients who had no visit after registration.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place