Trial Outcomes & Findings for Specific Use-Result of Spiriva Respimat® in Asthmatics (NCT NCT03188120)

Last Updated: 2019-11-27

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

193 participants

Primary outcome timeframe

From first drug administration until 30 days after last drug administration; up to 337 days

Results posted on

2019-11-27

Participant Flow

This was a non-interventional, observational study to collect new real world data (i.e., data under routine medical practice) on safety and effectiveness of Spiriva Respimat treatment in patients.

All participants were screened for eligibility to participate in trial. They attended specialist sites to ensure that they (the participants) met all implemented inclusion/exclusion criteria. Participants were not to be entered to trial if any of the specific entry criteria was violated.

Participant milestones

Participant milestones
Measure	Spiriva Respimat Group Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)
Overall Study STARTED	193
Overall Study COMPLETED	146
Overall Study NOT COMPLETED	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Spiriva Respimat Group Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)
Overall Study Adverse Event	4
Overall Study Insufficient Effectiveness	8
Overall Study Improved	12
Overall Study Lost to Follow-up	7
Overall Study Other than specified	3
Overall Study No visit after the first visit	13

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spiriva Respimat Group n=180 Participants Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)
Age, Continuous	59.4 years STANDARD_DEVIATION 16.8 • n=180 Participants
Sex: Female, Male Female	112 Participants n=180 Participants
Sex: Female, Male Male	68 Participants n=180 Participants

PRIMARY outcome

Timeframe: From first drug administration until 30 days after last drug administration; up to 337 days

Population: Safety set

Outcome measures

Outcome measures
Measure	Spiriva Respimat Group n=180 Participants Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)
Number of Participants With Suspected Adverse Drug Reactions (ADRs)	5 Participants

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Effectiveness set that excluded patients who were not associated with effectiveness data available (pulmonary function test or laboratory values related to asthma control status) as defined at baseline and/or on treatment.

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 became well-controlled at Week 12, or if a patient was poorly controlled at baseline and became insufficiently controlled at Week 12, Spiriva Respimat was assessed as "effective" (or the patient assessed as a responder). If the disease condition did not improve in a patient at Week 12 from baseline, Spiriva Respimat was assessed as "ineffective" (or the patient assessed as a non-responder).

Outcome measures

Outcome measures
Measure	Spiriva Respimat Group n=159 Participants Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this non-interventional, observational study to collect new real world data (i.e., data under routine medical practice)
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL- WC W12-WC	9 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-WC W12-IC	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-IC W12-MIS	6 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-MIS W12-MIS	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-WC W12-PC	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-WC W12-UNK	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-WC W12-MIS	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-IC W12-WC	68 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-IC W12-IC	39 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-IC W12-PC	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-IC W12-UNK	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-PC W12-WC	11 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-PC W12-IC	10 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-PC W12-PC	6 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-PC W12-UNK	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-PC W12-MIS	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-UNK W12-WC	3 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-UNK W12-IC	1 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-UNK W12-PC	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-UNK W12-UNK	4 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-UNK W12-MIS	1 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-MIS W12-WC	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-MIS W12-IC	1 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-MIS W12-PC	0 participants
The Change From Baseline in Asthma Control Status at Week 12 Using Asthma Prevention and Management Guideline BL-MIS W12-UNK	0 participants

Adverse Events

Spiriva Respimat Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spiriva Respimat Group n=180 participants at risk Patients with mild to moderate persistent asthma treated with Spiriva® 1.25 microgram (μg) Respimat® 60 puffs and Spiriva® 2.5 μg Respimat® 60 puffs (hereinafter, Spiriva Respimat). Daily dose was inhalation of the spray of two puffs of Spiriva 2.5 μg Respimat (5 μg of tiotropium) and the spray of two puffs of Spiriva 1.25 μg Respimat (2.5 μg of tiotropium) in this noninterventional, observational study to collect new real world data (i.e., data under routine medical practice)
Infections and infestations Herpes zoster	0.56% 1/180 • From first drug administration until 30 days after last drug administration; up to 337 days 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 193 patients were registered and Case Report Forms (CRFs) were collected from 193 patients. The safety set includes 180 patients, excluding 13 patients who had no visit after the first visit.

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim, Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place