Trial Outcomes & Findings for RUSSE / Russian Spiriva® Safety & Efficacy Study (NCT NCT00613574)

Results Overview

Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0)

Recruitment status

COMPLETED

Target enrollment

407 participants

Primary outcome timeframe

baseline and final visit (8 weeks)

Results posted on

2014-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Spiriva® (Tiotropium Bromide) Tiotropium bromide 18µg inhalation capsules once-daily
Overall Study STARTED	407
Overall Study COMPLETED	401
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Spiriva® (Tiotropium Bromide) Tiotropium bromide 18µg inhalation capsules once-daily
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	2
Overall Study Other	1

Baseline Characteristics

RUSSE / Russian Spiriva® Safety & Efficacy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spiriva® (Tiotropium Bromide) n=407 Participants Tiotropium bromide 18µg inhalation capsules once-daily
Age, Continuous	60.2 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	339 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and final visit (8 weeks)

Population: Full Analysis Set (Intent-to-Treat population)

Forced expiratory volume in 1 second (FEV1) post-dose response at the end of the observation (Visit 3/week 8) versus (vs.) baseline (Visit 1/week 0)

Outcome measures

Outcome measures
Measure	Spiriva® (Tiotropium Bromide) n=401 Participants Tiotropium bromide 18µg inhalation capsules once-daily
Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks	0.29 liters Standard Deviation 0.43

SECONDARY outcome

Timeframe: baseline and final visit (8 weeks)

Population: Full Analysis Set (Intent-to-Treat population)

Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0)

Outcome measures

Outcome measures
Measure	Spiriva® (Tiotropium Bromide) n=401 Participants Tiotropium bromide 18µg inhalation capsules once-daily
Change From Baseline for Forced Vital Capacity After 8 Weeks	0.31 liters Standard Deviation 0.54

SECONDARY outcome

Timeframe: Visit 1 to Visit 3 (baseline and 8 weeks)

Population: Full Analysis Set (Intent-to-Treat population) and only patients from selected sites

Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites

Outcome measures

Outcome measures
Measure	Spiriva® (Tiotropium Bromide) n=245 Participants Tiotropium bromide 18µg inhalation capsules once-daily
Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks	0.18 liters Standard Deviation 0.56

SECONDARY outcome

Timeframe: final visit (8 weeks)

Population: Full Analysis Set (Intent-to-Treat population)

Patient Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy\&tolerability, 4=poor) at end of the observation (Visit 3/week 8).

Outcome measures

Outcome measures
Measure	Spiriva® (Tiotropium Bromide) n=401 Participants Tiotropium bromide 18µg inhalation capsules once-daily
Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) Excellent	141 participants
Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) Good	198 participants
Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) Satisfactory	60 participants
Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) Poor	2 participants

SECONDARY outcome

Timeframe: final visit (8 weeks)

Population: Full Analysis Set (Intent-to-Treat population)

Patient Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy\&tolerability, 4=poor) at end of the observation (Visit 3/week 8).

Outcome measures

Outcome measures
Measure	Spiriva® (Tiotropium Bromide) n=401 Participants Tiotropium bromide 18µg inhalation capsules once-daily
Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS Excellent	246 participants
Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS Good	139 participants
Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS Satisfactory	16 participants
Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS Poor	0 participants

SECONDARY outcome

Timeframe: final visit (8 weeks)

Population: Full Analysis Set (Intent-to-Treat population)

Physician Global Assessment of Spiriva® efficacy with a 4-point scale (1=excellent efficacy\&tolerability, 4=poor) at end of the observation (Visit 3/week 8).

Outcome measures

Outcome measures
Measure	Spiriva® (Tiotropium Bromide) n=401 Participants Tiotropium bromide 18µg inhalation capsules once-daily
Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS Excellent	159 participants
Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS Good	195 participants
Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS Satisfactory	45 participants
Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS Poor	2 participants

SECONDARY outcome

Timeframe: final visit (8 weeks)

Population: Full Analysis Set (Intent-to-Treat population)

Physician Global Assessment of Spiriva® tolerability with a 4-point scale (1=excellent efficacy\&tolerability, 4=poor) at end of the observation (Visit 3/week 8).

Outcome measures

Outcome measures
Measure	Spiriva® (Tiotropium Bromide) n=401 Participants Tiotropium bromide 18µg inhalation capsules once-daily
Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS Excellent	246 participants
Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS Good	144 participants
Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS Satisfactory	11 participants
Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS Poor	0 participants

Adverse Events

Spiriva® (Tiotropium Bromide)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Spiriva® (Tiotropium Bromide) n=407 participants at risk Tiotropium bromide 18µg inhalation capsules once-daily
Respiratory, thoracic and mediastinal disorders Blastoma of Larynx	0.25% 1/407 • 8 weeks
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.25% 1/407 • 8 weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER