At the moment, there is hardly any structured safety and efficacy data collection on Tiotropium in Russia. Therefore, the objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation capsules) delivered by HandiHaler®, in a national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8 weeks.
The objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 µg tiotropium inhalation capsules) delivered by HandiHaler®, in national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in the real life setting over the 8 weeks. Study Hypothesis: Primary interest is given to observe change from baseline in post-dose FEV1 after 8 weeks. Comparison(s): The objective of this observational study is to collect and evaluate data on bronchodilator efficacy and safety of Spiriva® (18 mcg tiotropium inhalation capsules) delivered by HandiHaler®, in national sample of Russian patients with varying severities of chronic obstructive pulmonary disease (COPD) in a real life setting over the 8 weeks.
Study Type
OBSERVATIONAL
Enrollment
407
Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care
Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks
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)
Time frame: baseline and final visit (8 weeks)
Change From Baseline for Forced Vital Capacity After 8 Weeks
Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0)
Time frame: baseline and final visit (8 weeks)
Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks
Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites
Time frame: Visit 1 to Visit 3 (baseline and 8 weeks)
Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)
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).
Time frame: final visit (8 weeks)
Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
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).
Time frame: final visit (8 weeks)
Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS
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).
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Boehringer Ingelheim Investigational Site
Barnaul, Russia
Boehringer Ingelheim Investigational Site
Chelyabinsk, Russia
Boehringer Ingelheim Investigational Site
Irkutsk, Russia
Boehringer Ingelheim Investigational Site
Kazan', Russia
Boehringer Ingelheim Investigational Site
Kemerovo, Russia
Boehringer Ingelheim Investigational Site
Khabarovsk, Russia
Boehringer Ingelheim Investigational Site
Krasnodar, Russia
Boehringer Ingelheim Investigational Site
Krasnodar Region, Russia
Boehringer Ingelheim Investigational Site
Krasnoyarsk, Russia
Boehringer Ingelheim Investigational Site
Kursk, Russia
...and 23 more locations
Time frame: final visit (8 weeks)
Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
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).
Time frame: final visit (8 weeks)