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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tiotropium-bromide | Drug | Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and final visit (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and final visit (8 weeks) |
| Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Physicians
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim Study Coordinator | BI Pharma Ges mbH Wien | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site | Barnaul | Russia | ||||
| Boehringer Ingelheim Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva® (Tiotropium Bromide) | Tiotropium bromide 18µg inhalation capsules once-daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Inspiratory capacity (IC) post-dose response at end of the observation (Visit 3/week 8) vs. baseline (Visit 1/week 0) at selected sites |
| 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). | 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). | 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). | 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). | final visit (8 weeks) |
| 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 |
| Boehringer Ingelheim Investigational Site | Mezjdurechensk | Russia |
| Boehringer Ingelheim Investigational Site | Moscow | Russia |
| Boehringer Ingelheim Investigational Site | Moscow Region | Russia |
| Boehringer Ingelheim Investigational Site | Nizhny Novgorod | Russia |
| Boehringer Ingelheim Investigational Site | North Ossetia | Russia |
| Boehringer Ingelheim Investigational Site | Novosibirsk | Russia |
| Boehringer Ingelheim Investigational Site | Omsk | Russia |
| Boehringer Ingelheim Investigational Site | Perm | Russia |
| Boehringer Ingelheim Investigational Site | Rostov-on-Don | Russia |
| Boehringer Ingelheim Investigational Site | Ryazan | Russia |
| Boehringer Ingelheim Investigational Site | S-Petersburg | Russia |
| Boehringer Ingelheim Investigational Site | Samara | Russia |
| Boehringer Ingelheim Investigational Site | Saratov | Russia |
| Boehringer Ingelheim Investigational Site | Stavropol | Russia |
| Boehringer Ingelheim Investigational Site | Stavropol Region, North Ossetia | Russia |
| Boehringer Ingelheim Investigational Site | Tomsk | Russia |
| Boehringer Ingelheim Investigational Site | Tyumen | Russia |
| Boehringer Ingelheim Investigational Site | Ufa | Russia |
| Boehringer Ingelheim Investigational Site | Vladivostok | Russia |
| Boehringer Ingelheim Investigational Site | Volgograd | Russia |
| Boehringer Ingelheim Investigational Site | Voroneg | Russia |
| Boehringer Ingelheim Investigational Site | Yaroslavl | Russia |
| Boehringer Ingelheim Investigational Site | Yekaterinburg | Russia |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva® (Tiotropium Bromide) | Tiotropium bromide 18µg inhalation capsules once-daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Full Analysis Set (Intent-to-Treat population) | Posted | Mean | Standard Deviation | liters | baseline and final visit (8 weeks) |
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| Secondary | 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) | Full Analysis Set (Intent-to-Treat population) | Posted | Mean | Standard Deviation | liters | baseline and final visit (8 weeks) |
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| Secondary | 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 | Full Analysis Set (Intent-to-Treat population) and only patients from selected sites | Posted | Mean | Standard Deviation | liters | Visit 1 to Visit 3 (baseline and 8 weeks) |
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| Secondary | 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). | Full Analysis Set (Intent-to-Treat population) | Posted | Number | participants | final visit (8 weeks) |
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| Secondary | 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). | Full Analysis Set (Intent-to-Treat population) | Posted | Number | participants | final visit (8 weeks) |
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| Secondary | 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). | Full Analysis Set (Intent-to-Treat population) | Posted | Number | participants | final visit (8 weeks) |
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| Secondary | 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). | Full Analysis Set (Intent-to-Treat population) | Posted | Number | participants | final visit (8 weeks) |
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8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Spiriva® (Tiotropium Bromide) | Tiotropium bromide 18µg inhalation capsules once-daily | 2 | 407 | 0 | 407 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blastoma of Larynx | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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