COPD
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 40 years and older male and female ambulatory outpatients being seen in a participating physicians office for routine care 2. Patients not previously treated with the Tiotropium 3. Patients with clinical diagnosis of all stages of Chronic Obstructive Pulmonary Disease according to the current National Guidelines / 2004 4. Current smokers or ex-smokers with a smoking history of \>=10 pack years
Exclusion criteria
1. Uncooperative patients as judged by the physician, 2. Patients that have any condition which, according to the participating physicians opinion, might decrease the chance of obtaining satisfactory data to achieve the objectives of the observation, 3. Patients with history of known preexisting or concomitant non-obstructive lung disease (e.g., sarcoidosis, tuberculosis, lung cancer), 4. Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems, 5. Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva®'s Russian package insert, such as: 6. Patients with known narrow-angle glaucoma, 7. Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction, 8. Patient with known moderate to severe renal impairment (creatinine clearance less than 50 ml/min), 9. Patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium or to any component of this product, 10. Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks | baseline and final visit (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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks | Visit 1 to Visit 3 (baseline and 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 |
| Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) | final visit (8 weeks) | 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). |
| Change From Baseline for Forced Vital Capacity After 8 Weeks | baseline and final visit (8 weeks) | Forced vital capacity (FVC) post-dose response at end of the observation (Visit 3/week 8 ) vs. baseline (Visit 1/week 0) |
| Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS | final visit (8 weeks) | 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). |
| Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | final visit (8 weeks) | 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). |
| Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | final visit (8 weeks) | 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). |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spiriva® (Tiotropium Bromide) Tiotropium bromide 18µg inhalation capsules once-daily | 407 |
| Total | 407 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 1 |
Baseline characteristics
| Characteristic | Spiriva® (Tiotropium Bromide) |
|---|---|
| Age, Continuous | 60.2 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 339 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 407 |
| serious Total, serious adverse events | 2 / 407 |
Outcome results
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)
Time frame: baseline and final visit (8 weeks)
Population: Full Analysis Set (Intent-to-Treat population)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva® (Tiotropium Bromide) | Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks | 0.29 liters | Standard Deviation 0.43 |
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)
Time frame: baseline and final visit (8 weeks)
Population: Full Analysis Set (Intent-to-Treat population)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva® (Tiotropium Bromide) | Change From Baseline for Forced Vital Capacity After 8 Weeks | 0.31 liters | Standard Deviation 0.54 |
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
Time frame: Visit 1 to Visit 3 (baseline and 8 weeks)
Population: Full Analysis Set (Intent-to-Treat population) and only patients from selected sites
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spiriva® (Tiotropium Bromide) | Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks | 0.18 liters | Standard Deviation 0.56 |
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).
Time frame: final visit (8 weeks)
Population: Full Analysis Set (Intent-to-Treat population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® (Tiotropium Bromide) | Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) | Excellent | 141 participants |
| Spiriva® (Tiotropium Bromide) | Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) | Good | 198 participants |
| Spiriva® (Tiotropium Bromide) | Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) | Satisfactory | 60 participants |
| Spiriva® (Tiotropium Bromide) | Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS) | Poor | 2 participants |
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).
Time frame: final visit (8 weeks)
Population: Full Analysis Set (Intent-to-Treat population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® (Tiotropium Bromide) | Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Excellent | 246 participants |
| Spiriva® (Tiotropium Bromide) | Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Good | 139 participants |
| Spiriva® (Tiotropium Bromide) | Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Satisfactory | 16 participants |
| Spiriva® (Tiotropium Bromide) | Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Poor | 0 participants |
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).
Time frame: final visit (8 weeks)
Population: Full Analysis Set (Intent-to-Treat population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® (Tiotropium Bromide) | Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS | Satisfactory | 45 participants |
| Spiriva® (Tiotropium Bromide) | Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS | Poor | 2 participants |
| Spiriva® (Tiotropium Bromide) | Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS | Excellent | 159 participants |
| Spiriva® (Tiotropium Bromide) | Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS | Good | 195 participants |
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).
Time frame: final visit (8 weeks)
Population: Full Analysis Set (Intent-to-Treat population)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spiriva® (Tiotropium Bromide) | Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Excellent | 246 participants |
| Spiriva® (Tiotropium Bromide) | Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Good | 144 participants |
| Spiriva® (Tiotropium Bromide) | Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Satisfactory | 11 participants |
| Spiriva® (Tiotropium Bromide) | Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS | Poor | 0 participants |