Clinical trial NCT00613574: RUSSE / Russian Spiriva® Safety & Efficacy Study
Official title: RUSSE / Russian Spiriva® Safety & Efficacy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 407
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Physicians

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks
timeFrame: baseline and final visit (8 weeks)
Secondary outcomes:
measure: Change From Baseline for Forced Vital Capacity After 8 Weeks
timeFrame: baseline and final visit (8 weeks)
measure: Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks
timeFrame: Visit 1 to Visit 3 (baseline and 8 weeks)
measure: Patients Global Clinical Assessment of Efficacy at Final Visit by Severity, Full Analysis Set (FAS)
timeFrame: final visit (8 weeks)
measure: Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
timeFrame: final visit (8 weeks)
measure: Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS
timeFrame: final visit (8 weeks)
measure: Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
timeFrame: final visit (8 weeks)
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Irkutsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Kazan
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Kemerovo
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Khabarovsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Krasnodar region
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Krasnodar
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Kursk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Mezjdurechensk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow Region
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: N. Novgorod
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: North Ossetia
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Omsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Perm
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Rostov-on-Don
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Ryazan
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: S-Petersburg
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Samara
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Saratov
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Stavropol region, North Ossetia
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Stavropol
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Tomsk
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Tyumen
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Ufa
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Vladivostok
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Volgograd
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Voroneg
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Boehringer Ingelheim Investigational Site
Study officials:
affiliation: BI Pharma Ges mbH Wien
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References: