RUSSE / Russian Spiriva® Safety & Efficacy Study

COPD Clinical Trial

Official title:

RUSSE / Russian Spiriva® Safety & Efficacy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00613574
• Other study ID #: 205.396
• Status: Completed
• Phase: Phase 4
• First received: January 31, 2008
• Last updated: March 12, 2014
• Est. completion date: October 2007

Study information

• Verified date: March 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• tiotropium-bromide
Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care

Locations

Country	Name	City	State
Russian Federation	Boehringer Ingelheim Investigational Site	Barnaul
Russian Federation	Boehringer Ingelheim Investigational Site	Chelyabinsk
Russian Federation	Boehringer Ingelheim Investigational Site	Ekaterinburg
Russian Federation	Boehringer Ingelheim Investigational Site	Irkutsk
Russian Federation	Boehringer Ingelheim Investigational Site	Kazan
Russian Federation	Boehringer Ingelheim Investigational Site	Kemerovo
Russian Federation	Boehringer Ingelheim Investigational Site	Khabarovsk
Russian Federation	Boehringer Ingelheim Investigational Site	Krasnodar
Russian Federation	Boehringer Ingelheim Investigational Site	Krasnodar region
Russian Federation	Boehringer Ingelheim Investigational Site	Krasnoyarsk
Russian Federation	Boehringer Ingelheim Investigational Site	Kursk
Russian Federation	Boehringer Ingelheim Investigational Site	Mezjdurechensk
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow
Russian Federation	Boehringer Ingelheim Investigational Site	Moscow Region
Russian Federation	Boehringer Ingelheim Investigational Site	N. Novgorod
Russian Federation	Boehringer Ingelheim Investigational Site	North Ossetia
Russian Federation	Boehringer Ingelheim Investigational Site	Novosibirsk
Russian Federation	Boehringer Ingelheim Investigational Site	Omsk
Russian Federation	Boehringer Ingelheim Investigational Site	Perm
Russian Federation	Boehringer Ingelheim Investigational Site	Rostov-on-Don
Russian Federation	Boehringer Ingelheim Investigational Site	Ryazan
Russian Federation	Boehringer Ingelheim Investigational Site	S-Petersburg
Russian Federation	Boehringer Ingelheim Investigational Site	Samara
Russian Federation	Boehringer Ingelheim Investigational Site	Saratov
Russian Federation	Boehringer Ingelheim Investigational Site	Stavropol
Russian Federation	Boehringer Ingelheim Investigational Site	Stavropol region, North Ossetia
Russian Federation	Boehringer Ingelheim Investigational Site	Tomsk
Russian Federation	Boehringer Ingelheim Investigational Site	Tyumen
Russian Federation	Boehringer Ingelheim Investigational Site	Ufa
Russian Federation	Boehringer Ingelheim Investigational Site	Vladivostok
Russian Federation	Boehringer Ingelheim Investigational Site	Volgograd
Russian Federation	Boehringer Ingelheim Investigational Site	Voroneg
Russian Federation	Boehringer Ingelheim Investigational Site	Yaroslavl

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	baseline and final visit (8 weeks)	No
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)	baseline and final visit (8 weeks)	No
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	Visit 1 to Visit 3 (baseline and 8 weeks)	No
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).	final visit (8 weeks)	No
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).	final visit (8 weeks)	No
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).	final visit (8 weeks)	No
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).	final visit (8 weeks)	No