COPDNCT00613574

RUSSE / Russian Spiriva® Safety & Efficacy Study

An observational study of COPD, run by Boehringer Ingelheim at 33 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: tiotropium-bromide
Type of treatment: Pill or oral medicine
How many people: 407 participants
Where: 33 sitesRussia
Study dates: Start not givento Oct 2007
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Physicians

Who may be able to join

40 years and older male and female ambulatory outpatients being seen in a participating physicians office for routine care
Patients not previously treated with the Tiotropium
Patients with clinical diagnosis of all stages of Chronic Obstructive Pulmonary Disease according to the current National Guidelines / 2004
Current smokers or ex-smokers with a smoking history of >=10 pack years

Who cannot join

Uncooperative patients as judged by the physician,
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,
Patients with history of known preexisting or concomitant non-obstructive lung disease (e.g., sarcoidosis, tuberculosis, lung cancer),
Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems,
Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva®'s Russian package insert, such as:
Patients with known narrow-angle glaucoma,

Show all 10Show fewer

Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction,
Patient with known moderate to severe renal impairment (creatinine clearance less than 50 ml/min),
Patients with a history of hypersensitivity to atropine or its derivatives, e.g. ipratropium or oxitropium or to any component of this product,
Pregnant or nursing women.

Trial locations and contacts

33 sites in 1 country.

City, postcode or hospital

33 sites in 1 country

Russia33 sites

Boehringer Ingelheim Investigational Site
Barnaul
Boehringer Ingelheim Investigational Site
Chelyabinsk
Boehringer Ingelheim Investigational Site
Irkutsk
Boehringer Ingelheim Investigational Site
Kazan'
Boehringer Ingelheim Investigational Site
Kemerovo
Boehringer Ingelheim Investigational Site
Khabarovsk
Boehringer Ingelheim Investigational Site
Krasnodar
Boehringer Ingelheim Investigational Site
Krasnodar Region
Boehringer Ingelheim Investigational Site
Krasnoyarsk
Boehringer Ingelheim Investigational Site
Kursk
Boehringer Ingelheim Investigational Site
Mezjdurechensk
Boehringer Ingelheim Investigational Site
Moscow
Boehringer Ingelheim Investigational Site
Moscow Region
Boehringer Ingelheim Investigational Site
Nizhny Novgorod
Boehringer Ingelheim Investigational Site
North Ossetia
Boehringer Ingelheim Investigational Site
Novosibirsk
Boehringer Ingelheim Investigational Site
Omsk
Boehringer Ingelheim Investigational Site
Perm
Boehringer Ingelheim Investigational Site
Rostov-on-Don
Boehringer Ingelheim Investigational Site
Ryazan
Boehringer Ingelheim Investigational Site
S-Petersburg
Boehringer Ingelheim Investigational Site
Samara
Boehringer Ingelheim Investigational Site
Saratov
Boehringer Ingelheim Investigational Site
Stavropol
Boehringer Ingelheim Investigational Site
Stavropol Region, North Ossetia
Boehringer Ingelheim Investigational Site
Tomsk
Boehringer Ingelheim Investigational Site
Tyumen
Boehringer Ingelheim Investigational Site
Ufa
Boehringer Ingelheim Investigational Site
Vladivostok
Boehringer Ingelheim Investigational Site
Volgograd
Boehringer Ingelheim Investigational Site
Voroneg
Boehringer Ingelheim Investigational Site
Yaroslavl
Boehringer Ingelheim Investigational Site
Yekaterinburg

Other trials in Russia

About this study

Read the 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.

Conditions: COPD
Being tested: tiotropium-bromide
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tiotropium-bromideDrug
Spiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: baseline and final visit (8 weeks)

Secondary outcomes (6)

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)
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: final visit (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

?Oct 2007

First posted13 Feb 2008 (estimated)
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 407 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00613574
Sponsor's protocol ID: 205.396
Status last verified: Mar 2014
First submitted: 31 Jan 2008
Last updated: 10 Apr 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RUSSE / Russian Spiriva® Safety & Efficacy Study
ClinicalTrials.gov ID: NCT00613574
Acronym / sponsor ID: 205.396
Conditions: COPD
Study type: Observational
Recruitment status: Completed
Enrolment: 407 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study completion: Oct 2007
First posted: 13 Feb 2008 (estimated)
Results: Posted 18 Jan 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Hypothesis:

Primary interest is given to observe change from baseline in post-dose FEV1 after 8 weeks.

Comparison(s):

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Physicians

Key inclusion criteria (4 listed)

40 years and older male and female ambulatory outpatients being seen in a participating physicians office for routine care
Patients not previously treated with the Tiotropium
Patients with clinical diagnosis of all stages of Chronic Obstructive Pulmonary Disease according to the current National Guidelines / 2004
Current smokers or ex-smokers with a smoking history of >=10 pack years

Key exclusion criteria (10 listed)

Uncooperative patients as judged by the physician,
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,
Patients with history of known preexisting or concomitant non-obstructive lung disease (e.g., sarcoidosis, tuberculosis, lung cancer),
Patients currently enrolled in another clinical trial which requires a change in medication for their respiratory problems,
Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva®'s Russian package insert, such as:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tiotropium-bromideSpiriva® inhaled capsule 18 mcg once daily administered via HandiHaler® on the top of usual care	Drug	–

Primary outcome

Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks
Time frame: 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)

6 secondary outcomes

Change From Baseline for Forced Vital Capacity After 8 Weeks
Time frame: baseline and final visit (8 weeks)
Change From Baseline for Inspiratory Capacity (*Only Selected Sites) After 8 Weeks
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)
Time frame: final visit (8 weeks)
Patients Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
Time frame: final visit (8 weeks)
Physicians Global Clinical Assessment of Effect at Final Visit by Severity, FAS
Time frame: final visit (8 weeks)
Physicians Global Clinical Assessment of Tolerability at Final Visit by Severity, FAS
Time frame: final visit (8 weeks)

Results and safety

Results posted to the registry on 18 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spiriva® (Tiotropium Bromide)	407	401

Primary outcome: Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks

Time frame: baseline and final visit (8 weeks). Mean (Standard Deviation). Unit: liters

Measure	Spiriva® (Tiotropium Bromide) n = 401
Value	0.29 (0.43)

Population analysed: Full Analysis Set (Intent-to-Treat population)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiriva® (Tiotropium Bromide)	2 of 407 (0.5%)	0 of 407 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for COPD

Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD
Chronic Obstructive Pulmonary Disease (COPD), Respiratory Muscle Dysfunction
RecruitingPhase 2/3
A Study to Investigate the Efficacy and Safety of Zelicapavir Compared With Placebo in Adults With RSV Who Are at High Risk for Severe Disease
RSV
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim Study Coordinator study chair

BI Pharma Ges mbH Wien

33 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by Boehringer Ingelheim at 33 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Post-dose Forced Expiratory Volume in 1 Second After 8 Weeks (time frame: baseline and final visit (8 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00613574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.