Pulmonary Disease, Chronic ObstructiveNCT00638183

Special Survey Long-term Treatment With Tiotropium on COPD

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 89 sites in Japan.

Completed

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

Trial summary

Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
How many people: 385 participants
Where: 89 sitesJapan
Study dates: Apr 2005to Jan 2009
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: COHORT

Who may be able to join

Patients of Chronic Obstructive Pulmonary Disease
Patients were expected to use the product for long period of time

Who cannot join

Patients with glaucoma
Patients with micturition disorder due to prostatic hyperplasia etc.
Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product

Trial locations and contacts

89 sites in 1 country.

City, postcode or hospital

89 sites in 1 country

Japan89 sites

Boehringer Ingelheim Investigational Site
Asahikawa
Boehringer Ingelheim Investigational Site
Chikushino-shi
Boehringer Ingelheim Investigational Site
Daitō
Boehringer Ingelheim Investigational Site
Ebina
Boehringer Ingelheim Investigational Site
Echizen
Boehringer Ingelheim Investigational Site
Fukui
Boehringer Ingelheim Investigational Site
Fukushima
Boehringer Ingelheim Investigational Site
Funabashi
Boehringer Ingelheim Investigational Site
Gosen
Boehringer Ingelheim Investigational Site
Habikino
Boehringer Ingelheim Investigational Site
Hakodate
Boehringer Ingelheim Investigational Site
Hayashimacho
Boehringer Ingelheim Investigational Site
Higashiosakaka
Boehringer Ingelheim Investigational Site
Himeji
Boehringer Ingelheim Investigational Site
Hirosaki
Boehringer Ingelheim Investigational Site
Hiroshima
Boehringer Ingelheim Investigational Site
Hitachi
Boehringer Ingelheim Investigational Site
Iizuka
Boehringer Ingelheim Investigational Site
Ikoma
Boehringer Ingelheim Investigational Site
Ishinomaki
Boehringer Ingelheim Investigational Site
Itanocho
Boehringer Ingelheim Investigational Site
Kasukabe
Boehringer Ingelheim Investigational Site
Katsuragichō
Boehringer Ingelheim Investigational Site
Kawasaki
Boehringer Ingelheim Investigational Site
Kishiwada
Boehringer Ingelheim Investigational Site
Kitakyushu
Boehringer Ingelheim Investigational Site
Kobayashi
Boehringer Ingelheim Investigational Site
Koga
Boehringer Ingelheim Investigational Site
Komaki
Boehringer Ingelheim Investigational Site
Komatsu
Boehringer Ingelheim Investigational Site
Kōshū
Boehringer Ingelheim Investigational Site
Kumamoto
Boehringer Ingelheim Investigational Site
Kunimichō
Boehringer Ingelheim Investigational Site
Kyōtango
Boehringer Ingelheim Investigational Site
Kyoto
Boehringer Ingelheim Investigational Site
Matsudo
Boehringer Ingelheim Investigational Site
Matsue
Boehringer Ingelheim Investigational Site
Matsumoto
Boehringer Ingelheim Investigational Site
Mihamacho
Boehringer Ingelheim Investigational Site
Minamiuonuma
Boehringer Ingelheim Investigational Site
Mishima
Boehringer Ingelheim Investigational Site
Mizumakimachi
Boehringer Ingelheim Investigational Site
Morioka
Boehringer Ingelheim Investigational Site
Nagaoka
Boehringer Ingelheim Investigational Site
Nagasaki
Boehringer Ingelheim Investigational Site
Nagoya
Boehringer Ingelheim Investigational Site
Nichinan
Boehringer Ingelheim Investigational Site
Niihama
Boehringer Ingelheim Investigational Site
Nōgata
Boehringer Ingelheim Investigational Site
Numata
Boehringer Ingelheim Investigational Site
Obihiro
Boehringer Ingelheim Investigational Site
Ōbu
Boehringer Ingelheim Investigational Site
Odawara
Boehringer Ingelheim Investigational Site
Ōgaki
Boehringer Ingelheim Investigational Site
Ōkuchi
Boehringer Ingelheim Investigational Site
Osaka
Boehringer Ingelheim Investigational Site
Ōtsu
Boehringer Ingelheim Investigational Site
Saiki
Boehringer Ingelheim Investigational Site
Saitama
Boehringer Ingelheim Investigational Site
Sakai
Boehringer Ingelheim Investigational Site
Sakede
Boehringer Ingelheim Investigational Site
Sapporo
Boehringer Ingelheim Investigational Site
Sayama
Boehringer Ingelheim Investigational Site
Sendai
Boehringer Ingelheim Investigational Site
Shiroishi
Boehringer Ingelheim Investigational Site
Shiroishichō
Boehringer Ingelheim Investigational Site
Shizuoka
Boehringer Ingelheim Investigational Site
Tagawa
Boehringer Ingelheim Investigational Site
Takarazuka
Boehringer Ingelheim Investigational Site
Tokyo Chiyoda-ku
Boehringer Ingelheim Investigational Site
Tokyo Higashiyamato
Boehringer Ingelheim Investigational Site
Tokyo Itabashi-ku
Boehringer Ingelheim Investigational Site
Tokyo Kita-ku
Boehringer Ingelheim Investigational Site
Tokyo Koto-ku
Boehringer Ingelheim Investigational Site
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site
Tokyo Otaku-ku
Boehringer Ingelheim Investigational Site
Tokyo Shinjuku-ku
Boehringer Ingelheim Investigational Site
Tsu
Boehringer Ingelheim Investigational Site
Tsukuba
Boehringer Ingelheim Investigational Site
Ube
Boehringer Ingelheim Investigational Site
Uji
Boehringer Ingelheim Investigational Site
Urayasu
Boehringer Ingelheim Investigational Site
Uruma
Boehringer Ingelheim Investigational Site
Utsunomiya
Boehringer Ingelheim Investigational Site
Yamagata
Boehringer Ingelheim Investigational Site
Yame
Boehringer Ingelheim Investigational Site
Yokohama
Boehringer Ingelheim Investigational Site
Yorocho
Boehringer Ingelheim Investigational Site
Yurihonjō

Other trials in Japan

About this study

Official title: Special Survey Long-term Treatment

Conditions: Pulmonary Disease, Chronic Obstructive
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What is being measured

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

Number of Patients With Adverse Events (AEs)
Number of patients with AEs
Measured: Pre treatment and 52 weeks after the treatment
Number of Patients With Adverse Drug Reactions (ADRs)
Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.
Measured: Pre treatment and 52 weeks after the treatment

Secondary outcomes (2)

Effective Rate of Comprehensive Evaluation
Evaluate from improvement FEV1 (forced expiratory volume in 1 second) and/or Symptoms by Investigator.
Latest time point, at the end of the observation or 1 year after the initiation of treatment, investigator judged and decided "comprehensive evaluation".
"comprehensive evaluation" was classified into 3 category, "improve" "No change+Aggravated" and "Unassessable" by reference to the result of FEV1 and symptoms. The effective rate was derived from rate of "Improvement" in total number of analyzed patients
Measured: 52 weeks
Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks
Difference between Mean of Pre- and each week's forced expiratory volume in 1 second (FEV1) The FEV1 is the volume (Liters) exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity. FEV1 is by far the most frequently used index for assessing airway obstruction, bronchoconstriction or bronchodilatation
Measured: Pre treatment and 52 weeks after the treatment

Timeline

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

Apr 2005Jan 2009

First posted18 Mar 2008 (estimated)
Study startApr 2005
Primary completionJan 2009

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 Pulmonary Disease, Chronic ObstructiveStudies 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: 385 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00638183
Sponsor's protocol ID: 205.315
Status last verified: Jun 2014
First submitted: 11 Mar 2008
Last updated: 19 Jun 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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Special Survey Long-term Treatment
ClinicalTrials.gov ID: NCT00638183
Acronym / sponsor ID: 205.315
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 385 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Jan 2009 (actual)
First posted: 18 Mar 2008 (estimated)
Results: Posted 5 Apr 2010

Clinical summary

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

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: COHORT

Key inclusion criteria (2 listed)

Patients of Chronic Obstructive Pulmonary Disease
Patients were expected to use the product for long period of time

Key exclusion criteria (3 listed)

Patients with glaucoma
Patients with micturition disorder due to prostatic hyperplasia etc.
Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product

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

Primary outcome

Number of Patients With Adverse Events (AEs)
Time frame: Pre treatment and 52 weeks after the treatment
Number of patients with AEs
Number of Patients With Adverse Drug Reactions (ADRs)
Time frame: Pre treatment and 52 weeks after the treatment
Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.

2 secondary outcomes

Effective Rate of Comprehensive Evaluation
Time frame: 52 weeks
Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks
Time frame: Pre treatment and 52 weeks after the treatment

Results and safety

Results posted to the registry on 5 Apr 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 Treatment	385	266

Primary outcome: Number of Patients With Adverse Events (AEs)

Time frame: Pre treatment and 52 weeks after the treatment. Number. Unit: Participants

Measure	Spiriva Treatment n = 373
Value	71

Population analysed: 373 patients were involved in the safety analysis data

Primary outcome: Number of Patients With Adverse Drug Reactions (ADRs)

Time frame: Pre treatment and 52 weeks after the treatment. Number. Unit: Participants

Measure	Spiriva Treatment n = 373
Value	27

Population analysed: 373 patients were involved in the safety analysis data

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spiriva Treatment	33 of 373 (8.8%)	0 of 373 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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 chair

Boehringer Ingelheim

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 89 sites in Japan.

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 2 inclusion and 3 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 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in Japan. 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 5 Apr 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?

Number of Patients With Adverse Events (AEs) (time frame: Pre treatment and 52 weeks after the treatment). The study lists 2 primary outcomes in all. 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 NCT00638183.

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 19 Jun 2014.