Pulmonary Disease, Chronic ObstructiveCOPDNCT02177318

Tiotropium in the Treatment of the Patients With Chronic Obstructive Pulmonary Disease

An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 418 sites in Japan.

Completed

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

Trial summary

To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings Read more about this study

Who is it for?: Any age
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Spiriva (tiotropium bromide) inhalation capsules
Type of treatment: Pill or oral medicine
How many people: 3,588 participants
Where: 418 sitesJapan
Study dates: Apr 2005to Sep 2007
Phase: Observational
Are there results?: None posted in the registry

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: COPD patients in daily clinical settings.

Who may be able to join

Patients with COPD

Who cannot join

-There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice

Trial locations and contacts

418 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Japan300 sites

Boehringer Ingelheim Investigational Site
Abashiri
Boehringer Ingelheim Investigational Site
Aizu-Wakamatsu
Boehringer Ingelheim Investigational Site
Aizubangemachi
Boehringer Ingelheim Investigational Site
Aizumisatomachi
Boehringer Ingelheim Investigational Site
Akashi
Boehringer Ingelheim Investigational Site
Akita
Boehringer Ingelheim Investigational Site
Akō
Boehringer Ingelheim Investigational Site
Amagasaki
Boehringer Ingelheim Investigational Site
Amakusa
Boehringer Ingelheim Investigational Site
Amimachi
Boehringer Ingelheim Investigational Site
Anan
Boehringer Ingelheim Investigational Site
Anjo
Boehringer Ingelheim Investigational Site
Arakawamachi
Boehringer Ingelheim Investigational Site
Arao
Boehringer Ingelheim Investigational Site
Aritacho
Boehringer Ingelheim Investigational Site
Asahikawa
Boehringer Ingelheim Investigational Site
Ashikaga
Boehringer Ingelheim Investigational Site
Atami
Boehringer Ingelheim Investigational Site
Atsugi
Boehringer Ingelheim Investigational Site
Awa
Boehringer Ingelheim Investigational Site
Ayabe
Boehringer Ingelheim Investigational Site
Ayagawacho
Boehringer Ingelheim Investigational Site
Ayase
Boehringer Ingelheim Investigational Site
Beppu
Boehringer Ingelheim Investigational Site
Bibai
Boehringer Ingelheim Investigational Site
Bungoohno
Boehringer Ingelheim Investigational Site
Chiba
Boehringer Ingelheim Investigational Site
Chigasaki
Boehringer Ingelheim Investigational Site
Chikusei
Boehringer Ingelheim Investigational Site
Chikushino-shi
Boehringer Ingelheim Investigational Site
Chitose
Boehringer Ingelheim Investigational Site
Date
Boehringer Ingelheim Investigational Site
Ebetsu
Boehringer Ingelheim Investigational Site
Echizen
Boehringer Ingelheim Investigational Site
Emukaecho
Boehringer Ingelheim Investigational Site
Engarucho
Boehringer Ingelheim Investigational Site
Fuchū
Boehringer Ingelheim Investigational Site
Fuji
Boehringer Ingelheim Investigational Site
Fujiidera
Boehringer Ingelheim Investigational Site
Fujikawaguchiko
Boehringer Ingelheim Investigational Site
Fujinomiya
Boehringer Ingelheim Investigational Site
Fukagawa
Boehringer Ingelheim Investigational Site
Fukaya
Boehringer Ingelheim Investigational Site
Fukuchiyama
Boehringer Ingelheim Investigational Site
Fukui
Boehringer Ingelheim Investigational Site
Fukuoka
Boehringer Ingelheim Investigational Site
Fukuroi
Boehringer Ingelheim Investigational Site
Fukushima
Boehringer Ingelheim Investigational Site
Fukutsu
Boehringer Ingelheim Investigational Site
Fukuyama
Boehringer Ingelheim Investigational Site
Funabashi
Boehringer Ingelheim Investigational Site
Futabamachi
Boehringer Ingelheim Investigational Site
Geiseimura
Boehringer Ingelheim Investigational Site
Gifu
Boehringer Ingelheim Investigational Site
Ginowan
Boehringer Ingelheim Investigational Site
Gobō
Boehringer Ingelheim Investigational Site
Gosen
Boehringer Ingelheim Investigational Site
Gotemba
Boehringer Ingelheim Investigational Site
Gyouda
Boehringer Ingelheim Investigational Site
Habikino
Boehringer Ingelheim Investigational Site
Hachinohe
Boehringer Ingelheim Investigational Site
Hachirogatamachi
Boehringer Ingelheim Investigational Site
Hagi
Boehringer Ingelheim Investigational Site
Hakodate
Boehringer Ingelheim Investigational Site
Hakusan
Boehringer Ingelheim Investigational Site
Hamada
Boehringer Ingelheim Investigational Site
Hamamatsu
Boehringer Ingelheim Investigational Site
Handa
Boehringer Ingelheim Investigational Site
Hanyū
Boehringer Ingelheim Investigational Site
Hatsukaichi
Boehringer Ingelheim Investigational Site
Hayashimacho
Boehringer Ingelheim Investigational Site
Higashihiroshima
Boehringer Ingelheim Investigational Site
Higashimatsushima
Boehringer Ingelheim Investigational Site
Higashiōmi
Boehringer Ingelheim Investigational Site
Higashiosaka
Boehringer Ingelheim Investigational Site
Hikari
Boehringer Ingelheim Investigational Site
Himeji
Boehringer Ingelheim Investigational Site
Hirakata
Boehringer Ingelheim Investigational Site
Hiratsuka
Boehringer Ingelheim Investigational Site
Hirosaki
Boehringer Ingelheim Investigational Site
Hiroshima
Boehringer Ingelheim Investigational Site
Hita
Boehringer Ingelheim Investigational Site
Hitachi
Boehringer Ingelheim Investigational Site
Hitoyoshi
Boehringer Ingelheim Investigational Site
Hōfu
Boehringer Ingelheim Investigational Site
Iamabari
Boehringer Ingelheim Investigational Site
Ibaraki
Boehringer Ingelheim Investigational Site
Ibarakimachi
Boehringer Ingelheim Investigational Site
Ibigawacho
Boehringer Ingelheim Investigational Site
Ibusuki
Boehringer Ingelheim Investigational Site
Ichihara
Boehringer Ingelheim Investigational Site
Ichinomiya
Boehringer Ingelheim Investigational Site
Ichinoseki
Boehringer Ingelheim Investigational Site
Iga
Boehringer Ingelheim Investigational Site
Iida
Boehringer Ingelheim Investigational Site
Iizuka
Boehringer Ingelheim Investigational Site
Ikoma
Boehringer Ingelheim Investigational Site
Imari
Boehringer Ingelheim Investigational Site
Imizu
Boehringer Ingelheim Investigational Site
Ina
Boehringer Ingelheim Investigational Site
Inazawa
Boehringer Ingelheim Investigational Site
Inuyama
Boehringer Ingelheim Investigational Site
Isahaya
Boehringer Ingelheim Investigational Site
Ise
Boehringer Ingelheim Investigational Site
Isehara
Boehringer Ingelheim Investigational Site
Ishikari
Boehringer Ingelheim Investigational Site
Ishinomaki
Boehringer Ingelheim Investigational Site
Itami
Boehringer Ingelheim Investigational Site
Itanocho
Boehringer Ingelheim Investigational Site
Itō
Boehringer Ingelheim Investigational Site
Iwaki
Boehringer Ingelheim Investigational Site
Iwakuni
Boehringer Ingelheim Investigational Site
Iwamizawa
Boehringer Ingelheim Investigational Site
Iwanaicho
Boehringer Ingelheim Investigational Site
Iwata
Boehringer Ingelheim Investigational Site
Iyo
Boehringer Ingelheim Investigational Site
Izu
Boehringer Ingelheim Investigational Site
Izumisano
Boehringer Ingelheim Investigational Site
Izumo
Boehringer Ingelheim Investigational Site
Izunokuni
Boehringer Ingelheim Investigational Site
Jimokujicho
Boehringer Ingelheim Investigational Site
Jōsō
Boehringer Ingelheim Investigational Site
Jouetsu
Boehringer Ingelheim Investigational Site
Jōyō
Boehringer Ingelheim Investigational Site
Kaga
Boehringer Ingelheim Investigational Site
Kagoshima
Boehringer Ingelheim Investigational Site
Kaizuka
Boehringer Ingelheim Investigational Site
Kajikicho
Boehringer Ingelheim Investigational Site
Kakegawa
Boehringer Ingelheim Investigational Site
Kami
Boehringer Ingelheim Investigational Site
Kamiamakusa
Boehringer Ingelheim Investigational Site
Kamisu
Boehringer Ingelheim Investigational Site
Kan’onjichō
Boehringer Ingelheim Investigational Site
Kanazawa
Boehringer Ingelheim Investigational Site
Kandamachi
Boehringer Ingelheim Investigational Site
Kasai
Boehringer Ingelheim Investigational Site
Kasama
Boehringer Ingelheim Investigational Site
Kasaoka
Boehringer Ingelheim Investigational Site
Kashihara
Boehringer Ingelheim Investigational Site
Kashima
Boehringer Ingelheim Investigational Site
Kashiwazaki
Boehringer Ingelheim Investigational Site
Kasuga
Boehringer Ingelheim Investigational Site
Kasuigai
Boehringer Ingelheim Investigational Site
Kasukabe
Boehringer Ingelheim Investigational Site
Kasuyamachi
Boehringer Ingelheim Investigational Site
Katō
Boehringer Ingelheim Investigational Site
Katsuyama
Boehringer Ingelheim Investigational Site
Kawachi-Nagano
Boehringer Ingelheim Investigational Site
Kawagoe
Boehringer Ingelheim Investigational Site
Kawaguchi
Boehringer Ingelheim Investigational Site
Kawanishimachi
Boehringer Ingelheim Investigational Site
Kawasaki
Boehringer Ingelheim Investigational Site
Kayano
Boehringer Ingelheim Investigational Site
Kazuno
Boehringer Ingelheim Investigational Site
Kinkōchō
Boehringer Ingelheim Investigational Site
Kitakami
Boehringer Ingelheim Investigational Site
Kitakyushu
Boehringer Ingelheim Investigational Site
Kitami
Boehringer Ingelheim Investigational Site
Kobe
Boehringer Ingelheim Investigational Site
Kochi
Boehringer Ingelheim Investigational Site
Koga
Boehringer Ingelheim Investigational Site
Komonocho
Boehringer Ingelheim Investigational Site
Kōnan
Boehringer Ingelheim Investigational Site
Kōriyama
Boehringer Ingelheim Investigational Site
Kōshi
Boehringer Ingelheim Investigational Site
Kouriyama
Boehringer Ingelheim Investigational Site
Koushu
Boehringer Ingelheim Investigational Site
Kozakaichō
Boehringer Ingelheim Investigational Site
Kudamatsu
Boehringer Ingelheim Investigational Site
Kumamoto
Boehringer Ingelheim Investigational Site
Kunimimachi
Boehringer Ingelheim Investigational Site
Kunisaki
Boehringer Ingelheim Investigational Site
Kurashiki
Boehringer Ingelheim Investigational Site
Kurayoshi
Boehringer Ingelheim Investigational Site
Kure
Boehringer Ingelheim Investigational Site
Kurihara
Boehringer Ingelheim Investigational Site
Kurume
Boehringer Ingelheim Investigational Site
Kushiro
Boehringer Ingelheim Investigational Site
Kuwana
Boehringer Ingelheim Investigational Site
Kyōtango
Boehringer Ingelheim Investigational Site
Kyoto
Boehringer Ingelheim Investigational Site
Maebashi
Boehringer Ingelheim Investigational Site
Marugame
Boehringer Ingelheim Investigational Site
Masuda
Boehringer Ingelheim Investigational Site
Matsudo
Boehringer Ingelheim Investigational Site
Matsue
Boehringer Ingelheim Investigational Site
Matsumoto
Boehringer Ingelheim Investigational Site
Matsusaka
Boehringer Ingelheim Investigational Site
Matsuyama
Boehringer Ingelheim Investigational Site
Mibumachi
Boehringer Ingelheim Investigational Site
Mihamacho
Boehringer Ingelheim Investigational Site
Mihara
Boehringer Ingelheim Investigational Site
Minamisatsuma
Boehringer Ingelheim Investigational Site
Minamisouma
Boehringer Ingelheim Investigational Site
Minamiuonuma
Boehringer Ingelheim Investigational Site
Mino
Boehringer Ingelheim Investigational Site
Minoh
Boehringer Ingelheim Investigational Site
Misasacho
Boehringer Ingelheim Investigational Site
Misato
Boehringer Ingelheim Investigational Site
Mishima
Boehringer Ingelheim Investigational Site
Mito
Boehringer Ingelheim Investigational Site
Miyakicho
Boehringer Ingelheim Investigational Site
Miyakonojō
Boehringer Ingelheim Investigational Site
Miyazaki
Boehringer Ingelheim Investigational Site
Miyoshi
Boehringer Ingelheim Investigational Site
Mizunami
Boehringer Ingelheim Investigational Site
Mobara
Boehringer Ingelheim Investigational Site
Moriguchi
Boehringer Ingelheim Investigational Site
Morioka
Boehringer Ingelheim Investigational Site
Muroran
Boehringer Ingelheim Investigational Site
Nabari
Boehringer Ingelheim Investigational Site
Nagahama
Boehringer Ingelheim Investigational Site
Nagano
Boehringer Ingelheim Investigational Site
Nagaoka
Boehringer Ingelheim Investigational Site
Nagasaki
Boehringer Ingelheim Investigational Site
Nagato
Boehringer Ingelheim Investigational Site
Nago
Boehringer Ingelheim Investigational Site
Nagoya
Boehringer Ingelheim Investigational Site
Naha
Boehringer Ingelheim Investigational Site
Nakama
Boehringer Ingelheim Investigational Site
Nakashibetsucho
Boehringer Ingelheim Investigational Site
Nanao
Boehringer Ingelheim Investigational Site
Nankoku
Boehringer Ingelheim Investigational Site
Nantan
Boehringer Ingelheim Investigational Site
Nara
Boehringer Ingelheim Investigational Site
Narutō
Boehringer Ingelheim Investigational Site
Nasukarasuyama
Boehringer Ingelheim Investigational Site
Neyagawa
Boehringer Ingelheim Investigational Site
Nihonmatsu
Boehringer Ingelheim Investigational Site
Niigata
Boehringer Ingelheim Investigational Site
Niihamashi
Boehringer Ingelheim Investigational Site
Nikkō
Boehringer Ingelheim Investigational Site
Nishiiyo
Boehringer Ingelheim Investigational Site
Nishinomiya
Boehringer Ingelheim Investigational Site
Nishio
Boehringer Ingelheim Investigational Site
Nobeoka
Boehringer Ingelheim Investigational Site
Noboribetsu
Boehringer Ingelheim Investigational Site
Noda
Boehringer Ingelheim Investigational Site
Nomi
Boehringer Ingelheim Investigational Site
Noshiro
Boehringer Ingelheim Investigational Site
Notōchō
Boehringer Ingelheim Investigational Site
Numata
Boehringer Ingelheim Investigational Site
Numazu
Boehringer Ingelheim Investigational Site
Oaraimachi
Boehringer Ingelheim Investigational Site
Obama
Boehringer Ingelheim Investigational Site
Obihiro
Boehringer Ingelheim Investigational Site
Ōdate
Boehringer Ingelheim Investigational Site
Odawara
Boehringer Ingelheim Investigational Site
Ogawaramachi
Boehringer Ingelheim Investigational Site
Ogi
Boehringer Ingelheim Investigational Site
Ōita
Boehringer Ingelheim Investigational Site
Ojiya
Boehringer Ingelheim Investigational Site
Okayama
Boehringer Ingelheim Investigational Site
Okinawa
Boehringer Ingelheim Investigational Site
Ōmihachiman
Boehringer Ingelheim Investigational Site
Omuta
Boehringer Ingelheim Investigational Site
Ōnomachi
Boehringer Ingelheim Investigational Site
Osaka
Boehringer Ingelheim Investigational Site
Ōta-ku
Boehringer Ingelheim Investigational Site
Ōtake
Boehringer Ingelheim Investigational Site
Otaru
Boehringer Ingelheim Investigational Site
Ōtsu
Boehringer Ingelheim Investigational Site
Ōtsumachi
Boehringer Ingelheim Investigational Site
Owariasahi
Boehringer Ingelheim Investigational Site
Rittō
Boehringer Ingelheim Investigational Site
Ryūgasaki
Boehringer Ingelheim Investigational Site
Sado
Boehringer Ingelheim Investigational Site
Saga
Boehringer Ingelheim Investigational Site
Sagamihara
Boehringer Ingelheim Investigational Site
Saiki
Boehringer Ingelheim Investigational Site
Saitama
Boehringer Ingelheim Investigational Site
Sakacho
Boehringer Ingelheim Investigational Site
Sakai
Boehringer Ingelheim Investigational Site
Sakaimachi
Boehringer Ingelheim Investigational Site
Sakaiminato
Boehringer Ingelheim Investigational Site
Sakata
Boehringer Ingelheim Investigational Site
Saku
Boehringer Ingelheim Investigational Site
Sanjyo
Boehringer Ingelheim Investigational Site
Sanuki
Boehringer Ingelheim Investigational Site
Sanyōonoda
Boehringer Ingelheim Investigational Site
Sapporo
Boehringer Ingelheim Investigational Site
Sasayama
Boehringer Ingelheim Investigational Site
Sasebo
Boehringer Ingelheim Investigational Site
Sayama
Boehringer Ingelheim Investigational Site
Sayama
Boehringer Ingelheim Investigational Site
Sendai
Boehringer Ingelheim Investigational Site
Sendai
Boehringer Ingelheim Investigational Site
Sennan
Boehringer Ingelheim Investigational Site
Shibetsu
Boehringer Ingelheim Investigational Site
Shibukawa
Boehringer Ingelheim Investigational Site
Shimada
Boehringer Ingelheim Investigational Site
Shimonoseki
Boehringer Ingelheim Investigational Site
Shimotsuke
Boehringer Ingelheim Investigational Site
Shimotsuma
Boehringer Ingelheim Investigational Site
Shingū
Boehringer Ingelheim Investigational Site
Shiogama
Boehringer Ingelheim Investigational Site
Shirahamachō
Boehringer Ingelheim Investigational Site
Shiroishi
Boehringer Ingelheim Investigational Site
Shiroishichō
Boehringer Ingelheim Investigational Site
Shizuoka

Other trials in Japan

About this study

Official title: Drug Use Results Survey of Tiotropium Bromide

To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Spiriva (tiotropium bromide) inhalation capsules
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.

Spiriva (tiotropium bromide) inhalation capsulesDrug
Survey of patients with COPD using Spiriva (tiotropium bromide) inhalation capsules

Study groups in NCT02177318
Study group	Role	What they receive
Patients with COPD		Not described Receives: Drug: Spiriva (tiotropium bromide) inhalation capsules

What is being measured

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

Number of patients with adverse events
Measured: Up to 4 weeks after start of treatment
Number of patients with adverse drug reactions
Measured: Up to 4 weeks after start of treatment
Number of patients with serious adverse events
Measured: Up to 4 weeks after start of treatment

Secondary outcomes (1)

Physician's overall judgement by medical interview into four grades: 1. Improved 2. No Change 3. Aggravated 4.Unassessable
Measured: Up to 4 weeks after start of treatment

Timeline

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

Apr 2005Sep 2007

First posted27 Jun 2014 (estimated)
Study startApr 2005
Primary completionSep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 3,588 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02177318
Sponsor's protocol ID: 205.314
Acronym: COPD
Status last verified: Jun 2014
First submitted: 31 Jan 2008
Last updated: 27 Jun 2014
Results posted: No

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 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Drug Use Results Survey of Tiotropium Bromide
ClinicalTrials.gov ID: NCT02177318
Acronym / sponsor ID: COPD / 205.314
Conditions: Pulmonary Disease, Chronic Obstructive
Study type: Observational
Recruitment status: Completed
Enrolment: 3,588 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Sep 2007 (actual)
First posted: 27 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

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

To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with COPD	–	Drug: Spiriva (tiotropium bromide) inhalation capsules

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: COPD patients in daily clinical settings.

Key inclusion criteria (1 listed)

Patients with COPD

Key exclusion criteria (1 listed)

-There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice

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
Spiriva (tiotropium bromide) inhalation capsulesSurvey of patients with COPD using Spiriva (tiotropium bromide) inhalation capsules	Drug	Patients with COPD

Primary outcome

Number of patients with adverse events
Time frame: Up to 4 weeks after start of treatment
Number of patients with adverse drug reactions
Time frame: Up to 4 weeks after start of treatment
Number of patients with serious adverse events
Time frame: Up to 4 weeks after start of treatment

1 secondary outcome

Physician's overall judgement by medical interview into four grades: 1. Improved 2. No Change 3. Aggravated 4.Unassessable
Time frame: Up to 4 weeks after start of treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.

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

418 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 418 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 1 inclusion and 1 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 27 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 418 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: Up to 4 weeks after start of treatment). The study lists 3 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 NCT02177318.

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 27 Jun 2014.