AsthmaPhase 3NCT01340209

Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma

A Phase 3 study testing Tiotropium Respimat in people with Asthma, run by Boehringer Ingelheim at 55 sites in Japan.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Asthma
What is being tested?: Tiotropium Respimat
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 285 participants
Where: 55 sitesJapan
Study dates: Apr 2011to Apr 2013
Phase: Phase 3
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients including the patients under age (under 20 years old) must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and Good Clinical Practice (GCP) prior to participation in the trial [i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test (PFT) at Visit 1]. Regarding patients under age, a guardian or a legally authorised representative must also sign and date an Informed Consent Form.
Male or female outpatients aged at least 18 years but not more than 75 years at Visit 0.
All patients must have at least a 12-week history of asthma at the time of enrolment (Visit 0) into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5.
The initial diagnosis of asthma must have been made before the patient's age of 40.
The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15-30 minutes after 400 µg salbutamol) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200 mL .
All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (ICS) [alone or in a fixed combination with a Long-acting beta-adrenergic (LABA)] for at least 4 weeks prior to Visit 1.

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All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of at least 1.5.
All patients must have a pre-bronchodilator FEV1 at least 60% and less than or equal to 90% of predicted normal at Visit 1.
Patients must be never-smokers or ex-smokers who stopped smoking at least one year (52 weeks) prior to enrolment (Visit 0) and who have a smoking history of less than 10 pack years.
Patients must be able to use the Respimat inhaler correctly, which is judged at the discretion of the investigator..
Patients must be able to perform all trial related procedures including technically acceptable PFTs and use of electronic diary (eDiary)/peak flow meter, which is judged at the discretion of the investigator.

Who cannot join

Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no 1.
Patients with a recent history (i.e. 6 months or less) of myocardial infarction prior to Visit 0.
Patients who have been hospitalised for cardiac failure during the past year prior to Visit 0.
Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year prior to Visit 0.
Patients with lung diseases other than asthma (e.g. COPD).

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Patients with known active tuberculosis.
Patients with malignancy and/or patients who have undergone resection, radiation therapy or chemotherapy for malignancy within the last 5 years prior to Visit 0. Patients with treated basal cell carcinoma are allowed.
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1.
Patients with significant alcohol or drug abuse, which is judged at the discretion of the investigator, within the past 2 years prior to Visit 0.
Patients with known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA), or any other components of the study medication delivery systems.
Pregnant or nursing women.
Women of childbearing potential not using a highly effective method of birth control.
Patients who have taken an investigational drug within 4 weeks prior to Visit 1.
Patients who have been treated with beta-blocker medication within four weeks prior to Visit 1 and/or during the screening period. Topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed.
Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva) within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period.
Patients who have been treated with systemic corticosteroids within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with anti-IgE antibodies, e.g. omalizumab (Xolair®), within 6 months prior to Visit 1 and/or during the screening period.
Patients who have been treated with other non-approved and according to international guidelines not recommended "experimental" drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.
Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 and/or during the screening period.
Patients who are currently participating in another trial.
Patients with narrow-angle glaucoma and/or micturition disorder due to prostatic hyperplasia.
Patients with below 80% of the eDiary completion compliance on Visit 2 (diary compliance of at least 80% is required).

Trial locations and contacts

55 sites in 1 country.

City, postcode or hospital

55 sites in 1 country

Japan55 sites

205.464.81020 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido
205.464.81031 Boehringer Ingelheim Investigational Site
Atsugi, Kanagawa
205.464.81029 Boehringer Ingelheim Investigational Site
Chigasaki, Kanagawa
205.464.81011 Boehringer Ingelheim Investigational Site
Chino, Nagano
205.464.81050 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
205.464.81051 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo
205.464.81006 Boehringer Ingelheim Investigational Site
Edogawa-ku, Tokyo
205.464.81010 Boehringer Ingelheim Investigational Site
Fujisawa, Kanagawa
205.464.81016 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
205.464.81004 Boehringer Ingelheim Investigational Site
Hanno, Saitama
205.464.81040 Boehringer Ingelheim Investigational Site
Himeji, Hyogo
205.464.81041 Boehringer Ingelheim Investigational Site
Himeji, Hyogo
205.464.81053 Boehringer Ingelheim Investigational Site
Himeji, Hyogo
205.464.81007 Boehringer Ingelheim Investigational Site
Hino, Tokyo
205.464.81015 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima
205.464.81002 Boehringer Ingelheim Investigational Site
Hitachinaka, Ibaraki
205.464.81048 Boehringer Ingelheim Investigational Site
Iizuka, Fukuoka
205.464.81005 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo
205.464.81033 Boehringer Ingelheim Investigational Site
Kaga, Ishikawa
205.464.81017 Boehringer Ingelheim Investigational Site
Kagoshima, Kagoshima
205.464.81023 Boehringer Ingelheim Investigational Site
Kamogawa, Chiba
205.464.81024 Boehringer Ingelheim Investigational Site
Kisarazu, Chiba
205.464.81047 Boehringer Ingelheim Investigational Site
Kitakyusyu,Fukuoka
205.464.81008 Boehringer Ingelheim Investigational Site
Kiyose, Tokyo
205.464.81046 Boehringer Ingelheim Investigational Site
Kochi, Kochi
205.464.81025 Boehringer Ingelheim Investigational Site
Kodaira, Tokyo
205.464.81022 Boehringer Ingelheim Investigational Site
Koshigaya, Saitama
205.464.81043 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama
205.464.81044 Boehringer Ingelheim Investigational Site
Kure, Hiroshima
205.464.81014 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
205.464.81038 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
205.464.81003 Boehringer Ingelheim Investigational Site
Maebashi, Gumma
205.464.81042 Boehringer Ingelheim Investigational Site
Matsue, Shimane
205.464.81026 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo
205.464.81012 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
205.464.81013 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
205.464.81034 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
205.464.81035 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
205.464.81036 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
205.464.81037 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
205.464.81001 Boehringer Ingelheim Investigational Site
Obihiro, Hokkaido
205.464.81018 Boehringer Ingelheim Investigational Site
Obihiro, Hokkaido
205.464.81054 Boehringer Ingelheim Investigational Site
Oita, Oita
205.464.81055 Boehringer Ingelheim Investigational Site
Oita, Oita
205.464.81039 Boehringer Ingelheim Investigational Site
Osaka, Osaka
205.464.81049 Boehringer Ingelheim Investigational Site
Saga, Saga
205.464.81019 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
205.464.81021 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
205.464.81028 Boehringer Ingelheim Investigational Site
Setagaya-ku, Tokyo
205.464.81027 Boehringer Ingelheim Investigational Site
Setagaya-Ku, Tokyo
205.464.81045 Boehringer Ingelheim Investigational Site
Toon, Ehime
205.464.81009 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
205.464.81052 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
205.464.81030 Boehringer Ingelheim Investigational Site
Yokosuka, Kanagawa
205.464.81032 Boehringer Ingelheim Investigational Site
Zama

Other trials in Japan

About this study

Official title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma

The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate to severe persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on asthma control, and number of adverse events.

Conditions: Asthma
Being tested: Tiotropium Respimat, Placebo Respimat
Medical subject headings: Asthma

What participants receive

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

Tiotropium RespimatDrug
Tiotropium high dose once daily delivered with Respimat inhaler
Placebo RespimatDrug
Tiotropium placebo once daily delivered with Respimat inhaler
Tiotropium RespimatDrug
Tiotropium low dose once daily delivered with Respimat inhaler

Study groups in NCT01340209
Study group	Role	What they receive
Tiotropium Respimat (low dose)	Experimental	Tiotropium low dose once daily delivered with Respimat inhaler Receives: Drug: Tiotropium Respimat
Tiotropium Respimat (high dose)	Experimental	Tiotropium high dose once daily delivered with Respimat inhaler Receives: Drug: Tiotropium Respimat
Placebo Respimat	Placebo comparator	Tiotropium placebo once daily delivered with Respimat inhaler Receives: Drug: Placebo Respimat

What is being measured

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

Number of Patients With Drug-related Adverse Events
The primary endpoint is the number of patients with drug-related adverse events
Measured: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409

Secondary outcomes (9)

Trough FEV1 Response
Trough FEV1 response was defined as change from baseline at week 52
Measured: baseline and week 52
Trough FVC Response
Trough FVC response was defined as change from baseline at week 52
Measured: baseline and week 52
Trough PEF Response
Trough PEF response was defined as change from baseline at week 52
Measured: baseline and week 52
Weekly Mean PEFam Response
Weekly mean PEFam response was defined as change from baseline at week 52
Measured: baseline and week 52
Weekly Mean PEFpm Response
Weekly mean PEFpm response was defined as change from baseline at week 52
Measured: baseline and week 52
Weekly Mean PEF Variability Response
Weekly mean PEF variability response was defined as change from baseline at week 52.
The PEF variability is the absolute difference between morning and evening PEF value, divided by their mean, expressed as a percent. Response was defined as change from baseline.
Measured: baseline and week 52
Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)
Response of weekly mean number of puffs of rescue medication during the whole day at week 52. Response was defined as change from baseline.
Measured: baseline and week 52
Weekly Mean Score of Asthma Symptoms in the Morning (Response)
Response of weekly mean score of asthma symptoms in the morning at week 52. Response was defined as change from baseline.
5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment.
Measured: baseline and week 52
Weekly Mean Score of Asthma Symptoms During the Day (Response)
Response of weekly mean score of asthma symptoms during the day at week 52. Response was defined as change from baseline.
5-point verbal rating scale, with answer 1 representing no impairment at all and answer 5 representing the greatest impairment.
Measured: baseline and week 52

Timeline

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

Apr 2011Apr 2013

First posted22 Apr 2011 (estimated)
Study startApr 2011
Primary completionApr 2013
Study completionApr 2013

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 285 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340209
Sponsor's protocol ID: 205.464
Status last verified: Jun 2014
First submitted: 13 Apr 2011
Last updated: 4 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162
Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, Engel M, Zaremba-Pechmann L, Casale T, FitzGerald JM. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1. Respir Res. 2019 Jul 18;20(1):159. doi: 10.1186/s12931-019-1119-6.
PubMed 31319851
Ohta K, Ichinose M, Tohda Y, Engel M, Moroni-Zentgraf P, Kunimitsu S, Sakamoto W, Adachi M. Long-Term Once-Daily Tiotropium Respimat(R) Is Well Tolerated and Maintains Efficacy over 52 Weeks in Patients with Symptomatic Asthma in Japan: A Randomised, Placebo-Controlled Study. PLoS One. 2015 Apr 20;10(4):e0124109. doi: 10.1371/journal.pone.0124109. eCollection 2015.
PubMed 25894430

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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Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma
ClinicalTrials.gov ID: NCT01340209
Acronym / sponsor ID: 205.464
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 285 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Apr 2011
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 22 Apr 2011 (estimated)
Results: Posted 4 Jul 2014

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
Tiotropium Respimat (low dose)	Experimental	Drug: Tiotropium RespimatTiotropium low dose once daily delivered with Respimat inhaler
Tiotropium Respimat (high dose)	Experimental	Drug: Tiotropium RespimatTiotropium high dose once daily delivered with Respimat inhaler
Placebo Respimat	Placebo comparator	Drug: Placebo RespimatTiotropium placebo once daily delivered with Respimat inhaler

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

All patients including the patients under age (under 20 years old) must sign and date an Informed Consent Form consistent with ICH-GCP guidelines and Good Clinical Practice (GCP) prior to participation in the trial [i.e. prior to any trial procedures, including any pre-trial washout of medications and medication restrictions for pulmonary function test (PFT) at Visit 1]. Regarding patients under age, a guardian or a legally authorised representative must also sign and date an Informed Consent Form.
Male or female outpatients aged at least 18 years but not more than 75 years at Visit 0.
All patients must have at least a 12-week history of asthma at the time of enrolment (Visit 0) into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion 5.
The initial diagnosis of asthma must have been made before the patient's age of 40.
The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15-30 minutes after 400 µg salbutamol) resulting in a Forced Expiratory Volume in one second (FEV1) increase of at least 12% and at least 200 mL .

Key exclusion criteria (24 listed)

Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.
Patients with a clinically relevant abnormal screening (Visit 1) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no 1.
Patients with a recent history (i.e. 6 months or less) of myocardial infarction prior to Visit 0.
Patients who have been hospitalised for cardiac failure during the past year prior to Visit 0.
Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year prior to Visit 0.

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 RespimatTiotropium high dose once daily delivered with Respimat inhaler	Drug	Tiotropium Respimat (high dose)
Placebo RespimatTiotropium placebo once daily delivered with Respimat inhaler	Drug	Placebo Respimat
Tiotropium RespimatTiotropium low dose once daily delivered with Respimat inhaler	Drug	Tiotropium Respimat (low dose)

Primary outcome

Number of Patients With Drug-related Adverse Events
Time frame: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409
The primary endpoint is the number of patients with drug-related adverse events

9 secondary outcomes

Trough FEV1 Response
Time frame: baseline and week 52
Trough FVC Response
Time frame: baseline and week 52
Trough PEF Response
Time frame: baseline and week 52
Weekly Mean PEFam Response
Time frame: baseline and week 52
Weekly Mean PEFpm Response
Time frame: baseline and week 52
Weekly Mean PEF Variability Response
Time frame: baseline and week 52
Weekly Mean Number of Puffs of Rescue Medication During the Whole Day (Response)
Time frame: baseline and week 52
Weekly Mean Score of Asthma Symptoms in the Morning (Response)
Time frame: baseline and week 52
Weekly Mean Score of Asthma Symptoms During the Day (Response)
Time frame: baseline and week 52

Results and safety

Results posted to the registry on 4 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Respimat	57	52
Tiotropium Respimat (2.5 µg)	114	106
Tiotropium Respimat (5 μg)	114	106

Primary outcome: Number of Patients With Drug-related Adverse Events

Time frame: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409. Number. Unit: participants

Measure	Placebo Respimat n = 57	Tiotropium Respimat (2.5 µg) n = 114	Tiotropium Respimat (5 μg) n = 114
Value	3	6	10

Population analysed: Treated set: all randomised patients who received at least 1 dose of study medication

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Respimat	9 of 57 (15.8%)	50 of 57 (87.7%)	Not reported
Tiotropium Respimat (2.5 µg)	4 of 114 (3.5%)	97 of 114 (85.1%)	Not reported
Tiotropium Respimat (5 μg)	4 of 114 (3.5%)	101 of 114 (88.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Derived from this study: PubMed 31319851Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, Engel M, Zaremba-Pechmann L, Casale T, FitzGerald JM. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1. Respir Res. 2019 Jul 18;20(1):159. doi: 10.1186/s12931-019-1119-6.
Derived from this study: PubMed 25894430Ohta K, Ichinose M, Tohda Y, Engel M, Moroni-Zentgraf P, Kunimitsu S, Sakamoto W, Adachi M. Long-Term Once-Daily Tiotropium Respimat(R) Is Well Tolerated and Maintains Efficacy over 52 Weeks in Patients with Symptomatic Asthma in Japan: A Randomised, Placebo-Controlled Study. PLoS One. 2015 Apr 20;10(4):e0124109. doi: 10.1371/journal.pone.0124109. eCollection 2015.
Related InfoLink provided by the sponsor.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tiotropium Respimat in people with Asthma, run by Boehringer Ingelheim at 55 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 11 inclusion and 24 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 4 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2014). 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 Drug-related Adverse Events (time frame: after the first dose of trial medication and within 30 days after the last dose of trial medication, up to 409). 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 NCT01340209, which also lists 3 linked publications.

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 4 Jul 2014.