AsthmaPhase 3NCT01316380

Efficacy and Safety of 2 Doses of Tiotropium Via Respimat in Adult Patients With Mild Persistent Asthma

A Phase 3 study testing tiotropium 2.5 mcg and tiotropium 5 mcg in people with Asthma, run by Boehringer Ingelheim at 62 sites in 12 countries.

Completed

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

Official record

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Trial summary

The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium compared to placebo over 12 week treatment period. Tiotropium inhalation solution will be delivered via Respimat inhaler and will be examined on top of maintenance inhaled corticosteroid treatment in patients with mild persistent… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Asthma
What is being tested?: tiotropium 2.5 mcg and tiotropium 5 mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 465 participants
Where: 62 sitesin 12 countries
Study dates: Mar 2011to Apr 2012
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 must sign and date an Informed Consent Form consistent with International Conference on Harmonisation -Good Clinical Practice (ICH-GCP) guidelines and local legislation 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 at Visit 1).
Male or female patients aged 18 years or more at Visit 0 and 75 years or less at Visit 0.
All patients must have
at least a 3 months history of asthma at the time of enrolment into the trial. The initial diagnosis of asthma must have been made before the patient's age of 40;
a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)= 60% predicted and = 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
Patient's diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (within 10 minutes pre and 15-30 minutes after 400 µg salbutamol/albuterol) resulting in a FEV1 increase of = 12% and = 200mL. If this is not achieved the reversibility test may be repeated once within two weeks.

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All patients must be symptomatic despite their current maintenance treatment with low doses of inhaled corticosteroids.
All patients must be symptomatic at Visit 1 (screening) and Visit 2 as defined by an Asthma Control Questionnaire (ACQ) mean score of = 1.5.
All patients must have been on maintenance treatment with a low, stable dose of inhaled corticosteroids for at least 4 weeks prior to Visit 1.
Patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment and who have a smoking history of less than 10 pack years ((see Appendix 10.3 for calculation).
Patients must be able to use the Respimat® inhaler correctly.
Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of the e-Diary/peak flow meter (e-Diary-compliance of at least 80% is required; refer to Section 6.2.1 for instructions).
Patients taking a chronic pulmonary medication allowed by the study protocol must be willing to continue this therapy for the entire duration of the study (exception: times of acute disease deterioration).

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) 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 number 1.
Patients requiring more than 10 puffs of rescue medication (salbutamol/albuterol MDI) per 24 hours on 2 consecutive days during the screening period.
Patients with a recent history (i.e. six months or less) of Acute Coronary Syndrome (STEMI, Non-STEMI and Unstable Angina Pectoris).
Patients who have been hospitalised for cardiac failure during the past year.
Patients with any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.

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Patients with lung diseases other than asthma (e.g. COPD).
Patients with known active tuberculosis.
Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. 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 on Investigator's assessment within the past two years.
Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening).
Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the tiotropium inhalation solution.
Pregnant or nursing woman, including female patients with positive beta-HCG test at Visit 1.
Female patients of child-bearing potential not using highly effective method of birth control As defined in ICH (M3).
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 oral or patch beta-adrenergics, systemic, i.e. oral or intravenous corticosteroids, long-acting anticholinergic tiotropium (Spiriva®) within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with depot corticosteroids within six months prior to Visit 1 and/or during the screening period.
Patients who have ever been treated with anti-IgE antibodies.
Patients who have been treated with leukotriene modifiers, systemic anticholinergics, cromolyn sodium or nedocromil sodium and methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with inhaled long acting beta adrenergics and long acting beta adrenergics combination products within four weeks prior to Visit 0 and/or during the screening period.
Patients who have taken an investigational drug within four weeks or six half lives whichever is greater prior to Visit 1.
Patients who have been treated with other non-approved and according to international guidelines not recommended, experimental drugs for routine asthma therapy (e.g. TNFalpha blockers, methotrexate, cyclosporin) within four weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
Current participation in another trial.

Trial locations and contacts

62 sites in 12 countries.

Country

City, postcode or hospital

62 sites in 12 countries

India10 sites

205.442.91011 Boehringer Ingelheim Investigational Site
Ahmedabad
205.442.91005 Boehringer Ingelheim Investigational Site
Bangalore
205.442.91009 Boehringer Ingelheim Investigational Site
Banglore
205.442.91002 Boehringer Ingelheim Investigational Site
Coimbatore
205.442.91003 Boehringer Ingelheim Investigational Site
Coimbatore
205.442.91004 Boehringer Ingelheim Investigational Site
Coimbatore
205.442.91008 Boehringer Ingelheim Investigational Site
Hyderabad
205.442.91007 Boehringer Ingelheim Investigational Site
Jaipur
205.442.91001 Boehringer Ingelheim Investigational Site
Nagpur
205.442.91006 Boehringer Ingelheim Investigational Site
Pune

Other trials in India

Slovakia8 sites

205.442.42105 Boehringer Ingelheim Investigational Site
Bardejov
205.442.42107 Boehringer Ingelheim Investigational Site
Humenné
205.442.42104 Boehringer Ingelheim Investigational Site
Košice
205.442.42102 Boehringer Ingelheim Investigational Site
Nitra
205.442.42101 Boehringer Ingelheim Investigational Site
Nové Zámky
205.442.42108 Boehringer Ingelheim Investigational Site
Poprad
205.442.42106 Boehringer Ingelheim Investigational Site
Spišská Nová Ves
205.442.42103 Boehringer Ingelheim Investigational Site
Topoľčany

Other trials in Slovakia

Hungary7 sites

205.442.36007 Boehringer Ingelheim Investigational Site
Budapest
205.442.36003 Boehringer Ingelheim Investigational Site
Cegléd
205.442.36002 Boehringer Ingelheim Investigational Site
Gödöllö
205.442.36004 Boehringer Ingelheim Investigational Site
Komárom
205.442.36006 Boehringer Ingelheim Investigational Site
Pécs
205.442.36001 Boehringer Ingelheim Investigational Site
Szarvas
205.442.36005 Boehringer Ingelheim Investigational Site
Százhalombatta

Other trials in Hungary

South Korea6 sites

205.442.82006 Boehringer Ingelheim Investigational Site
Cheongju-si
205.442.82002 Boehringer Ingelheim Investigational Site
Gangwon-do
205.442.82001 Boehringer Ingelheim Investigational Site
Seoul
205.442.82003 Boehringer Ingelheim Investigational Site
Seoul
205.442.82004 Boehringer Ingelheim Investigational Site
Seoul
205.442.82005 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

Guatemala5 sites

205.442.50203 Boehringer Ingelheim Investigational Site
Guatemala City
205.442.50204 Boehringer Ingelheim Investigational Site
Guatemala City
205.442.50201 Boehringer Ingelheim Investigational Site
Nivel Guatemala
205.442.50202 Boehringer Ingelheim Investigational Site
Nivel Guatemala
205.442.50205 Boehringer Ingelheim Investigational Site
Vila Hermosa I

Other trials in Guatemala

Poland5 sites

205.442.48003 Boehringer Ingelheim Investigational Site
Giżycko
205.442.48002 Boehringer Ingelheim Investigational Site
Gorzów Wielkopolski
205.442.48005 Boehringer Ingelheim Investigational Site
Krakow
205.442.48004 Boehringer Ingelheim Investigational Site
Ostrow Wielkopolska
205.442.48001 Boehringer Ingelheim Investigational Site
Poznan

Other trials in Poland

Croatia4 sites

205.442.38502 Boehringer Ingelheim Investigational Site
Rijeka
205.442.38501 Boehringer Ingelheim Investigational Site
Split
205.442.38503 Boehringer Ingelheim Investigational Site
Split
205.442.38504 Boehringer Ingelheim Investigational Site
Zagreb

Other trials in Croatia

Italy4 sites

205.442.39007 Boehringer Ingelheim Investigational Site
Acquaviva Delle Fonti (BA)
205.442.39006 Boehringer Ingelheim Investigational Site
Cagliari
205.442.39003 Boehringer Ingelheim Investigational Site
Chieti
205.442.39001 Boehringer Ingelheim Investigational Site
Pisa

Other trials in Italy

Latvia4 sites

205.442.37101 Boehringer Ingelheim Investigational Site
Baldone
205.442.37103 Boehringer Ingelheim Investigational Site
Daugavpils
205.442.37104 Boehringer Ingelheim Investigational Site
Daugavpils
205.442.37102 Boehringer Ingelheim Investigational Site
Talsi

Other trials in Latvia

Argentina3 sites

205.442.54002 Boehringer Ingelheim Investigational Site
Capital Federal
205.442.54005 Boehringer Ingelheim Investigational Site
Capital Federal
205.442.54003 Boehringer Ingelheim Investigational Site
San Juan Bautista

Other trials in Argentina

Austria3 sites

205.442.43002 Boehringer Ingelheim Investigational Site
Linz
205.442.43003 Boehringer Ingelheim Investigational Site
Schlüsslberg
205.442.43001 Boehringer Ingelheim Investigational Site
Wels

Other trials in Austria

Estonia3 sites

205.442.37203 Boehringer Ingelheim Investigational Site
Kohtla-Järve
205.442.37201 Boehringer Ingelheim Investigational Site
Rakvere
205.442.37202 Boehringer Ingelheim Investigational Site
Tartu

Other trials in Estonia

About this study

Official title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 ug and 5 ug Once Daily) Compared to Placebo Over 12 Weeks in Mild Persistent Asthma

Conditions: Asthma
Being tested: placebo, tiotropium 2.5 mcg, tiotropium 5 mcg
Medical subject headings: Asthma

What participants receive

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

placeboDrug
To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
tiotropium 2.5 mcgDrug
To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
tiotropium 5 mcgDrug
To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler

Study groups in NCT01316380
Study group	Role	What they receive
tiotropium 5 mcg	Experimental	once daily delivered via Respimat inhaler Receives: Drug: tiotropium 5 mcg
tiotropium 2.5 mcg	Experimental	once daily delivered via Respimat inhaler Receives: Drug: tiotropium 2.5 mcg
placebo	Placebo comparator	once daily delivered via Respimat inhaler Receives: Drug: placebo

What is being measured

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

Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.
Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.
Measured: Baseline and 12 weeks

Secondary outcomes (10)

Trough FEV1 Response Determined After a Treatment Period of 12 Weeks.
The trough FEV1 is defined as the pre-dose FEV1 measured 10 minutes before the last administration of randomised treatment. Trough FEV1 response was defined as the difference between the trough FEV1 measured after a treatment period of 12 weeks and the trough FEV1 baseline measurement. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.
Measured: Baseline and 12 weeks
Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.
Peak FVC 0-3h response was defined as the difference between the maximum FVC measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FVC baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.
Measured: Baseline and 12 weeks
FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.
The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FEV1 AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.
Measured: Baseline and 12 weeks
FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.
The AUC0-3h was calculated as area under the curve from zero to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. The trough value was assigned to zero time. Response was defined as change from baseline in FVC AUC0-3h after a treatment period of 12 weeks. MMRM results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit baseline*visit.
Measured: Baseline and 12 weeks
Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment
For the ACQ, the total score was calculated as the mean of the responses to 6 self administered questions and one question which was completed by clinical staff based upon pre-bronchodilator FEV1. The score ranges from 0 (no impairment) to 6 (maximum impairment). Response was categorised as: responder (change from baseline <= -0.5), no change (-0.5 <change from baseline < 0.5) and worsening (change from baseline >= 0.5).
Measured: 12 weeks
Time to First Severe Asthma Exacerbation During the 12-week Treatment.
Severe asthma exacerbations are defined as all asthma exacerbations that required treatment with systemic (including oral) corticosteroids for at least 3 days.
Measured: 12 weeks
Time to First Asthma Exacerbation During the 12-week Treatment.
An asthma exacerbation was defined as an episode of progressive increase in 1 or more asthma symptom that were outside the patient's usual range of day-to-day asthma symptoms and lasted for at least 2 consecutive days or as a decrease in a patient's best morning PEF of 30% or more from a patient's mean morning PEF for at least 2 consecutive days that may or may not have been accompanied by symptoms.
Measured: 12 weeks
Use of Rescue Medication During 24h Period
Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during 24 h period), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.
Measured: Baseline and 12 weeks
Use of Rescue Medication During Daytime
Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during daytime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.
Measured: Baseline and 12 weeks
Use of Rescue Medication During Nighttime
Use of PRN (pro re nata, or as necessary) salbutamol/albuterol rescue medication (puffs during nighttime), determined as a weekly mean response from baseline for each week during the treatment period as well as for the last 7 days before treatment stop/Visit 5.
The mean was adjusted for treatment, centre, week, baseline, treatment*week and baseline*week.
Measured: Baseline and 12 weeks

Timeline

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

Mar 2011Apr 2012

First posted16 Mar 2011 (estimated)
Study startMar 2011
Primary completionApr 2012
Study completionApr 2012

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 (4)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: 465 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01316380
Sponsor's protocol ID: 205.442
Other IDs: 2010-023112-14
Status last verified: Mar 2015
First submitted: 15 Mar 2011
Last updated: 15 Apr 2015
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, Hamelmann EH, Frith PA, Moroni-Zentgraf PM, van Hecke B, Unseld A, Kerstjens HAM, Szefler SJ. Comparative Responses in Lung Function Measurements with Tiotropium in Adolescents and Adults, and Across Asthma Severities: A Post Hoc Analysis. Pulm Ther. 2020 Jun;6(1):131-140. doi: 10.1007/s41030-020-00113-w. Epub 2020 Mar 16.
PubMed 32180164
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
Paggiaro P, Halpin DM, Buhl R, Engel M, Zubek VB, Blahova Z, Moroni-Zentgraf P, Pizzichini E. The Effect of Tiotropium in Symptomatic Asthma Despite Low- to Medium-Dose Inhaled Corticosteroids: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2016 Jan-Feb;4(1):104-13.e2. doi: 10.1016/j.jaip.2015.08.017. Epub 2015 Nov 7.
PubMed 26563670

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?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2015. 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 Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 ug and 5 ug Once Daily) Compared to Placebo Over 12 Weeks in Mild Persistent Asthma
ClinicalTrials.gov ID: NCT01316380
Acronym / sponsor ID: 205.442
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 465 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Mar 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 16 Mar 2011 (estimated)
Results: Posted 31 Jul 2013

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 5 mcg	Experimental	Drug: tiotropium 5 mcgonce daily delivered via Respimat inhaler
tiotropium 2.5 mcg	Experimental	Drug: tiotropium 2.5 mcgonce daily delivered via Respimat inhaler
placebo	Placebo comparator	Drug: placeboonce daily delivered via Respimat inhaler

Who may qualify

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

Key inclusion criteria (13 listed)

All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation -Good Clinical Practice (ICH-GCP) guidelines and local legislation 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 at Visit 1).
Male or female patients aged 18 years or more at Visit 0 and 75 years or less at Visit 0.
All patients must have
at least a 3 months history of asthma at the time of enrolment into the trial. The initial diagnosis of asthma must have been made before the patient's age of 40;
a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)= 60% predicted and = 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.

Key exclusion criteria (25 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) 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 number 1.
Patients requiring more than 10 puffs of rescue medication (salbutamol/albuterol MDI) per 24 hours on 2 consecutive days during the screening period.
Patients with a recent history (i.e. six months or less) of Acute Coronary Syndrome (STEMI, Non-STEMI and Unstable Angina Pectoris).
Patients who have been hospitalised for cardiac failure during the past year.

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
placeboTo evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler	Drug	placebo
tiotropium 2.5 mcgTo evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler	Drug	tiotropium 2.5 mcg
tiotropium 5 mcgTo evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler	Drug	tiotropium 5 mcg

Primary outcome

Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.
Time frame: Baseline and 12 weeks
Peak FEV1 0-3h response was defined as the difference between the maximum FEV1 measured within the first 3 hours post dosing after a treatment period of 12 weeks and the FEV1 baseline measurement (10 minutes before the first dose of trial medication). Mixed Model Repeated Measure (MMRM) results. Means are adjusted for treatment, pooled centre, visit, baseline, treatment*visit and baseline*visit.

10 secondary outcomes

Trough FEV1 Response Determined After a Treatment Period of 12 Weeks.
Time frame: Baseline and 12 weeks
Peak (Within 3 Hours Post-dosing) Forced Vital Capacity (FVC) Response at the End of the 12-week Treatment Period.
Time frame: Baseline and 12 weeks
FEV1 Area Under the Curve (AUC0-3h) Response at the End of the 12-week Treatment Period.
Time frame: Baseline and 12 weeks
FVC (AUC0-3h) Response at the End of the 12-week Treatment Period.
Time frame: Baseline and 12 weeks
Asthma Control Questionnaire (ACQ) Responder After 12 Weeks of Treatment
Time frame: 12 weeks
Time to First Severe Asthma Exacerbation During the 12-week Treatment.
Time frame: 12 weeks
Time to First Asthma Exacerbation During the 12-week Treatment.
Time frame: 12 weeks
Use of Rescue Medication During 24h Period
Time frame: Baseline and 12 weeks
Use of Rescue Medication During Daytime
Time frame: Baseline and 12 weeks
Use of Rescue Medication During Nighttime
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 31 Jul 2013, 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	156	154
Tio R2.5	154	149
Tio R5	155	152

Primary outcome: Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks.

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: Liter

Measure	Placebo n = 154	Tio R2.5 n = 151	Tio R5 n = 152
Value	0.134 (0.026)	0.293 (0.026)	0.262 (0.026)

Placebo vs Tio R5: Mean Difference (Final Values): 0.128 (95% CI 0.057 to 0.199), p = 0.0005, Mixed Models Analysis
Placebo vs Tio R2.5: Mean Difference (Final Values): 0.159 (95% CI 0.088 to 0.230), p <0.0001, Mixed Models Analysis

Population analysed: All patients from Full Analysis Set (FAS) FAS is defined as all patients in the treated set who received at least one dose of randomized trial medication.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 155 (0.6%)	25 of 155 (16.1%)	Not reported
Tio R2.5	0 of 154 (0%)	30 of 154 (19.5%)	Not reported
Tio R5	1 of 155 (0.6%)	21 of 155 (13.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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 32180164Halpin DMG, Hamelmann EH, Frith PA, Moroni-Zentgraf PM, van Hecke B, Unseld A, Kerstjens HAM, Szefler SJ. Comparative Responses in Lung Function Measurements with Tiotropium in Adolescents and Adults, and Across Asthma Severities: A Post Hoc Analysis. Pulm Ther. 2020 Jun;6(1):131-140. doi: 10.1007/s41030-020-00113-w. Epub 2020 Mar 16.
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 26563670Paggiaro P, Halpin DM, Buhl R, Engel M, Zubek VB, Blahova Z, Moroni-Zentgraf P, Pizzichini E. The Effect of Tiotropium in Symptomatic Asthma Despite Low- to Medium-Dose Inhaled Corticosteroids: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2016 Jan-Feb;4(1):104-13.e2. doi: 10.1016/j.jaip.2015.08.017. Epub 2015 Nov 7.

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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

62 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tiotropium 2.5 mcg and tiotropium 5 mcg in people with Asthma, run by Boehringer Ingelheim at 62 sites in 12 countries.

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 13 inclusion and 25 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in India, Slovakia, Hungary, South Korea, Guatemala and 7 more countries. 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 31 Jul 2013). 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?

Peak Forced Expiratory Volume in 1 Second (FEV1) Response Within 3 Hours Post Dosing (0-3h) After a Treatment Period of 12 Weeks. (time frame: Baseline and 12 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 NCT01316380, which also lists 4 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 15 Apr 2015.