AsthmaPhase 2NCT01233284

Randomised, Double- Blind, Cross-over Efficacy and Safety Comparison of Three Different Doses of Tiotropium Administered Once Daily Versus Placebo in Patients With Moderate Persistent Asthma.

A Phase 2 study testing tiotropium bromide 2.5µg once daily, tiotropium bromide high dose once daily and tiotropium bromide 1.25µg once daily in people with Asthma, run by Boehringer Ingelheim at 19 sites in 3 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

Rationale for the current trial is to evaluate the efficacy and safety of three doses (1.25 µg, 2.5 µg and 5.0 µg ex mouthpiece) of tiotropium inhalation solution in patients with moderate persistent asthma who are still symptomatic despite regular maintenance therapy with inhaled corticosteroids (ICS). 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 bromide 2.5µg once daily, tiotropium bromide high dose once daily and tiotropium bromide 1.25µg once daily
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 149 participants
Where: 19 sitesin 3 countries
Study dates: Nov 2010to Jan 2012
Phase: Phase 2
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 the Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) 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 between 18 and 75 years (at date of informed consent).
All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion no. 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 to 30 minutes after 4 puffs of 100 µg salbutamol) resulting in a Forced Expiratory Volume in one second (FEV1) increase of = 12% and = 200mL.
All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (alone or in a fixed combination with a long acting or short acting beta agonist [LABA or SABA]) 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 = 1.5.
All patients must have a pre-bronchodilator FEV1 = 60% and = 90% of predicted normal at Visit 1. Predicted normal values will be calculated according to the European Community for Steel and Coal (ECSC).
Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator) as compared to Visit 2 (pre-dose) must be within ± 30%.
Patients must be never-smokers or ex-smokers who stopped smoking at least one year 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.
Patients must be able to perform all trial related procedures including technically acceptable pulmonary function tests and use of electronic diary/peak flow meter (diary compliance of at least 80% is required).

Who cannot join

Patients with a significant disease other than asthma.
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 1.
Patients with a recent history (i.e. six months or less) of myocardial infarction.
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.
Patients with lung diseases other than asthma.

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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 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 known moderate to severe renal impairment.
Patients with known narrow angle glaucoma or any other disease where anticholinergic treatment is contraindicated.
Patients with significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included.
Patients with significant alcohol or drug abuse within the past two years (to the discretion of the investigator).
Patients who are currently in a pulmonary rehabilitation program or have completed pulmonary rehabilitation program in the 6 weeks prior to Visit 1 (screening) or who will start a rehabilitation program during the study.
Patients with known hypersensitivity to anticholinergic drugs, Benzalkonium chloride (BAC), Ethylenediaminetetraacetate (EDTA) or any other components of the study medication delivery system (Respimat®/ tiotropium inhalation solution).
Pregnant or nursing woman.
Women of childbearing potential not using a highly effective method of birth control.
Patients who have taken an investigational drug within four 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 (period between Visit 1 and Visit 2). Topical cardio-selective beta-blocker eye medications for non-arrow 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 (period between Visit 1 and Visit 2).
Patients who have been treated with oral or patch beta-adrenergics within four weeks prior to Visit 1 and/or during the Screening period (period between Visit 1 and Visit 2)
Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 and/or during the screening period.
Patients who have been treated with anti-Immunoglobuline E (anti-IgE) antibodies, e.g. omalizumab, within 6 months prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
Patients who have been treated with cromone within two weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
Patients who have been treated with methylxanthines or phosphodiesterase 4 inhibitors within two weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
Patients who have been treated with other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy (e.g. Tumor Necrosis Factor (TNF)-alpha blockers, methotrexate, cyclosporin) within four weeks prior to Visit 1 and/or during the screening period (period between Visit 1 and Visit 2).
Patient with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to visit 1 and/or during the screening period.

Trial locations and contacts

19 sites in 3 countries.

Country

City, postcode or hospital

19 sites in 3 countries

Germany9 sites

205.380.49006 Boehringer Ingelheim Investigational Site
Berlin
205.380.49010 Boehringer Ingelheim Investigational Site
Berlin
205.380.49003 Boehringer Ingelheim Investigational Site
Frankfurt
205.380.49004 Boehringer Ingelheim Investigational Site
Hamburg
205.380.49007 Boehringer Ingelheim Investigational Site
Hanover
205.380.49009 Boehringer Ingelheim Investigational Site
Mainz
205.380.49008 Boehringer Ingelheim Investigational Site
Schwerin
205.380.49001 Boehringer Ingelheim Investigational Site
Wiesbaden
205.380.49005 Boehringer Ingelheim Investigational Site
Wiesloch

Other trials in Germany

Austria5 sites

205.380.43002 Boehringer Ingelheim Investigational Site
Hallein
205.380.43004 Boehringer Ingelheim Investigational Site
Linz
205.380.43005 Boehringer Ingelheim Investigational Site
Neumarkt am Wallersee
205.380.43001 Boehringer Ingelheim Investigational Site
Schlüsslberg
205.380.43003 Boehringer Ingelheim Investigational Site
Thalheim bei Wels

Other trials in Austria

Ukraine5 sites

205.380.38005 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk
205.380.38003 Boehringer Ingelheim Investigational Site
Kharkiv
205.380.38004 Boehringer Ingelheim Investigational Site
Kharkiv
205.380.38001 Boehringer Ingelheim Investigational Site
Kiev
205.380.38002 Boehringer Ingelheim Investigational Site
Kiev

Other trials in Ukraine

About this study

Official title: A Phase II Randomised, Double-blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Three Doses of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (1.25, 2.5 and 5.0 Mcg Once Daily) Versus Placebo in Patients With Moderate Persistent Asthma.

The data collected in the present trial will provide useful information to health care providers and patients regarding the efficacy and safety of a once daily inhalation of three different doses of tiotropium solution delivered by the Respimat® inhaler in addition to inhaled corticosteroids in the treatment of not fully controlled moderate asthma in comparison to placebo. The Pharmacokinetics (PK) of tiotropium is well established in COPD patients. However, there is currently no PK data available for the 3 doses of tiotropium being tested in this trial in patients with moderate persistent asthma. Tiotropium is a once daily drug. Hence, the rationale for blood and urine sampling for PK analysis over 24 hours in a subset of patients is to confirm the PK of the 3 doses in moderate asthma patients. Rationale for the 24-hour pulmonary function test sub-investigation is to demonstrate that a once daily dosing of tiotropium inhalation solution is effective and safe in the treatment of moderate persistent asthma.

Conditions: Asthma
Being tested: tiotropium bromide 2.5µg once daily, Tiotropium matching Placebo once daily, tiotropium bromide high dose once daily, tiotropium bromide 1.25µg once daily
Medical subject headings: Asthma

What participants receive

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

tiotropium bromide 2.5µg once dailyDrug
Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
Tiotropium matching Placebo once dailyDrug
Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
tiotropium bromide high dose once dailyDrug
Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
tiotropium bromide 1.25µg once dailyDrug
IMP

Study groups in NCT01233284
Study group	Role	What they receive
tiotropium low dose once daily	Experimental	once daily, delivered by the Respimat® inhaler Receives: Drug: tiotropium bromide 1.25µg once daily
tiotropium medium dose once daily	Experimental	once daily, delivered by the Respimat® inhaler Receives: Drug: tiotropium bromide 2.5µg once daily
tiotropium high dose once daily	Experimental	once daily, delivered by the Respimat® inhaler Receives: Drug: tiotropium bromide high dose once daily
Placebo once daily	Placebo comparator	once daily, delivered by the Respimat® inhaler Receives: Drug: Tiotropium matching Placebo once daily

What is being measured

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

Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response
Mixed model repeated measurement (MMRM) results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
Measured: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration

Secondary outcomes (17)

Trough FEV1 Response
MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 was measured just prior to the last administration of randomised treatment.
Measured: Baseline and 4 weeks
FEV1 Area Under the Curve 0-3 Hours (AUC0-3h) Response
MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.
Measured: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration
Forced Vital Capacity (FVC) Peak Within 0-3 Hours Post-dose Response
MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
Measured: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration
Trough FVC Response
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Trough FVC was measured just prior to the last administration of randomised treatment.
Measured: Baseline and 4 weeks
FVC AUC0-3h Response
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-3h was calculated using the trapezoidal rule divided by the observation time (3 hours) to report in litres.
Measured: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration
Individual FEV1 Over Time (at Each Timepoint at Visits) Response
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
Measured: Baseline and 4 weeks
Individual FVC Over Time (at Each Timepoint at Visits) Response
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
Measured: Baseline and 4 weeks
Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.
Measured: Baseline and 4 weeks
Mean Pre-dose Morning PEF (PEF a.m.) Response During the Last Week on Treatment
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
Measured: Baseline and 4 weeks
Mean Pre-dose Evening PEF (PEF p.m.) Response During the Last Week on Treatment
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
Measured: Baseline and 4 weeks
PEF Variability Response (Last Week on Treatment)
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. PEF variability is the absolute difference between morning and evening PEF value divided by the mean of these two values, expressed as a percent . Weekly means obtained during the last week of each period of randomised treatment will be compared.
Measured: Baseline and 4 weeks
Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
Measured: Baseline and 4 weeks
Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
Measured: Baseline and 4 weeks
Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
Measured: Baseline and 4 weeks
Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)
MMRM results. Response was defined as change from baseline at the end of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. Weekly means obtained during the last week of each period of randomised treatment will be compared (measured by patients at home using the AM2+ device).
Measured: Baseline and 4 weeks
FEV1 Area Under the Curve Within 24 Hours (h) Response (FEV1 AUC0-12h, FEV1 AUC12-24h, FEV1 AUC0-24h)
MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FEV1 AUC0-12, FEV1 AUC12-24 and FEV1 AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.
Measured: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration
FVC Area Under the Curve Within 24 Hours (h) Response (FVC AUC0-12h, FVC AUC12-24h, FVC AUC0-24h)
MMRM results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline. FVC AUC0-12, FVC AUC12-24 and FVC AUC0-24 were calculated using the trapezoidal rule divided by the observation time (12h resp. 24h) to report in litres.
Measured: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration

Timeline

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

Nov 2010Jan 2012

First posted3 Nov 2010 (estimated)
Study startNov 2010
Primary completionJan 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 (1)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01233284
Sponsor's protocol ID: 205.380
Other IDs: 2010-018471-26
Status last verified: Sep 2013
First submitted: 2 Nov 2010
Last updated: 24 Dec 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Beeh KM, Moroni-Zentgraf P, Ablinger O, Hollaenderova Z, Unseld A, Engel M, Korn S. Tiotropium Respimat(R) in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma. Respir Res. 2014 Jun 3;15(1):61. doi: 10.1186/1465-9921-15-61.
PubMed 24890738

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 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Randomised, Double-blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Three Doses of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (1.25, 2.5 and 5.0 Mcg Once Daily) Versus Placebo in Patients With Moderate Persistent Asthma.
ClinicalTrials.gov ID: NCT01233284
Acronym / sponsor ID: 205.380
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Nov 2010
Primary completion: Jan 2012 (actual)
First posted: 3 Nov 2010 (estimated)
Results: Posted 21 Jan 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: Crossover
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
tiotropium low dose once daily	Experimental	Drug: tiotropium bromide 1.25µg once dailyonce daily, delivered by the Respimat® inhaler
tiotropium medium dose once daily	Experimental	Drug: tiotropium bromide 2.5µg once dailyonce daily, delivered by the Respimat® inhaler
tiotropium high dose once daily	Experimental	Drug: tiotropium bromide high dose once dailyonce daily, delivered by the Respimat® inhaler
Placebo once daily	Placebo comparator	Drug: Tiotropium matching Placebo once dailyonce daily, delivered by the Respimat® inhaler

Who may qualify

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

Key inclusion criteria (12 listed)

All patients must sign and date an Informed Consent Form consistent with the Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) 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 between 18 and 75 years (at date of informed consent).
All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion no. 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 to 30 minutes after 4 puffs of 100 µg salbutamol) resulting in a Forced Expiratory Volume in one second (FEV1) increase of = 12% and = 200mL.

Key exclusion criteria (27 listed)

Patients with a significant disease other than asthma.
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 1.
Patients with a recent history (i.e. six months or less) of myocardial infarction.
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.

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 bromide 2.5µg once dailyEfficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo	Drug	tiotropium medium dose once daily
Tiotropium matching Placebo once dailyEfficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo	Drug	Placebo once daily
tiotropium bromide high dose once dailyEfficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo	Drug	tiotropium high dose once daily
tiotropium bromide 1.25µg once dailyIMP	Drug	tiotropium low dose once daily

Primary outcome

Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response
Time frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration
Mixed model repeated measurement (MMRM) results. Response was defined as change from baseline at the end of of each 4-week treatment period. Means are adjusted for treatment, period, patient and study baseline.

17 secondary outcomes

Trough FEV1 Response
Time frame: Baseline and 4 weeks
FEV1 Area Under the Curve 0-3 Hours (AUC0-3h) Response
Time frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration
Forced Vital Capacity (FVC) Peak Within 0-3 Hours Post-dose Response
Time frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration
Trough FVC Response
Time frame: Baseline and 4 weeks
FVC AUC0-3h Response
Time frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration
Individual FEV1 Over Time (at Each Timepoint at Visits) Response
Time frame: Baseline and 4 weeks
Individual FVC Over Time (at Each Timepoint at Visits) Response
Time frame: Baseline and 4 weeks
Individual Peak Expiratory Flow (PEF) Over Time (at Each Timepoint at Visits) Response
Time frame: Baseline and 4 weeks
Mean Pre-dose Morning PEF (PEF a.m.) Response During the Last Week on Treatment
Time frame: Baseline and 4 weeks
Mean Pre-dose Evening PEF (PEF p.m.) Response During the Last Week on Treatment
Time frame: Baseline and 4 weeks
PEF Variability Response (Last Week on Treatment)
Time frame: Baseline and 4 weeks
Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)
Time frame: Baseline and 4 weeks
Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)
Time frame: Baseline and 4 weeks
Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)
Time frame: Baseline and 4 weeks
Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)
Time frame: Baseline and 4 weeks
FEV1 Area Under the Curve Within 24 Hours (h) Response (FEV1 AUC0-12h, FEV1 AUC12-24h, FEV1 AUC0-24h)
Time frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration
FVC Area Under the Curve Within 24 Hours (h) Response (FVC AUC0-12h, FVC AUC12-24h, FVC AUC0-24h)
Time frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h, 4h, 11h 50min, 12h 30min, 13h, 14h, 15h, 16h, 18h, 20h, 22h, 23h, 23h 50min after drug administration

Results and safety

Results posted to the registry on 21 Jan 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
Tio R5 Once Daily(qd)/Tio R1.25 qd/Placebo/Tio R2.5 qd	37	36
Tio R2.5 qd/Placebo/Tio R1.25 qd/Tio R5 qd	38	37
Tio R1.25 qd/Tio R2.5 qd/Tio R5 qd/Placebo	38	37
Placebo/Tio R5 qd/Tio R2.5 qd/Tio R1.25 qd	35	35
Placebo/Tio R2.5 qd/Tio R5 qd/Tio R1.25 qd	1	1

Primary outcome: Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response

Time frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration. Mean (Standard Error). Unit: Litre

Measure	Placebo n = 144	Tio R1.25 qd n = 144	Tio R2.5 qd n = 144	Tio R5 qd n = 143
Value	0.116 (0.027)	0.255 (0.027)	0.244 (0.027)	0.304 (0.028)

Placebo vs Tio R1.25 qd: Mean Difference (Final Values): 0.138 (95% CI 0.090 to 0.186), p <0.0001, Mixed Models Analysis
Placebo vs Tio R2.5 qd: Mean Difference (Final Values): 0.128 (95% CI 0.080 to 0.176), p <0.0001, Mixed Models Analysis
Placebo vs Tio R5 qd: Mean Difference (Final Values): 0.188 (95% CI 0.140 to 0.236), p <0.0001, Mixed Models Analysis

Population analysed: Full analysis set (FAS) reduced to patients with non-missing FEV1 data. The FAS is defined as patients randomised, treated, with baseline data and at least one on-treatment efficacy measurement after 4 weeks on treatment within a period.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks + 30 days if in last period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 144 (0%)	0 of 144 (0%)	Not reported
Tio R1.25 qd	0 of 146 (0%)	0 of 146 (0%)	Not reported
Tio R2.5 qd	0 of 147 (0%)	0 of 147 (0%)	Not reported
Tio R5 qd	2 of 146 (1.4%)	0 of 146 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24890738Beeh KM, Moroni-Zentgraf P, Ablinger O, Hollaenderova Z, Unseld A, Engel M, Korn S. Tiotropium Respimat(R) in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma. Respir Res. 2014 Jun 3;15(1):61. doi: 10.1186/1465-9921-15-61.
Related InfoLink provided by the sponsor.
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

19 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 27 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Germany, Austria, Ukraine. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Jan 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?

Forced Expiratory Volume in One Second (FEV1) Peak Within 0-3 Hours Post-dose Response (time frame: 10 minutes (min) before drug administration and 30 min, 1h, 2h, 3h after drug administration). 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 NCT01233284, which also lists 1 linked publication.

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 24 Dec 2013; AzTrials last refreshed its copy on 1 Nov 2026.