AsthmaPhase 2NCT01152450
A Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Once Daily and Tiotropium 2.5 µg Twice Daily for Four Weeks in Patients With Moderate Persistent Asthma
A Phase 2 study testing Tiotropium 2.5 µg b.i.d and Tiotropium 5 µg q.d. in people with Asthma, run by Boehringer Ingelheim at 15 sites in 5 countries.
Trial summary
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. 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 µg b.i.d and Tiotropium 5 µg q.d.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Jul 2010to Aug 2011
- 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 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 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 at least 18 years but not more than 75 years.
- All patients must have at least a 3 months history of asthma at the time of enrolment into the trial. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility resulting in a Forced Expiratory Volume in 1 Second (FEV1) increase of equal above 12% and equal above 200mL.
- The initial diagnosis of asthma must have been made before the patient's age of 40.
- All patients must have a diagnosis of moderate persistent asthma and must be symptomatic despite their current maintenance treatment with medium doses of inhaled corticosteroids.
- 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 Betaadrenergic (LABA) or Short Acting Betaadrenergic (SABA)) for at least 4 weeks prior to Visit 1.
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- All patients must be symptomatic at Visit 1 (screening) and Visit 2 as defined by an Asthma Control Questionnaire (ACQ) Score
- All patients must have a pre-bronchodilator FEV1 above equal 60% predicted and below equal 90% of predicted normal at Visit 1. Predicted normal values will be calculated according to the European Coal and Steel Community Guidelines (ECSC).
- All patients must have an increase in FEV1 of equal above 12% and equal above 200 mL 15 minutes after 400 µg salbutamol at Visit 1.
- 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 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 the e-Diary/peak flow meter.
- 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) 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 hematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no. 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 (e.g. Chronic Obstructive Lung Disease (COPD)).
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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 with treated basal cell carcinoma are allowed.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients with significant alcohol or drug abuse 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 V 1.
- Patients with known hypersensitivity to anticholinergic drugs, Benzalconiumchloride (BAC), Ethylenediaminetetraacetate (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 been treated with beta-blocker medication within four weeks prior to Visit 1 or during the screening period. 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 or during the screening period.
- Patients who have been treated with oral beta-adrenergics within four weeks prior to Visit 1 or during the screening period.
- Patients who have been treated with oral corticosteroids within four weeks prior to Visit 1 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 or during the screening period.20. Patients who have been treated with cromolyn sodium or nedocromil sodium within two weeks prior to Visit 1 or during the screening period.
- 21. Patients who have been treated with methylxanthines within two weeks prior to Visit 1 or during the screening period.
- 22. Patients who have taken an investigational drug within four weeks prior to Visit 1.
- 23. 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 or during the screening period.
- 24. Patients with any asthma exacerbation or any respiratory tract infection in the four weeks prior to Visit 1 or during the screening period. Visit 1 and/or Visit 2 should be postponed in case of an asthma exacerbation or respiratory tract infection.
- 25. Patients who have previously been randomised in this trial or are currently participating in another trial.
- 26.Patients who have been treated with depot corticosteroids within six months prior to Visit 1 or during the screening period.
- 27.Patients who have been treated with leukotriene modifiers within two weeks prior to Visit 1 or during the screening period.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Austria4 sites
205.420.43002 Boehringer Ingelheim Investigational Site
Linz
205.420.43004 Boehringer Ingelheim Investigational Site
Schlüsslberg
205.420.43003 Boehringer Ingelheim Investigational Site
Thalheim bei Wels
205.420.43001 Boehringer Ingelheim Investigational Site
Wels
Germany4 sites
205.420.49002 Boehringer Ingelheim Investigational Site
Großhansdorf
205.420.49004 Boehringer Ingelheim Investigational Site
Hanover
205.420.49001 Boehringer Ingelheim Investigational Site
Mannheim
205.420.49003 Boehringer Ingelheim Investigational Site
Schwerin
Latvia3 sites
205.420.37102 Boehringer Ingelheim Investigational Site
Daugavpils
205.420.37101 Boehringer Ingelheim Investigational Site
Riga
205.420.37103 Boehringer Ingelheim Investigational Site
Riga
Czechia2 sites
205.420.42002 Boehringer Ingelheim Investigational Site
Brno
205.420.42001 Boehringer Ingelheim Investigational Site
Kyjov
Estonia2 sites
205.420.37201 Boehringer Ingelheim Investigational Site
Kohtla-Järve
205.420.37202 Boehringer Ingelheim Investigational Site
Tallinn
About this study
Official title: A Phase II, Randomised, Double- Blind, Placebo Controlled, Cross-over Efficacy and Safety Comparison of Tiotropium 5 µg Administered Once Daily (in the Evening) and Tiotropium 2.5 µg Administered Twice Daily Delivered by the Respimat® Inhaler for Four Weeks Versus Placebo in Patients With Moderate Persistent Asthma
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.
Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.
- Conditions
- Asthma
- Being tested
- Tiotropium 2.5 µg b.i.d, Placebo, Tiotropium 5 µg q.d.
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium 2.5 µg b.i.dDrug
2.5 µg (two actuations of 1.25 µg) delivered via Respimat® inhaler
PlaceboDrug
N/A (two actuations of placebo) delivered via Respimat® inhaler
Tiotropium 5 µg q.d.Drug
5 µg (two actuations of 2.5 µg) delivered via Respimat® inhaler
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium daily dose q.d. | Experimental | two actuations delivered via Respimat® inhaler Receives: Drug: Tiotropium 5 µg q.d. |
| Tiotropium half daily dose b.i.d. | Experimental | two actuations delivered via Respimat® inhaler Receives: Drug: Tiotropium 2.5 µg b.i.d |
| Placebo | Placebo comparator | N/A (two actuations of placebo) delivered via Respimat® inhaler Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response
Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measurements performed in relation to evening dosing. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.
Measured: 10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
Secondary outcomes (20)
Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on Treatment
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.
Measured: Baseline and during week 4 of each treatment period
Mean Pre-dose Evening Peak Expiratory Flow (PEF p.m.) Response During the Last Week on Treatment
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured by patients at home using the AM2+ device.
Measured: Baseline and during week 4 of each treatment period
FEV1 Area Under the Curve 0-12 Hours (AUC0-12h) Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.
Measured: 10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4
FEV1 Area Under the Curve 12-24 Hours (AUC12-24h) Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the respective dosing determined at the end of each 4 week period of randomised treatment. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.
Measured: 10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
Peak FEV1 Within 24 Hours Post-dose Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following the evening trial-drug inhalation at the end of each 4 week period of randomised treatment.
Measured: Baseline and 4 weeks
Trough FEV1 Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FEV1 is defined as FEV1 value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.
Measured: Baseline and 4 weeks
Trough Forced Vital Capacity (FVC) Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Trough FVC is defined as FVC value (performed at 10 minutes prior to the evening trial-drug inhalation) at the end of each 4 week period of randomised treatment.
Measured: Baseline and 4 weeks
FVC Area Under the Curve 0-12 Hours (AUC0-12h) Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC0-12h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.
Measured: 10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4
FVC Area Under the Curve 12-24 Hours (AUC12-24h) Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period. AUC12-24h calculated using the trapezoidal rule divided by the observation time (12 hours) to report in litres.
Measured: 10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
Peak FVC Within 24 Hours Post-dose Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measured following each dosing determined at the end of each 4 week treatment period.
Measured: Baseline and 4 weeks
Individual FEV1 Over Time (at Each Timepoint at Visits) Response
MMRM results. Response was defined as change from baseline. 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. 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. Means are adjusted for treatment, period, patient and study baseline.
Measured: Baseline and 4 weeks
FVC Area Under the Curve 0-24 Hours (AUC0-24h) Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.
Measured: 10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
PEF Area Under the Curve 0-24 Hours (AUC0-24h) Response
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres/min.
Measured: 10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
PEF Variability Response (Last Week on Treatment)
MMRM results. Response was defined as change from baseline. 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 during week 4
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. 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: Baseline and during week 4
Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)
MMRM results. Response was defined as change from baseline. 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: Baseline and during week 4
Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)
MMRM results. Response was defined as change from baseline. 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: Baseline and during week 4
Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)
MMRM results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Assessed by the patient's electronic diary (eDiary incorporated in the AM2+ device), obtained during the last week of each period of randomised treatment.
Measured: Baseline and during week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2011
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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152450
- Sponsor's protocol ID
- 205.420
- Other IDs
- 2009-018006-21, 2009
- Status last verified
- Dec 2024
- First submitted
- 28 Jun 2010
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Timmer W, Moroni-Zentgraf P, Cornelissen P, Unseld A, Pizzichini E, Buhl R. Once-daily tiotropium Respimat((R)) 5 mug is an efficacious 24-h bronchodilator in adults with symptomatic asthma. Respir Med. 2015 Mar;109(3):329-38. doi: 10.1016/j.rmed.2014.12.005. Epub 2014 Dec 27.
PubMed 25661281
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. 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 Tiotropium 5 µg Administered Once Daily (in the Evening) and Tiotropium 2.5 µg Administered Twice Daily Delivered by the Respimat® Inhaler for Four Weeks Versus Placebo in Patients With Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT01152450
- Acronym / sponsor ID
- 205.420
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2010
- Primary completion
- Aug 2011 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Posted 30 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma.
Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium daily dose q.d. | Experimental | Drug: Tiotropium 5 µg q.d.two actuations delivered via Respimat® inhaler |
| Tiotropium half daily dose b.i.d. | Experimental | Drug: Tiotropium 2.5 µg b.i.dtwo actuations delivered via Respimat® inhaler |
| Placebo | Placebo comparator | Drug: PlaceboN/A (two actuations of placebo) 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 (14 listed)
- All patients must sign and date an Informed Consent Form consistent with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use 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 at least 18 years but not more than 75 years.
- All patients must have at least a 3 months history of asthma at the time of enrolment into the trial. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility resulting in a Forced Expiratory Volume in 1 Second (FEV1) increase of equal above 12% and equal above 200mL.
- The initial diagnosis of asthma must have been made before the patient's age of 40.
- All patients must have a diagnosis of moderate persistent asthma and must be symptomatic despite their current maintenance treatment with medium doses of inhaled corticosteroids.
Key exclusion criteria (26 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 hematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion no. 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 2.5 µg b.i.d2.5 µg (two actuations of 1.25 µg) delivered via Respimat® inhaler | Drug | Tiotropium half daily dose b.i.d. |
| PlaceboN/A (two actuations of placebo) delivered via Respimat® inhaler | Drug | Placebo |
| Tiotropium 5 µg q.d.5 µg (two actuations of 2.5 µg) delivered via Respimat® inhaler | Drug | Tiotropium daily dose q.d. |
Primary outcome
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve 0-24 Hours (AUC0-24h) Response
Time frame: 10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
Mixed Model Repeated Measure (MMRM) results. Response was defined as change from baseline. Means are adjusted for treatment, period, patient and study baseline. Measurements performed in relation to evening dosing. AUC0-24h calculated using the trapezoidal rule divided by the observation time (24 hours) to report in litres.
20 secondary outcomes
Mean Pre-dose Morning Peak Expiratory Flow (PEF a.m.) Response During the Last Week on Treatment
Time frame: Baseline and during week 4 of each treatment period
Mean Pre-dose Evening Peak Expiratory Flow (PEF p.m.) Response During the Last Week on Treatment
Time frame: Baseline and during week 4 of each treatment period
FEV1 Area Under the Curve 0-12 Hours (AUC0-12h) Response
Time frame: 10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4
FEV1 Area Under the Curve 12-24 Hours (AUC12-24h) Response
Time frame: 10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
Peak FEV1 Within 24 Hours Post-dose Response
Time frame: Baseline and 4 weeks
Trough FEV1 Response
Time frame: Baseline and 4 weeks
Trough Forced Vital Capacity (FVC) Response
Time frame: Baseline and 4 weeks
FVC Area Under the Curve 0-12 Hours (AUC0-12h) Response
Time frame: 10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h and 11 h 50 min related to evening dose at week 4
FVC Area Under the Curve 12-24 Hours (AUC12-24h) Response
Time frame: 10 min prior to first dose (baseline) and 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
Peak FVC Within 24 Hours Post-dose Response
Time frame: Baseline and 4 weeks
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
FVC Area Under the Curve 0-24 Hours (AUC0-24h) Response
Time frame: 10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
PEF Area Under the Curve 0-24 Hours (AUC0-24h) Response
Time frame: 10 min prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 h, 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4
PEF Variability Response (Last Week on Treatment)
Time frame: Baseline and during week 4
Mean Number of Puffs of Rescue Medication During the Whole Day (Last Week on Treatment, Response Values)
Time frame: Baseline and during week 4
Mean Number of Puffs of Rescue Medication During Daytime (Last Week on Treatment, Response Values)
Time frame: Baseline and during week 4
Mean Number of Puffs of Rescue Medication During Nighttime (Last Week on Treatment, Response Values)
Time frame: Baseline and during week 4
Mean Number of Night Awakenings During the Last Week on Treatment (Score, Response Values)
Time frame: Baseline and during week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25661281Timmer W, Moroni-Zentgraf P, Cornelissen P, Unseld A, Pizzichini E, Buhl R. Once-daily tiotropium Respimat((R)) 5 mug is an efficacious 24-h bronchodilator in adults with symptomatic asthma. Respir Med. 2015 Mar;109(3):329-38. doi: 10.1016/j.rmed.2014.12.005. Epub 2014 Dec 27.
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Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
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
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiotropium 2.5 µg b.i.d and Tiotropium 5 µg q.d. in people with Asthma, run by Boehringer Ingelheim at 15 sites in 5 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 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Austria, Germany, Latvia, Czechia, Estonia. 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 30 Oct 2012). 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) Area Under the Curve 0-24 Hours (AUC0-24h) Response (time frame: 10 minutes (min) prior to first dose (baseline) and -10 min, 30 min, 60 min, 2 hours (h) , 3 h, 4 h , 11 h 50 min, 12 h 30 min, 13 h, 14 h, 15 h, 16 h, 18 h, 20 h, 22 h, 23 h, and 23 h 50 min related to evening dose at week 4). 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 NCT01152450, 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 19 Dec 2024.