AsthmaPhase 3NCT01257230
Efficacy and Safety of 2 Doses of Tiotropium Via Respimat Compared to Placebo in Adolescents With Moderate Persistent Asthma
A Phase 3 study testing tiotropium Respimat low dose and tiotropium Respimat high dose in people with Asthma, run by Boehringer Ingelheim at 66 sites in 12 countries.
Trial summary
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- tiotropium Respimat low dose and tiotropium Respimat high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 398 participants
- Where
- 66 sitesin 12 countries
- Study dates
- Dec 2010to Dec 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients and their parents (or legally accepted caregiver) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial.
- Male or female patients between 12 and 17 years of age.
- 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 test.
- All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose for at least 4 weeks before Visit 1.
- All patients must be symptomatic (partly controlled) at Visit 1 (screening) and at randomisation defined by an Asthma Control Questionnaire (ACQ) mean score of more than or equal to 1.5.
- All patients must have a pre-bronchodilator FEV1 more than or equal to 60% and less than or equal to 90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 1 as compared to Visit 2 must be within ± 30%.
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- All patients must have an increase in FEV1 of equal or above 12% and 200 mL after 400 µg salbutamol (albuterol) at Visit 1. If patients in the lower age range (e.g., 12 to 14 year olds) exhibit a very small total lung volume, positive reversibility testing might be based solely on the relative (12%) post-bronchodilator response.
- All patients should be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.
- Patients should be able to use the Respimat® inhaler correctly.
- Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres.
Who cannot join
- Patients with a significant disease other than asthma.
- Patients with clinically relevant abnormal screening haematology or blood chemistry
- Patients with a history of congenital or acquired heart disease, and/or have been hospitalised for cardiac syncope or 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 malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
- Patients with lung diseases other than asthma (e.g. Cystic Fibrosis). In case of ex-premature infants, a history of significant bronchopulmonary dysplasia will be regarded as exclusion criterion.
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- Patients with known active tuberculosis.
- Patients with significant alcohol or drug abuse within the past two years.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
- Patients with known hypersensitivity to anticholinergic drugs, Benzalkonium chloride (BAC), Ethylenediaminetetraacetic acis (EDTA) or any other components of the tiotropium inhalation solution.
- Pregnant or nursing adolescent female patients
- Sexually active female patients of child-bearing potential not using a highly effective method of birth control.
- Patients who have taken an investigational drug within 4 weeks prior to Visit 1.
- Patients who have been treated with long-acting anticholinergics (e.g. tiotropium -Spiriva) within four weeks prior to screening (Visit 1).
- Patients who are unable to comply with pulmonary medication restrictions prior to randomisation.
- Patients who have been treated with Anti-IgE treatment (Omalizumab Xolair) within the last 6 months prior to screening.
- Patients who have been treated with systemic (oral or intravenous) corticosteroids within 4 weeks prior to screening (Visit 1).
- Patients who have been treated with long-acting theophylline preparations within 2 weeks prior to screening (Visit 1) or during the run-in period
- Patients who have been treated with other non-approved and according to international guidelines not recommended ¿experimental¿ drugs for routine asthma therapy.
- Patients with any acute asthma exacerbation or respiratory tract infection in the 4 weeks prior to Visit 1.
- Patients requiring 10 or more puffs of rescue medication (salbutamol/albuterol) per day on more than 2 consecutive days during the run-in period.
- Patients who have previously been randomised in this trial or are currently participating in another study.
- Patients who are being treated with oral beta-blocker medication.
- Patients with a known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
- Patients with renal impairment, as defined by a creatinine clearance less than 50 mL/min/1.73 m2 Body Surface Area as calculated by Schwartz formula.
Trial locations and contacts
66 sites in 12 countries.
66 sites in 12 countries
United States8 sites
205.444.01002 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.444.01012 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.444.01001 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.444.01005 Boehringer Ingelheim Investigational Site
Columbia, Missouri
205.444.01013 Boehringer Ingelheim Investigational Site
El Paso, Texas
205.444.01014 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
205.444.01004 Boehringer Ingelheim Investigational Site
Plymouth, Minnesota
205.444.01003 Boehringer Ingelheim Investigational Site
South Burlington, Vermont
Hungary8 sites
205.444.36007 Boehringer Ingelheim Investigational Site
Ajka
205.444.36005 Boehringer Ingelheim Investigational Site
Budapest
205.444.36008 Boehringer Ingelheim Investigational Site
Budapest
205.444.36006 Boehringer Ingelheim Investigational Site
Kaposvár
205.444.36001 Boehringer Ingelheim Investigational Site
Miskolc
205.444.36002 Boehringer Ingelheim Investigational Site
Mosdós
205.444.36003 Boehringer Ingelheim Investigational Site
Szeged
205.444.36004 Boehringer Ingelheim Investigational Site
Szigetbecse
Ukraine8 sites
205.444.38008 Boehringer Ingelheim Investigational Site
Dnipropetrovsk
205.444.38002 Boehringer Ingelheim Investigational Site
Donetsk
205.444.38005 Boehringer Ingelheim Investigational Site
Kharkiv
205.444.38003 Boehringer Ingelheim Investigational Site
Kiev
205.444.38004 Boehringer Ingelheim Investigational Site
Kiev
205.444.38001 Boehringer Ingelheim Investigational Site
Lviv
205.444.38010 Boehringer Ingelheim Investigational Site
Zaporizhya
205.444.38009 Boehringer Ingelheim Investigational Site
Zaporizhzhya
Latvia7 sites
205.444.37101 Boehringer Ingelheim Investigational Site
Baldone
205.444.37107 Boehringer Ingelheim Investigational Site
Balvi
205.444.37102 Boehringer Ingelheim Investigational Site
Ogre
205.444.37105 Boehringer Ingelheim Investigational Site
Rēzekne
205.444.37106 Boehringer Ingelheim Investigational Site
Riga
205.444.37103 Boehringer Ingelheim Investigational Site
Talsi
205.444.37104 Boehringer Ingelheim Investigational Site
Tukums
Germany6 sites
205.444.49007 Boehringer Ingelheim Investigational Site
Berlin
205.444.49008 Boehringer Ingelheim Investigational Site
Berlin
205.444.49001 Boehringer Ingelheim Investigational Site
Bochum
205.444.49003 Boehringer Ingelheim Investigational Site
Ettenheim
205.444.49006 Boehringer Ingelheim Investigational Site
Koblenz
205.444.49005 Boehringer Ingelheim Investigational Site
Rosenheim
Russia6 sites
205.444.70003 Boehringer Ingelheim Investigational Site
Moscow
205.444.70002 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.444.70004 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.444.70005 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.444.70006 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.444.70001 Boehringer Ingelheim Investigational Site
Yaroslavl
Spain6 sites
205.444.34007 Boehringer Ingelheim Investigational Site
Esplugues Del Llobregat
205.444.34001 Boehringer Ingelheim Investigational Site
Madrid
205.444.34004 Boehringer Ingelheim Investigational Site
Majadahonda (Madrid)
205.444.34005 Boehringer Ingelheim Investigational Site
Marbella
205.444.34006 Boehringer Ingelheim Investigational Site
Sabdadell
205.444.34008 Boehringer Ingelheim Investigational Site
Valencia
Slovakia4 sites
205.444.42104 Boehringer Ingelheim Investigational Site
Košice
205.444.42106 Boehringer Ingelheim Investigational Site
Martin
205.444.42101 Boehringer Ingelheim Investigational Site
Nitra
205.444.42105 Boehringer Ingelheim Investigational Site
Rožňava
South Korea4 sites
205.444.82003 Boehringer Ingelheim Investigational Site
Guri-si
205.444.82006 Boehringer Ingelheim Investigational Site
Incheon
205.444.82001 Boehringer Ingelheim Investigational Site
Seoul
205.444.82004 Boehringer Ingelheim Investigational Site
Seoul
Chile3 sites
205.444.56002 Boehringer Ingelheim Investigational Site
Santiago
205.444.56001 Boehringer Ingelheim Investigational Site
Viña del Mar
205.444.56003 Boehringer Ingelheim Investigational Site
Viña del Mar
Italy3 sites
205.444.39001 Boehringer Ingelheim Investigational Site
Ancona
205.444.39003 Boehringer Ingelheim Investigational Site
Bolzano
205.444.39002 Boehringer Ingelheim Investigational Site
Verona
Mexico3 sites
205.444.52002 Boehringer Ingelheim Investigational Site
Guadalajara
205.444.52001 Boehringer Ingelheim Investigational Site
Hermosillo
205.444.52003 Boehringer Ingelheim Investigational Site
Monterrey
About this study
Official title: A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 and 5 µg Once Daily ) Delivered by the Respimat® Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma.
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.
- Conditions
- Asthma
- Being tested
- tiotropium Respimat low dose, placebo Respimat, tiotropium Respimat high dose
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropium Respimat low doseDrug
IMP
placebo RespimatDrug
placebo representing comparator
tiotropium Respimat high doseDrug
IMP
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | once daily, delivered with Respimat inhaler Receives: Drug: placebo Respimat |
| tiotropium low dose | Experimental | once daily, delivered with Respimat inhaler Receives: Drug: tiotropium Respimat low dose |
| tiotropium high dose | Experimental | once daily, delivered with Respimat inhaler Receives: Drug: tiotropium Respimat high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 peak0-3 Change From Baseline
Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24.
Note, the measured values presented are actually adjusted means.
Measured: Baseline and 24 weeks
Secondary outcomes (15)
Trough FEV1 Change From Baseline
Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 24.
The measured values presented are actually adjusted means.
Measured: Baseline and 24 weeks
FVC peak0-3 Change From Baseline
Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 h after administration of trial medication (FVC peak0-3h) after 24 weeks of treatment.
The measured values presented are actually adjusted means.
Measured: Baseline and 24 weeks
Trough FVC Change From Baseline
Change from baseline of Trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 24 weeks of treatment.
The measured values presented are actually adjusted means..
Measured: Baseline and 24 weeks
FEV1 AUC (0-3h) Change From Baseline
Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0-3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
The measured values presented are actually adjusted means.
Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks
FVC AUC (0-3h) Change From Baseline
Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0-3h) after 24 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
The measured values presented are actually adjusted means.
Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks
FEF25-75 Change From Baseline
Change from baseline in mean forced expiratory flow between 25% and 75% of the FVC (FEF25-75%), also known as maximum mid-expiratory flow, at individual time points after 24 weeks of treatment.
The measured values presented are actually adjusted means.
Measured: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks
Use of PRN Rescue Medication During the Daytime
Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the daytime based on the weekly mean at week 24.
The measured values presented are actually adjusted means.
Measured: Baseline and Week 24
Use of PRN Rescue Medication During the Night-time
Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the night-time based on the weekly mean at week 24.
The measured values presented are actually adjusted means.
Measured: Baseline and week 24
Use of PRN Rescue Medication During the Day
Change from baseline in the number of puffs of rescue medication (salbutamol/albuterol) used during the day (24 hour period) based on the weekly mean at week 24.
The measured values presented are actually adjusted means.
Measured: Baseline and week 24
Control of Asthma as Assessed by ACQ Total Score
Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 24.
The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment. ACQ total score was calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means.
Measured: Baseline and week 24
ACQ Total Score Responders
Responder rates based on the ACQ total score after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)
The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.
Measured: Week 24
Control of Asthma as Assessed by ACQ6
Change from baseline in AQC6 score at week 24.
The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.
The measured values presented are actually adjusted means.
Measured: Baseline and week 24
ACQ6 Responders
Responder rates based on the ACQ6 after 24 weeks of treatment. Analysis was performed using the following categories and definitions: responder (change from trial baseline ≤-0.5), no change (-0.5 <change from trial baseline <0.5) and worsening (change from trial baseline ≥0.5)
The ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ. The ACQ is a scale containing 7 questions, each question has a 7-point scale which ranges from 0 to 6; a score of 0 corresponds to no impairment and a score of 6 corresponds to maximum impairment.
Measured: Week 24
Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period
The median time to first severe asthma exacerbation was not calculable, so the number of patients who experienced a severe asthma exacerbation are presented for the measured values. A severe asthma exacerbation was defined as a subgroup of all asthma exacerbations that required treatment with systemic corticosteroid for at least 3 days.
Measured: 48 weeks
Time to First Asthma Exacerbation During the 48 Week Treatment Period
The median time to first asthma exacerbation was not calculable, so the number of patients who experienced an asthma exacerbation are presented for the measured values.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (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
- 398 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
- NCT01257230
- Sponsor's protocol ID
- 205.444
- Other IDs
- 2010-021093-11
- Status last verified
- Aug 2014
- First submitted
- 6 Dec 2010
- Last updated
- 5 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
PubMed 36472162Halpin 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 32180164Halpin 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 31319851Hamelmann E, Bateman ED, Vogelberg C, Szefler SJ, Vandewalker M, Moroni-Zentgraf P, Avis M, Unseld A, Engel M, Boner AL. Tiotropium add-on therapy in adolescents with moderate asthma: A 1-year randomized controlled trial. J Allergy Clin Immunol. 2016 Aug;138(2):441-450.e8. doi: 10.1016/j.jaci.2016.01.011. Epub 2016 Mar 5.
PubMed 26960245
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 and 5 µg Once Daily ) Delivered by the Respimat® Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma.
- ClinicalTrials.gov ID
- NCT01257230
- Acronym / sponsor ID
- 205.444
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 8 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring lung function parameters and evaluating the effects on asthma exacerbations, on Quality of life, on health care resource utilisation an on the number of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo Respimatonce daily, delivered with Respimat inhaler |
| tiotropium low dose | Experimental | Drug: tiotropium Respimat low doseonce daily, delivered with Respimat inhaler |
| tiotropium high dose | Experimental | Drug: tiotropium Respimat high doseonce daily, delivered with Respimat inhaler |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- All patients and their parents (or legally accepted caregiver) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial.
- Male or female patients between 12 and 17 years of age.
- 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 test.
- All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose for at least 4 weeks before Visit 1.
- All patients must be symptomatic (partly controlled) at Visit 1 (screening) and at randomisation defined by an Asthma Control Questionnaire (ACQ) mean score of more than or equal to 1.5.
Key exclusion criteria (26 listed)
- Patients with a significant disease other than asthma.
- Patients with clinically relevant abnormal screening haematology or blood chemistry
- Patients with a history of congenital or acquired heart disease, and/or have been hospitalised for cardiac syncope or 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 malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.
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 Respimat low doseIMP | Drug | tiotropium low dose |
| placebo Respimatplacebo representing comparator | Drug | placebo |
| tiotropium Respimat high doseIMP | Drug | tiotropium high dose |
Primary outcome
FEV1 peak0-3 Change From Baseline
Time frame: Baseline and 24 weeks
Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak0-3) measured at week 24. Note, the measured values presented are actually adjusted means.
15 secondary outcomes
Trough FEV1 Change From Baseline
Time frame: Baseline and 24 weeks
FVC peak0-3 Change From Baseline
Time frame: Baseline and 24 weeks
Trough FVC Change From Baseline
Time frame: Baseline and 24 weeks
FEV1 AUC (0-3h) Change From Baseline
Time frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks
FVC AUC (0-3h) Change From Baseline
Time frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks
FEF25-75 Change From Baseline
Time frame: Baseline and 10 mins before drug administration and 30 mins, 1 hour (h), 2h, 3h after drug administration at 24 weeks
Use of PRN Rescue Medication During the Daytime
Time frame: Baseline and Week 24
Use of PRN Rescue Medication During the Night-time
Time frame: Baseline and week 24
Use of PRN Rescue Medication During the Day
Time frame: Baseline and week 24
Control of Asthma as Assessed by ACQ Total Score
Time frame: Baseline and week 24
ACQ Total Score Responders
Time frame: Week 24
Control of Asthma as Assessed by ACQ6
Time frame: Baseline and week 24
ACQ6 Responders
Time frame: Week 24
Time to First Severe Asthma Exacerbation During the 48 Week Treatment Period
Time frame: 48 weeks
Time to First Asthma Exacerbation During the 48 Week Treatment Period
Time frame: Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Derived from this study: PubMed 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 26960245Hamelmann E, Bateman ED, Vogelberg C, Szefler SJ, Vandewalker M, Moroni-Zentgraf P, Avis M, Unseld A, Engel M, Boner AL. Tiotropium add-on therapy in adolescents with moderate asthma: A 1-year randomized controlled trial. J Allergy Clin Immunol. 2016 Aug;138(2):441-450.e8. doi: 10.1016/j.jaci.2016.01.011. Epub 2016 Mar 5.
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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
66 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 Respimat low dose and tiotropium Respimat high dose in people with Asthma, run by Boehringer Ingelheim at 66 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 10 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Hungary, Ukraine, Latvia, Germany 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 8 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 peak0-3 Change From Baseline (time frame: Baseline and 24 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 NCT01257230, 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 5 Sep 2014.