AsthmaPhase 3NCT01277523
Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma
A Phase 3 study testing tiotropium high dose and tiotropium low dose in people with Asthma, run by Boehringer Ingelheim at 69 sites in 14 countries.
Trial summary
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe 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 high dose and tiotropium low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 392 participants
- Where
- 69 sitesin 14 countries
- Study dates
- Jan 2011to Oct 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 parent(s) (or legally accepted representative) must sign and date respectively an informed assent and an informed consent consistent with International Conference on Harmonisation - Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to the patient's participation in the trial. A separate informed consent/assent is required for pharmacogenomic sampling.
- Male or female patients between 12 and 17 years of age (at date of informed consent/assent).
- All patients must have at least a 3-month history of asthma at the time of enrolment into the trial.
- All patients must have been on maintenance treatment with an inhaled corticosteroid either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1.
- 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 Forced Expiratory Volume in 1 second (FEV1) = 60% and = 90% of predicted normal at Visit 1.
Show all 11Show fewer
- Variation of absolute FEV1 values of Visit 1 (pre-bronchodilator, considered as 100%) as compared to Visit 2 (pre-dose) must be within ± 30%.
- All patients must confirm the diagnosis of asthma by bronchodilator reversibility at Visit 1, resulting in an increase in FEV1 of = 12% and = 200 mL 15 to 30 minutes after 400 µg salbutamol (albuterol). If patients in the lower age range (e.g. 12 to 14 year old patients) exhibit a very small total lung volume, positive reversibility testing might be based solely on the relative (=12%) post-bronchodilator response.
- All patients must be never-smokers or ex-smokers who stopped smoking at least one year prior to enrolment.
- Patients must be able to use the Respimat® inhaler correctly.
- Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres according to American Thoracic Society/ European Respiratory Society (ATS/ERS) standards and use of the electronic diary/peak flow meter (diary compliance of at least 80% is required).
Who cannot join
- Significant disease other than asthma.
- Abnormal haematology or blood chemistry.
- History of heart disease, and/or hospitalised for cardiac syncope or failure.
- Any unstable or life-threatening or requiring intervention or cardiac arrhythmia.
- Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
- Active tuberculosis.
Show all 27Show fewer
- Alcohol or drug abuse.
- Thoracotomy with pulmonary resection.
- Pulmonary rehabilitation program.
- Hypersensitivity to anticholinergic drugs, or any components of the study medication delivery system.
- Pregnant or nursing adolescent female patients.
- Female patients of child-bearing potential not using a highly effective method of birth control.
- Investigational drug within four weeks or six half lives prior to Visit 1.
- Long-acting anticholinergics within four weeks prior to Visit 1.
- Systemic corticosteroids at a high dose or at a not stable low dose within four weeks prior to Visit 1.
- Leukotriene modifiers if not stabilised for at least four weeks prior to Visit 1.
- Long-acting theophylline preparations if not stabilised for at least two weeks prior to Visit 1.
- Anti Immunoglobulin E (Anti-IgE) treatment if not stabilised for at least six months prior to Visit 1.
- Cromones if not stabilised within four weeks prior to Visit 1.
- Oral beta-blocker medication within four weeks prior to Visit 1.
- Systemic oral or i.v. or s.c. beta-adrenergics within four weeks prior to Visit 1.
- Other non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1.
- Any acute asthma exacerbation or respiratory tract infection in the four weeks prior to Visit 1and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
- Randomised in this trial or currently participating in another trial.
- Narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
- Moderate to severe renal impairment.
- Patients requiring 10 or more puffs of rescue medication per day on more than 2 consecutive days in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2. In case of an asthma deterioration occurring in the four weeks prior to Visit 1 and/or in the four weeks prior to Visit 2, the visit must be postponed.
Trial locations and contacts
69 sites in 14 countries.
69 sites in 14 countries
Ukraine10 sites
205.456.38006 Boehringer Ingelheim Investigational Site
Dnipropetrovsk
205.456.38004 Boehringer Ingelheim Investigational Site
Kharkiv
205.456.38003 Boehringer Ingelheim Investigational Site
Kiev
205.456.38010 Boehringer Ingelheim Investigational Site
Kryvyi Rih
205.456.38009 Boehringer Ingelheim Investigational Site
Kyiv
205.456.38001 Boehringer Ingelheim Investigational Site
Lviv
205.456.38007 Boehringer Ingelheim Investigational Site
Lviv
205.456.38005 Boehringer Ingelheim Investigational Site
Uzhhorod
205.456.38008 Boehringer Ingelheim Investigational Site
Vinnytsia
205.456.38002 Boehringer Ingelheim Investigational Site
Zaporizhzhya
United States8 sites
205.456.01003 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
205.456.01002 Boehringer Ingelheim Investigational Site
Bellevue, Nebraska
205.456.01005 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
205.456.01007 Boehringer Ingelheim Investigational Site
Columbia, Missouri
205.456.01008 Boehringer Ingelheim Investigational Site
Normal, Illinois
205.456.01001 Boehringer Ingelheim Investigational Site
Rockville Centre, New York
205.456.01004 Boehringer Ingelheim Investigational Site
Stockton, California
205.456.01006 Boehringer Ingelheim Investigational Site
Summerville, South Carolina
Germany8 sites
205.456.49008 Boehringer Ingelheim Investigational Site
Berlin
205.456.49001 Boehringer Ingelheim Investigational Site
Bochum
205.456.49004 Boehringer Ingelheim Investigational Site
Frankfurt
205.456.49005 Boehringer Ingelheim Investigational Site
Kehl
205.456.49003 Boehringer Ingelheim Investigational Site
Koblenz
205.456.49010 Boehringer Ingelheim Investigational Site
Mainz
205.456.49007 Boehringer Ingelheim Investigational Site
Neu-Isenburg
205.456.49002 Boehringer Ingelheim Investigational Site
Wesel
Argentina7 sites
205.456.54002 Boehringer Ingelheim Investigational Site
Capital Federal
205.456.54006 Boehringer Ingelheim Investigational Site
Capital Federal
205.456.54008 Boehringer Ingelheim Investigational Site
Capital Federal
205.456.54005 Boehringer Ingelheim Investigational Site
Mendoza
205.456.54003 Boehringer Ingelheim Investigational Site
San Juan Bautista
205.456.54004 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán
205.456.54009 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán
Hungary6 sites
205.456.36005 Boehringer Ingelheim Investigational Site
Budapest
205.456.36002 Boehringer Ingelheim Investigational Site
Debrecen
205.456.36004 Boehringer Ingelheim Investigational Site
Gyula
205.456.36001 Boehringer Ingelheim Investigational Site
Miskolc
205.456.36007 Boehringer Ingelheim Investigational Site
Mosdós
205.456.36006 Boehringer Ingelheim Investigational Site
Nagyatád
Latvia5 sites
205.456.37101 Boehringer Ingelheim Investigational Site
Baldone
205.456.37104 Boehringer Ingelheim Investigational Site
Balvi
205.456.37103 Boehringer Ingelheim Investigational Site
Rēzekne
205.456.37102 Boehringer Ingelheim Investigational Site
Riga
205.456.37105 Boehringer Ingelheim Investigational Site
Talsi
Portugal5 sites
205.456.35105 Boehringer Ingelheim Investigational Site
Coimbra
205.456.35101 Boehringer Ingelheim Investigational Site
Lisbon
205.456.35102 Boehringer Ingelheim Investigational Site
Lisbon
205.456.35104 Boehringer Ingelheim Investigational Site
Lisbon
205.456.35103 Boehringer Ingelheim Investigational Site
Porto
Guatemala4 sites
205.456.50201 Boehringer Ingelheim Investigational Site
Guatemala City
205.456.50203 Boehringer Ingelheim Investigational Site
Guatemala City
205.456.50204 Boehringer Ingelheim Investigational Site
Guatemala City
205.456.50205 Boehringer Ingelheim Investigational Site
Guatemala City
Mexico4 sites
205.456.52001 Boehringer Ingelheim Investigational Site
Hermosillo Sonora
205.456.52002 Boehringer Ingelheim Investigational Site
Monterrey
205.456.52003 Boehringer Ingelheim Investigational Site
Monterrey
205.456.52004 Boehringer Ingelheim Investigational Site
Nuevo León
Bulgaria3 sites
205.456.35902 Boehringer Ingelheim Investigational Site
Plovdiv
205.456.35901 Boehringer Ingelheim Investigational Site
Rousse
205.456.35903 Boehringer Ingelheim Investigational Site
Sofia
Israel3 sites
205.456.97205 Boehringer Ingelheim Investigational Site
Holon
205.456.97203 Boehringer Ingelheim Investigational Site
Petah Tikva
205.456.97201 Boehringer Ingelheim Investigational Site
Safed
Australia2 sites
205.456.61002 Boehringer Ingelheim Investigational Site
Parkville, Victoria
205.456.61001 Boehringer Ingelheim Investigational Site
Perth, Western Australia
Philippines2 sites
205.456.09001 Boehringer Ingelheim Investigational Site
Quezon City
205.456.09002 Boehringer Ingelheim Investigational Site
Quezon City
South Africa2 sites
205.456.27001 Boehringer Ingelheim Investigational Site
Cape Town
205.456.27002 Boehringer Ingelheim Investigational Site
Durban
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.
The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.
Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.
- Conditions
- Asthma
- Being tested
- tiotropium high dose, placebo, tiotropium low 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 high doseDrug
2 actuations once daily
placeboDrug
2 actuations once daily
tiotropium low doseDrug
2 actuations once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: tiotropium low dose |
| B | Experimental | Not described Receives: Drug: tiotropium high dose |
| C | Placebo comparator | Not described Receives: Drug: placebo |
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 12.
Measured values presented are actually adjusted means.
Measured: Baseline and 12 weeks
Secondary outcomes (14)
Trough FEV1 Change From Baseline
Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.
Measured values presented are actually adjusted means.
Measured: Baseline and 12 weeks
FVC peak0-3 Change From Baseline
Change from baseline in Maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak0-3h) after 12 weeks of treatment.
The measured values presented are actually adjusted means.
Measured: Baseline and 12 weeks
FEV1 AUC (0-3h) Change From Baseline
Change from baseline of area under the curve (AUC) from 0 to 3 hours for FEV1 (FEV1 AUC 0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
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 12 weeks
FVC AUC (0-3h) Change From Baseline
Change from baseline of area under the curve (AUC) from 0 to 3 hours for FVC (Forced vital capacity) (FVC AUC0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
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 12 weeks
Control of Asthma as Assessed by ACQ6 Score.
Change from baseline in Asthma Control Questionnaire (ACQ) 6 score measured at week 12
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. ACQ6 score is calculated as the mean of the responses to the first 6 questions of the ACQ6.
The measured values presented are actually adjusted means.
Measured: Baseline and 12 weeks
ACQ6 Score Responders
Responder rates based on the ACQ6 score after 12 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. ACQ6 is calculated as the mean of the responses to the first 6 questions of the ACQ6.
No statistical testing was performed on ACQ6 responders.
Measured: 12 weeks
Control of Asthma as Assessed by ACQ Total Score
Change from baseline in Asthma Control Questionnaire (ACQ) total score measured at week 12.
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 is calculated as the mean of the responses to all 7 questions.
The measured values presented are actually adjusted means.
Measured: Baseline and 12 weeks
ACQ Total Score Responders
Responder rates based on the ACQ total score after 12 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) No statistical testing was performed for ACQ total score responders.
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: 12 weeks
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 12.
The measured values presented are actually adjusted means.
Measured: Baseline and 12 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 12.
Measured values presented are actually adjusted means.
Measured: Baseline and 12 weeks
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 12.
Measured values presented are actually adjusted means
Measured: Baseline and 12 weeks
Time to First Severe Asthma Exacerbation During the 12-week Treatment Period.
Time in days to first severe asthma exacerbation during the 12 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 an initiation of treatment with systemic corticosteroids for at least 3 days or, in case of ongoing and pre-existing systemic corticosteroid therapy, requiring at least doubling of previous daily doses of systemic corticosteroids for at least 3 days.
Measured: 12 weeks
Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period.
Time in days to first asthma exacerbation during the 12 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: 12 weeks
Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests
Clinically relevant abnormalities for physical examination, ECG, vital signs and laboratory tests. New abnormal findings or worsening of baseline conditions were reported as adverse events.
Measured: From first drug administration until 30 days after last drug intake, up to 142 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 392 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
- NCT01277523
- Sponsor's protocol ID
- 205.456
- Other IDs
- 2010-021778-13
- Status last verified
- Oct 2014
- First submitted
- 13 Jan 2011
- Last updated
- 20 Oct 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, 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, Bernstein JA, Vandewalker M, Moroni-Zentgraf P, Verri D, Unseld A, Engel M, Boner AL. A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma. Eur Respir J. 2017 Jan 11;49(1):1601100. doi: 10.1183/13993003.01100-2016. Print 2017 Jan.
PubMed 27811070
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 mcg and 5 mcg Once Daily) Over 12 Weeks as add-on Controller Therapy on Top of Usual Care in Adolescents (12 to 17 Years Old) With Severe Persistent Asthma
- ClinicalTrials.gov ID
- NCT01277523
- Acronym / sponsor ID
- 205.456
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jan 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Posted 20 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution delivered via Respimat® inhaler (2.5 mcg and 5 mcg once daily) over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in adolescents (12 to 17 years old) with severe persistent asthma.
The primary objective of the trial is to demonstrate superiority of tiotropium (5 mcg and possibly 2.5 mcg once daily in the evening) over placebo with regard to the primary pulmonary function endpoint after 12 weeks of treatment.
Secondary objectives are to evaluate efficacy of tiotropium with regard to other endpoints, and to evaluate the safety of tiotropium, compared to placebo, as add-on controller therapy on top of usual care in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: tiotropium low dose |
| B | Experimental | Drug: tiotropium high dose |
| C | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- All patients and their parent(s) (or legally accepted representative) must sign and date respectively an informed assent and an informed consent consistent with International Conference on Harmonisation - Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to the patient's participation in the trial. A separate informed consent/assent is required for pharmacogenomic sampling.
- Male or female patients between 12 and 17 years of age (at date of informed consent/assent).
- All patients must have at least a 3-month history of asthma at the time of enrolment into the trial.
- All patients must have been on maintenance treatment with an inhaled corticosteroid either at stable high dose in combination with another controller medication, OR at stable medium dose in combination with two other controller medications, for at least 4 weeks before Visit 1.
- 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.
Key exclusion criteria (27 listed)
- Significant disease other than asthma.
- Abnormal haematology or blood chemistry.
- History of heart disease, and/or hospitalised for cardiac syncope or failure.
- Any unstable or life-threatening or requiring intervention or cardiac arrhythmia.
- Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
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 high dose2 actuations once daily | Drug | B |
| placebo2 actuations once daily | Drug | C |
| tiotropium low dose2 actuations once daily | Drug | A |
Primary outcome
FEV1 peak0-3 Change From Baseline
Time frame: Baseline and 12 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 12. Measured values presented are actually adjusted means.
14 secondary outcomes
Trough FEV1 Change From Baseline
Time frame: Baseline and 12 weeks
FVC peak0-3 Change From Baseline
Time frame: Baseline and 12 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 12 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 12 weeks
Control of Asthma as Assessed by ACQ6 Score.
Time frame: Baseline and 12 weeks
ACQ6 Score Responders
Time frame: 12 weeks
Control of Asthma as Assessed by ACQ Total Score
Time frame: Baseline and 12 weeks
ACQ Total Score Responders
Time frame: 12 weeks
Use of PRN Rescue Medication During the Day
Time frame: Baseline and 12 weeks
Use of PRN Rescue Medication During the Daytime
Time frame: Baseline and 12 weeks
Use of PRN Rescue Medication During the Night-time
Time frame: Baseline and 12 weeks
Time to First Severe Asthma Exacerbation During the 12-week Treatment Period.
Time frame: 12 weeks
Analysis of Time to First Asthma Exacerbation During the 12 Week Treatment Period.
Time frame: 12 weeks
Clinically Relevant Abnormalities for Physical Examination, ECG, Vital Signs and Laboratory Tests
Time frame: From first drug administration until 30 days after last drug intake, up to 142 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36472162Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Derived from this study: PubMed 31319851Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, Engel M, Zaremba-Pechmann L, Casale T, FitzGerald JM. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV1. Respir Res. 2019 Jul 18;20(1):159. doi: 10.1186/s12931-019-1119-6.
- Derived from this study: PubMed 27811070Hamelmann E, Bernstein JA, Vandewalker M, Moroni-Zentgraf P, Verri D, Unseld A, Engel M, Boner AL. A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma. Eur Respir J. 2017 Jan 11;49(1):1601100. doi: 10.1183/13993003.01100-2016. Print 2017 Jan.
- 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
69 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tiotropium high dose and tiotropium low dose in people with Asthma, run by Boehringer Ingelheim at 69 sites in 14 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 11 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in Ukraine, United States, Germany, Argentina, Hungary and 9 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 20 Oct 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 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01277523, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2014.