AsthmaPhase 2NCT01383499

A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma

A Phase 2 study testing Tiotropium bromide in people with Asthma, run by Boehringer Ingelheim at 24 sites in 6 countries.

Completed

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

Official record

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Trial summary

The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide. Read more about this study

Who is it for?: Ages 6 to 11 years
Conditions the study is for: Asthma
What is being tested?: Tiotropium bromide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 24 sitesin 6 countries
Study dates: Aug 2011to Sep 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
All patients' parents (or legally accepted caregivers) must sign and date an informed consent prior to any study procedures including medication washout and restrictions. In addition, an informed assent suitable for this age group has to be obtained from patients.
Male or female patients between 6 and 11 years of age (up to 1 day prior to their 12th birthday at Visit 1).
All patients must have at least a 6-month history of asthma at the time of enrolment into the trial.
All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose - a patient is eligible on =200 µg to =400 µg Budesonide DPI or equivalent.
All patients must be symptomatic (partly controlled) at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an ACQ mean score of =1.5.

Show all 10Show fewer

All patients must have a pre-bronchodilator FEV1 =60% and =90% of predicted normal at Visit 1. Variation of absolute FEV1 values of Visit 2 (pre-dose) as compared to values at Visit 2 (pre-bronchodilator) must be within ± 30%.
All patients must demonstrate an increase in FEV1 of =12% 15 to 30 min. after 200 µg salbutamol (albuterol) at Visit 1.
Patients must be able to inhale from the Respimat® inhaler correctly.
Patients must be able to perform all trial related procedures including technically acceptable spirometric manoeuvres according to current ATS/ERS standards and the use of the electronic diary/peak flow meter.

Who cannot join

Patients with any of the following characteristics will not be eligible for entry into this study:
Patients with a significant disease other than asthma.
Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1. For participation in PK sampling, a haemoglobin of less than 11.3 g/dL will be regarded as exclusion criterion.
Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation, catheter ablation etc.) or a change in drug therapy within the past year.
Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years.

Show all 13Show fewer

Patients with clinically significant lung diseases other than asthma, such as CF, or bronchopulmonary dysplasia.
Patients with known active tuberculosis.
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1.
Patients 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, BAC, EDTA or any other components of the tiotropium inhalation solution.
Patients with known narrow-angle glaucoma, or any other disease where anticholinergic treatment is contraindicated.
Patients with moderate to severe renal impairment, as defined by a creatinine clearance <50 mL/min./1.73 m2 BSA, as tiotropium is a predominantly renally excreted drug.

Trial locations and contacts

24 sites in 6 countries.

Country

City, postcode or hospital

24 sites in 6 countries

Latvia6 sites

205.425.37101 Boehringer Ingelheim Investigational Site
Baldone
205.425.37105 Boehringer Ingelheim Investigational Site
Balvi
205.425.37104 Boehringer Ingelheim Investigational Site
Daugavpils
205.425.37106 Boehringer Ingelheim Investigational Site
Dubulti
205.425.37102 Boehringer Ingelheim Investigational Site
Riga
205.425.37103 Boehringer Ingelheim Investigational Site
Riga

Other trials in Latvia

Hungary4 sites

205.425.36001 Boehringer Ingelheim Investigational Site
Budapest
205.425.36003 Boehringer Ingelheim Investigational Site
Budapest
205.425.36002 Boehringer Ingelheim Investigational Site
Mosdós
205.425.36004 Boehringer Ingelheim Investigational Site
Szeged

Other trials in Hungary

Lithuania4 sites

205.425.37004 Boehringer Ingelheim Investigational Site
Kaunas
205.425.37003 Boehringer Ingelheim Investigational Site
Tauragė
205.425.37001 Boehringer Ingelheim Investigational Site
Vilnius
205.425.37002 Boehringer Ingelheim Investigational Site
Vilnius

Other trials in Lithuania

Russia4 sites

205.425.07003 Boehringer Ingelheim Investigational Site
Moscow
205.425.07004 Boehringer Ingelheim Investigational Site
Moscow
205.425.07001 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.425.07002 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Germany3 sites

205.425.49005 Boehringer Ingelheim Investigational Site
Bochum
205.425.49004 Boehringer Ingelheim Investigational Site
Dresden
205.425.49002 Boehringer Ingelheim Investigational Site
Koblenz

Other trials in Germany

Ukraine3 sites

205.425.38002 Boehringer Ingelheim Investigational Site
Donetsk
205.425.38004 Boehringer Ingelheim Investigational Site
Kiev
205.425.38003 Boehringer Ingelheim Investigational Site
Zaporizhya

Other trials in Ukraine

About this study

Official title: A Phase II Randomised, Double-blind, Placebo-controlled Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Children 6 to 11 Yrs Old With Moderate Persistent Asthma

The aim of this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.

Conditions: Asthma
Being tested: Tiotropium bromide
Medical subject headings: Asthma

What participants receive

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

Tiotropium bromideDrug
inhalation solution administered via Respimat in 3 different doses
Tiotropium bromideDrug
inhalation solution administered via Respimat in 3 different doses
Tiotropium bromideDrug
inhalation solution administered via Respimat in 3 different doses
Tiotropium bromideDrug
inhalation solution administered via Respimat in 3 different doses

Study groups in NCT01383499
Study group	Role	What they receive
Treatment A	Experimental	patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler Receives: Drug: Tiotropium bromide
Treatment B	Experimental	patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler Receives: Drug: Tiotropium bromide
Treatment C	Experimental	patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler Receives: Drug: Tiotropium bromide
Treatment D	Placebo comparator	patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler Receives: Drug: Tiotropium bromide

What is being measured

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

Forced Expiratory Volume (FEV1) Peak (0-3h) Response
The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks

Secondary outcomes (10)

Trough FEV1 Response
The trough FEV1 is defined as the pre-dose FEV1 measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Forced Vital Capacity (FVC) Peak (0-3h) Response
The FVC peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FVC measured within the first 3 hours post dosing and the FVC baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
FVC Trough Response
The trough FVC response is defined as the pre-dose FVC measured just prior to the last administration of randomised treatment. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response
FEV1 (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response
FVC (AUC0-3h) will be calculated as the area under the curve from 0 to 3 hours using the trapezoidal rule divided by the observation time (3 hours) to report in litres. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Mean Morning Peak Expiratory Flow (PEF) Response
Mean morning PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Mean Evening PEF Response
Mean Evening PEF assessed by patients at home. Response was defined as the change from baseline. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use)
Mean number of inhalations (puffs) of unscheduled rescue salbutamol therapy during whole day (24 h, daytime and night-time use). Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: Baseline and 4 weeks
Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)
ACQ is a questionnaire consisting of seven point Likert scale ranging from 0 to 6, whereby 0 represents good control and 6 represents poor control of asthma. The scale describes the frequency and severity of asthma symptoms. Analysis adjusted for treatment, period, patient and baseline using a mixed model.
Measured: 4 weeks
Change From Baseline in Mean Number of Nighttime Awakenings
Mean number of nighttime awakenings due to asthma symptoms as assessed by patients eDiary incorporated in the AM3® device. Analysis adjusted for treatment, period, patient and baseline using a mixed model. The scores for this question used the following scale where: 1='Did not wake up', 2='Woke up once', 3='Woke up 2-5 times', 4='Woke up more than 5 times' and 5='Was awake all night'.
Measured: Baseline and last week of treatment (week 4)

Timeline

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

Aug 2011Sep 2012

First posted28 Jun 2011 (estimated)
Study startAug 2011
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01383499
Sponsor's protocol ID: 205.425
Other IDs: 2010-022458-18
Status last verified: Mar 2015
First submitted: 20 Jun 2011
Last updated: 15 Apr 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Vogelberg C, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Hamelmann E, Engel M, Szefler S. A randomised dose-ranging study of tiotropium Respimat(R) in children with symptomatic asthma despite inhaled corticosteroids. Respir Res. 2015 Feb 7;16(1):20. doi: 10.1186/s12931-015-0175-9.
PubMed 25851298

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Randomised, Double-blind, Placebo-controlled Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 µg, 2.5 µg and 5 µg) Delivered Via Respimat® Inhaler Once Daily in the Evening in Children 6 to 11 Yrs Old With Moderate Persistent Asthma
ClinicalTrials.gov ID: NCT01383499
Acronym / sponsor ID: 205.425
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Aug 2011
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 28 Jun 2011 (estimated)
Results: Posted 30 Dec 2013

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 this trial is to select an optimum dose may be selected based on bronchodilator efficacy, safety evaluations and pharmacokinetics of tiotropium bromide.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment A	Experimental	Drug: Tiotropium bromidepatients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler
Treatment B	Experimental	Drug: Tiotropium bromidepatients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler
Treatment C	Experimental	Drug: Tiotropium bromidepatients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler
Treatment D	Placebo comparator	Drug: Tiotropium bromidepatients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler

Who may qualify

Ages: 6 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (10 listed)

Patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:
All patients' parents (or legally accepted caregivers) must sign and date an informed consent prior to any study procedures including medication washout and restrictions. In addition, an informed assent suitable for this age group has to be obtained from patients.
Male or female patients between 6 and 11 years of age (up to 1 day prior to their 12th birthday at Visit 1).
All patients must have at least a 6-month history of asthma at the time of enrolment into the trial.
All patients must have been on maintenance treatment with inhaled corticosteroids at a stable medium dose - a patient is eligible on =200 µg to =400 µg Budesonide DPI or equivalent.

Key exclusion criteria (13 listed)

Patients with any of the following characteristics will not be eligible for entry into this study:
Patients with a significant disease other than asthma.
Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1. For participation in PK sampling, a haemoglobin of less than 11.3 g/dL will be regarded as exclusion criterion.
Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation, catheter ablation etc.) 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 bromideinhalation solution administered via Respimat in 3 different doses	Drug	Treatment D
Tiotropium bromideinhalation solution administered via Respimat in 3 different doses	Drug	Treatment C
Tiotropium bromideinhalation solution administered via Respimat in 3 different doses	Drug	Treatment B
Tiotropium bromideinhalation solution administered via Respimat in 3 different doses	Drug	Treatment A

Primary outcome

Forced Expiratory Volume (FEV1) Peak (0-3h) Response
Time frame: Baseline and 4 weeks
The FEV1 peak (0-3h) response is determined at the end of the 4 week treatment period. This is the difference between the maximum FEV1 measured within the first 3 hours post dosing and the FEV1 baseline measurement. Analysis adjusted for treatment, period, patient and baseline using a mixed model.

10 secondary outcomes

Trough FEV1 Response
Time frame: Baseline and 4 weeks
Forced Vital Capacity (FVC) Peak (0-3h) Response
Time frame: Baseline and 4 weeks
FVC Trough Response
Time frame: Baseline and 4 weeks
FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response
Time frame: Baseline and 4 weeks
FVC Area Under the Curve From 0 to 3 h (AUC0-3h) Response
Time frame: Baseline and 4 weeks
Mean Morning Peak Expiratory Flow (PEF) Response
Time frame: Baseline and 4 weeks
Mean Evening PEF Response
Time frame: Baseline and 4 weeks
Change From Baseline in the Number of Puffs of Rescue Medication Per Period (24 h, Daytime and Night-time Use)
Time frame: Baseline and 4 weeks
Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ)
Time frame: 4 weeks
Change From Baseline in Mean Number of Nighttime Awakenings
Time frame: Baseline and last week of treatment (week 4)

Results and safety

Results posted to the registry on 30 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tio R5/Placebo/Tio R1.25	27	26
Tio R1.25/Tio R5/Tio R2.5	24	24
Placebo/Tio R2.5/Tio R5	25	25
Tio R2.5/Tio R1.25/Placebo	25	25

Primary outcome: Forced Expiratory Volume (FEV1) Peak (0-3h) Response

Time frame: Baseline and 4 weeks. Least squares mean (Standard Error). Unit: Litre

Measure	Placebo n = 76	Tio R1.25 n = 75	Tio R2.5 n = 74	Tio R5 n = 75
Value	0.185 (0.025)	0.261 (0.026)	0.290 (0.026)	0.272 (0.026)

Placebo vs Tio R5: Mean Difference (Final Values): 0.087 (95% CI 0.042 to 0.132), p = 0.0002, Mixed model repeated measures (MMRM)
Placebo vs Tio R2.5: Mean Difference (Final Values): 0.104 (95% CI 0.059 to 0.149), p <.0001, Mixed model repeated measures (MMRM)
Placebo vs Tio R1.25: Mean Difference (Final Values): 0.075 (95% CI 0.030 to 0.120), p = 0.0011, Mixed model repeated measures (MMRM)

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

10 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 76 (0%)	0 of 76 (0%)	Not reported
Tio R1.25	0 of 75 (0%)	0 of 75 (0%)	Not reported
Tio R2.5	0 of 74 (0%)	0 of 74 (0%)	Not reported
Tio R5	0 of 76 (0%)	0 of 76 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25851298Vogelberg C, Moroni-Zentgraf P, Leonaviciute-Klimantaviciene M, Sigmund R, Hamelmann E, Engel M, Szefler S. A randomised dose-ranging study of tiotropium Respimat(R) in children with symptomatic asthma despite inhaled corticosteroids. Respir Res. 2015 Feb 7;16(1):20. doi: 10.1186/s12931-015-0175-9.
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

24 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tiotropium bromide in people with Asthma, run by Boehringer Ingelheim at 24 sites in 6 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 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Latvia, Hungary, Lithuania, Russia, Germany and 1 more country. 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 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Forced Expiratory Volume (FEV1) Peak (0-3h) Response (time frame: Baseline and 4 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 NCT01383499, 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 15 Apr 2015.