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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01383499
• Date of registration: 20/06/2011
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim
• Public title: A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma
• Scientific 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
• Date of first enrolment: August 2011
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01383499
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Germany, Hungary, Latvia, Lithuania, Russian Federation, Ukraine

Contacts

• Name: Boehringer Ingelheim
• Affiliation: Boehringer Ingelheim

Key inclusion & exclusion criteria

Inclusion criteria:

Patients must meet all of the following inclusion criteria to be eligible for enrollment
into this study:

1. 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.

2. Male or female patients between 6 and 11 years of age (up to 1 day prior to their 12th
birthday at Visit 1).

3. All patients must have at least a 6-month history of asthma at the time of enrolment
into the trial.

4. 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.

5. 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.

6. 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%.

7. All patients must demonstrate an increase in FEV1 of =12% 15 to 30 min. after 200 µg
salbutamol (albuterol) at Visit 1.

8. Patients must be able to inhale from the Respimat® inhaler correctly.

9. 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.

Exclusion criteria:

Patients with any of the following characteristics will not be eligible for entry into this
study:

1. Patients with a significant disease other than asthma.

2. 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.

3. 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.

4. 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.

5. Patients with a malignancy for which the patient has undergone resection, radiation
therapy or chemotherapy within the last five years.

6. Patients with clinically significant lung diseases other than asthma, such as CF, or
bronchopulmonary dysplasia.

7. Patients with known active tuberculosis.

8. 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.

9. 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).

10. Patients with known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other
components of the tiotropium inhalation solution.

11. Patients with known narrow-angle glaucoma, or any other disease where anticholinergic
treatment is contraindicated.

12. 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.



Age minimum: 6 Years
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Tiotropium bromide

Primary Outcome(s)

Forced Expiratory Volume (FEV1) Peak (0-3h) Response [Time Frame: Baseline and 4 weeks]

Secondary Outcome(s)

Mean Morning Peak Expiratory Flow (PEF) Response [Time Frame: Baseline and 4 weeks]

Trough FEV1 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 Evening PEF Response [Time Frame: Baseline and 4 weeks]

Change From Baseline in Mean Number of Nighttime Awakenings [Time Frame: Baseline and last week of treatment (week 4)]

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]

FEV1 Area Under the Curve From 0 to 3 h (AUC0-3h) Response [Time Frame: Baseline and 4 weeks]

FVC Trough Response [Time Frame: Baseline and 4 weeks]

Control of Asthma as Assessed by Asthma Control Questionnaire (ACQ) [Time Frame: 4 weeks]

Forced Vital Capacity (FVC) Peak (0-3h) Response [Time Frame: Baseline and 4 weeks]

Secondary ID(s)

205.425

2010-022458-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer

Results

• Results available: Yes
• Date Posted: 30/12/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01383499