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

NCT ID: NCT01383499

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-09-30

Brief 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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment A

patients inhale 2 puffs (low dose) once daily in the evening via Respimat inhaler

Group Type: EXPERIMENTAL

Tiotropium bromide

Intervention Type: DRUG

inhalation solution administered via Respimat in 3 different doses

Treatment B

patients inhale 2 puffs (medium dose) once daily in the evening via Respimat inhaler

Group Type: EXPERIMENTAL

Tiotropium bromide

Intervention Type: DRUG

inhalation solution administered via Respimat in 3 different doses

Treatment C

patients inhale 2 puffs (high dose) once daily in the evening via Respimat inhaler

Group Type: EXPERIMENTAL

Tiotropium bromide

Intervention Type: DRUG

inhalation solution administered via Respimat in 3 different doses

Treatment D

patients inhale 2 puffs of placebo inhalation solution matching tiotropium once daily in the evening via Respimat inhaler

Group Type: PLACEBO_COMPARATOR

Tiotropium bromide

Intervention Type: DRUG

inhalation solution administered via Respimat in 3 different doses

Interventions

Tiotropium bromide

inhalation solution administered via Respimat in 3 different doses

Intervention Type: DRUG

Tiotropium bromide

inhalation solution administered via Respimat in 3 different doses

Intervention Type: DRUG

Tiotropium bromide

inhalation solution administered via Respimat in 3 different doses

Intervention Type: DRUG

Tiotropium bromide

inhalation solution administered via Respimat in 3 different doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

205.425.49005 Boehringer Ingelheim Investigational Site

Bochum, , Germany

205.425.49004 Boehringer Ingelheim Investigational Site

Dresden, , Germany

205.425.49002 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

205.425.36001 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

205.425.36003 Boehringer Ingelheim Investigational Site

Budapest, , Hungary

205.425.36002 Boehringer Ingelheim Investigational Site

Mosdós, , Hungary

205.425.36004 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

205.425.37101 Boehringer Ingelheim Investigational Site

Baldone, , Latvia

205.425.37105 Boehringer Ingelheim Investigational Site

Balvi, , Latvia

205.425.37104 Boehringer Ingelheim Investigational Site

Daugavpils, , Latvia

205.425.37106 Boehringer Ingelheim Investigational Site

Dubulti, , Latvia

205.425.37102 Boehringer Ingelheim Investigational Site

Riga, , Latvia

205.425.37103 Boehringer Ingelheim Investigational Site

Riga, , Latvia

205.425.37004 Boehringer Ingelheim Investigational Site

Kaunas, , Lithuania

205.425.37003 Boehringer Ingelheim Investigational Site

Tauragė, , Lithuania

205.425.37001 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

205.425.37002 Boehringer Ingelheim Investigational Site

Vilnius, , Lithuania

205.425.07003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

205.425.07004 Boehringer Ingelheim Investigational Site

Moscow, , Russia

205.425.07001 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

205.425.07002 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

205.425.38002 Boehringer Ingelheim Investigational Site

Donetsk, , Ukraine

205.425.38004 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

205.425.38003 Boehringer Ingelheim Investigational Site

Zaporizhya, , Ukraine

Countries

Germany; Hungary; Latvia; Lithuania; Russia; Ukraine

References

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.

Reference Type: DERIVED

PMID: 25851298 (View on PubMed)

Other Identifiers

2010-022458-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205.425

Identifier Type: -

Identifier Source: org_study_id