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Clinical Trials/EUCTR2010-022458-18-LV
EUCTR2010-022458-18-LV
Active, not recruiting
Not Applicable

A phase II randomised, double-blind, placebo-controlled incomplete cross-over trial with 4-week treatment periods to evaluate efficacy and safety of tiotropium inhalation solution (doses of 1.25 µg, 2.5 µg and5 µg) delivered via Respimat® inhaler once daily in the evening in children 6 to 11 yrs old with moderate persistent asthma

Boehringer Ingelheim Pharma GmbH & Co. KG0 sites104 target enrollmentMarch 23, 2011
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ConditionsModerate persistent asthma in children 6 to 11 years oldMedDRA version: 14.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsSpiriva Respimat 2.5 microgram, solution for inhalation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Moderate persistent asthma in children 6 to 11 years old
Sponsor
Boehringer Ingelheim Pharma GmbH & Co. KG
Enrollment
104
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 23, 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. All patients' parents (or legally accepted caregivers) must sign and date an informed consent consistent with ICH\-GCP guidelines and local legislation prior to participation in the trial, i.e. prior to any study procedures including medication wash\-out and restrictions. In addition, an informed assent suitable for this age group has to be obtained from patients. A separate informed consent is required for pharmacogenomic sampling (consent for pharmacogenomic sampling is not a prerequisite for study entry).
  • •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, either as mono treatment or in combination with a LABA or leukotriene modifier for at least 4 weeks before Visit 1\.
  • •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 1 (pre\-bronchodilator) as compared to Visit 2 (pre\-dose) must be within ±30%.
  • •7\. All patients must have an increase in FEV1 of \=12% 15 to 30 min. after 200 mcg 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 ATS/ERS standards and the use of the electronic diary/peak flow meter.
  • •Are the trial subjects under 18? yes

Exclusion Criteria

  • •1\. Patients with a significant disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient’s ability to participate in the trial.
  • •2\. Patients with clinically relevant abnormal screening haematology or blood chemistry, 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 chnage 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.

Outcomes

Primary Outcomes

Not specified

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