Efficacy and Safety of 2 Doses of Tiotropium Respimat Compared to Placebo in Adolescents With Severe Persistent Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01277523

Run by

Boehringer Ingelheim

People needed

392

Starts

2011-01-01

Expected to finish

2013-10-01

Last updated by the study team

2014-10-20

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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).

You may not qualify if…

• 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.
• 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.

Where it is running

• 205.456.01008 Boehringer Ingelheim Investigational Site — Normal, Illinois, United States
• 205.456.01003 Boehringer Ingelheim Investigational Site — Baltimore, Maryland, United States
• 205.456.01007 Boehringer Ingelheim Investigational Site — Columbia, Missouri, United States
• 205.456.01002 Boehringer Ingelheim Investigational Site — Bellevue, Nebraska, United States
• 205.456.01001 Boehringer Ingelheim Investigational Site — Rockville Centre, New York, United States
• 205.456.01005 Boehringer Ingelheim Investigational Site — Cincinnati, Ohio, United States
• 205.456.01006 Boehringer Ingelheim Investigational Site — Summerville, South Carolina, United States
• 205.456.54002 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 205.456.54006 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 205.456.54008 Boehringer Ingelheim Investigational Site — Capital Federal, Argentina
• 205.456.54005 Boehringer Ingelheim Investigational Site — Mendoza, Argentina
• 205.456.54003 Boehringer Ingelheim Investigational Site — San Juan Bautista, Argentina
• 205.456.54004 Boehringer Ingelheim Investigational Site — San Miguel de Tucumán, Argentina
• 205.456.54009 Boehringer Ingelheim Investigational Site — San Miguel de Tucumán, Argentina
• 205.456.61002 Boehringer Ingelheim Investigational Site — Parkville, Victoria, Australia
• 205.456.61001 Boehringer Ingelheim Investigational Site — Perth, Western Australia, Australia
• 205.456.35902 Boehringer Ingelheim Investigational Site — Plovdiv, Bulgaria
• 205.456.35901 Boehringer Ingelheim Investigational Site — Rousse, Bulgaria
• 205.456.35903 Boehringer Ingelheim Investigational Site — Sofia, Bulgaria
• 205.456.49008 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 205.456.49001 Boehringer Ingelheim Investigational Site — Bochum, Germany
• 205.456.49004 Boehringer Ingelheim Investigational Site — Frankfurt, Germany
• 205.456.49005 Boehringer Ingelheim Investigational Site — Kehl, Germany
• 205.456.49003 Boehringer Ingelheim Investigational Site — Koblenz, Germany
• 205.456.01004 Boehringer Ingelheim Investigational Site — Stockton, California, United States

Full record on ClinicalTrials.gov

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