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A dose finding study in patients aged 12 and above with cystic fibrosis using the Respimat® inhaler

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Mucociliary Clearance

Trial status

Project in Setup

Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Phase II

Full title

A 4-week study to investigate different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler as an add-on therapy to standard of care

The BALANCE CF™1 trial will compare different doses of a new medication ‘BI 1265162’ and determine if this new medication is safe and effective to treat CF. This trial will also investigate how subjects’ bodies absorb and digest BI 1265162 by measuring study participants blood at specific intervals after taking the medication. The new medication BI1265162 is an ENaC inhibitor which means it blocks the epithelial sodium (Na) channel (ENaC) of the airway surface layer. By blocking this channel, your mucus should be less sticky which may improve your lung function. The medication is an inhaled oral medication using the Respimat® device. You will take the inhaler on top of your current CF treatment, whatever CF genes you have.If you are suitable to join the study, you will be randomly assigned to receive one of the different doses of BI1265162 or placebo. The trial will last approximately 7 weeks and involve 6 visits to the hospital. You will be asked to complete questionnaires, have blood samples, an ECG, lung function tests and a Multiple Breath Washout Test.

Trial Reference Number

120382

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

Respimat inhaler.

Recruitment target
the number of participants who need to be recruited for the trial in the UK

96

Last edited date

13 November 2019

CF sponsor

Boehringer Ingelheim

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older
  • FEV1 ≥ 40% and ≤ 90%
Top exclusion criteria
  • Evidence of acute upper or lower respiratory tract infection
  • Pulmonary exacerbation requiring use of antibiotics within 4 weeks prior to randomisation