How long will the WILLOW Study take?
The WILLOW Study will last for up to 34 weeks (just over 8 months) for each participant. This includes:
- A 6-week Screening period
- A 24-week Treatment period
- A 4-week Follow-up period.
How many visits will I need to attend?
You will be required to attend 10 visits to the study centre in total:
- One for Screening
- 8 during the Treatment period
- One for the End of Study visit.
What treatment will I be given?
If you are eligible and you choose to take part in this study, you will be allocated to one of three treatment groups:
- INS1007 10-mg dose
- INS1007 25-mg dose
- Dummy (placebo) treatment
What procedures and assessments are involved?
At each visit, you will need to have different assessments and procedures performed, ranging from filling out forms and answering questionnaires, to having blood and urine samples taken. These will change at the different visits. You will also have various physical measurements taken, such as your height, weight and blood pressure, as well as an electrocardiogram (ECG), which measures the electrical activity of your heart. You may have to undergo a Computed Tomography (CT) scan if you have not previously had confirmation of a Non-Cystic Fibrosis Bronchiectasis (NCFBE) diagnosis.
What safety measures are in place?
Your health will be monitored throughout the WILLOW Study and at each study visit you will be asked to report any side effects you have experienced.
In the case of an emergency, there is a procedure in place to find out what treatment you are on so that you can receive the correct care.
If it becomes clear that the risks over weigh the potential benefits of the study, the study will be stopped. Also, the participation of individual patients may be stopped if side effects are too serious.
What if I am unable to attend a visit?
You will need to contact the study centre staff as soon as possible to try and rearrange your visit. It is important to attend all visits within the time range permitted (within 3 days either side of the date), so we ask that you are committed to attending the agreed visit times as much as possible.
Will it cost me anything to participate in the WILLOW Study?
You do not have to pay for the study medication, study visits or any tests that are part of the study. You may be reimbursed for necessary expenses (e.g the cost of your transport to and from visits).
Insmed Incorporated is the sponsor of the WILLOW trial. This study has been approved by the Institutional Review Board/Ethics Committee and/or Competent Authority in this country.
For a description of this clinical trial please click here and for further information about Insmed Incorporated please click here.