Thank you for taking an interest in the feline atopic skin syndrome (FASS) clinical trial. You and your cat’s involvement will play a vital role in understanding how to better treat cats with atopic dermatitis (atopy/FASS). The most consistent feature of FASS is chronic recurrent pruritus (itchiness). A treatment is now being tested in cats. A preliminary safety study in cats involving the administration of twice daily oral doses of this treatment was conducted for 28 days and was well tolerated. This chewable formulation was accepted by 82.7% of cats over three consecutive days of administration. This study will assess the formulation’s effectiveness in reducing inflammation and itching associated with atopy. It will also assess the palatability of the chewable tablets under field conditions. Your cat will be randomly assigned to one of four treatment groups, either the treatment containing the new active, or a placebo treatment. You and your vet won’t know which of the treatments your cat is receiving, to avoid any bias. We expect the treatment will improve your cat’s wellbeing without unwanted side effects. The study is being conducted by an independent veterinary research company called Invetus. Neither your veterinarian nor Invetus have a commercial interest in the medication being tested in this study.
Frequently Asked Questions
What the study involves for you and your cat:
At the first visit: The veterinarian will assess your cat’s eligibility to be on the study and the severity of your cat’s atopy. If your cat is enrolled in the study, your cat will be randomly assigned to 1 of 4 treatment groups. Blood and urine will be collected for complete blood count and biochemistry to make sure your cat is fit and well. Skin swabs will also be collected. Skin swabs involve a cotton swab (like a large cotton bud) being wiped across the skin to collect skin bacteria. The veterinarian will demonstrate how to administer the product. You will treat your cat with the product daily for approximately 28 days (4 weeks). Invetus staff will show you how to record your treatment of your cat and if they liked the medication using either a website or paper forms. You will receive a phone call from an Invetus staff member in the first week to help you with any questions you may have.
At Day 14 (+/-3): You and your cat will visit your veterinarian again. Your cat’s skin will be checked, and a blood sample collected to check your cat’s health. This is also a good opportunity for you to discuss how things are going and have any questions answered. You will be asked to answer a questionnaire about your cat’s itchiness, and again Invetus staff will be present to assist you with any questions you have and collect any completed forms.
At Day 28 (+/-3): You and your cat will visit your veterinarian for a final time. Your cat’s skin will be assessed, and you will be asked to complete the same questionnaire again. A final blood sample, and skin swabs that were collected at Day 0 will be repeated to make sure that your cat remains fit and well at the completion of the study. At the end of the study all remaining medication, bottle and forms must be returned and Invetus staff will check through the paperwork with you and once everything is checked off, we will sign you off on the completion of your vital role in the study. At home, please remember to log any issues you may have such as missing a dose. You will also be required to record any abnormal health observations. If you are concerned about your cat at all, please contact your cat’s veterinarian and record your concerns. You will continue to feed your cat their regular diet and administer veterinary treatments exactly as your cat’s veterinarian instructs throughout the study. Please call at any time if you are unsure as to what to do.
Why do I need to return all medication and paperwork at the Day 28 (+/-3) visit?
All tablets must be accounted for at the end of the study because this is an Investigative Veterinary Product.
What are the benefits:
There is no cost to you for involvement in the study. If you and your cat successfully complete the study, you will be rewarded with a $350 clinic credit. This will be added to your account once all paperwork and remaining product are returned to your veterinarian. Most of all, your cat will potentially benefit from the treatment and you will be contributing to the development of a new and potentially very useful treatment in the management of atopy in cats.
Costs:
As well as the $350 voucher, the study will pay for the three visits to the veterinarian, the blood, urine and skin tests, and the trial medication. If your cat experiences any untoward health problems during the study which are due to the trial medication (an Adverse Event), the study will pay for all reasonable and necessary veterinary fees and expenses related to the adverse event. If your animal experiences health problems which are NOT related to the trial medication, you will be responsible for the associated costs as usual.
Who are Invetus?
Invetus is a veterinary research company that runs clinical trials across Australia and New Zealand. We provide independent veterinary research services to answer questions for animal health companies and have consulted with more than 200 different organisations looking to improve the health of companion and production animals.
What if I am unsure what to do?
Call your cat’s veterinary clinic or the Invetus research team if you are unsure about any aspect of the study. It is important that we conduct this study as well as we can, so please ask if you have any questions. Your cat’s veterinarian and the Invetus Research team are happy to help. What if I can’t make my appointment? Being on time for these appointments is important as they are more complex than usual and need to be done at a particular time in the study. Please let your veterinary clinic know if you are going to be late or need to change an appointment so that we can work with you to care for your cat during the study.
Potential risks:
A preliminary safety study in cats involving the administration of twice daily oral doses of the Investigational Veterinary Product was conducted for 28 days and was reported to be well tolerated. An Invetus staff member will call you within the first week to see how you and your pet are going. The veterinarian will also carefully check your cat at each visit. A free visit to the vet will be organised if there are any concerns. Your veterinarian and Invetus will be available to help you throughout the study.
Confidentiality:
Your identity is treated as confidential and will not be made public unless disclosure is required by law. Data obtained from this study will be given to the Sponsor or their representatives and may be published or provided to regulatory agencies.
Voluntary participation/withdrawal:
Your participation is voluntary, and you may end your participation in this study at any time. However, your withdrawal may affect the success of the overall study so please do not proceed beyond this point unless you are committed to successfully completing your part in the study.
Your participation in the study may be ended by your veterinarian, or by the Sponsor without your consent. Failure to follow instructions may necessitate the removal of your cat from the study. If you withdraw, or your participation in the study is ended, you are obliged to return all study documentation and product to your veterinarian.
If in doubt, ask for help.
Please contact your veterinarian or Invetus staff and ask for help if you are unsure about anything to do with how to give the treatment to your cat or any other aspect of the study.
