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Research Trial for Severe Uncontrolled Asthma (94 Weeks)

For condition: Asthma
Enrolling:
D5180C00016

Research Trial for Severe Uncontrolled Asthma (94 Weeks)

Study Summary

Recruiting children aged 5 to under 12 with severe uncontrolled asthma, to participate in this clinical research trial.  Must have documented treatment with a total daily dose of either medium or high dose inhaled corticosteroids (ICS) for at least 3 months, and documented treatment with at least one additional maintenance asthma controller medication.

Participants will receive investigational treatment (active study drug) or placebo, via subcutaneous injection.  Following the treatment period, participants may have the option to take part in the open-label extension period, and receive active study drug.  Study treatment and study-related assessments will be provided at no cost.  Reimbursement for study-related expenses may be provided.

Study participation will last up to 94 weeks and involve about 24 visits to the study centre, during that time.

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For more information about this trial, please visit ClinicalTrials.gov

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Privacy Policy

Last Revised: July 2024

Introductions

ResearchTrials.com is administered by Probity Medical Research Inc.

ResearchTrials.com is committed to respecting your Personal Information (defined below) and is aware of your concern for privacy when using ResearchTrials.com. Further to this commitment, we have adopted a company-wide Privacy Policy that guides how we collect, use, disclose, update and protect the information you provide to us and when we delete such information.

Probity complies with the Personal Information Protection and Electronic Documents Act (“PIPEDA”) and other applicable privacy and health information legislation. One of the underlying principles of this legislation is to obtain your consent in order to collect, use or disclose your Personal Information (defined below), and to ensure that you clearly understand the policies and practices regarding how this information is handled.

What is Personal Information?

“Personal Information” is information about an identifiable individual. This includes any information that can be linked to an individual’s identity, such as name, address, email, telephone number, age, gender, occupation, survey information, site registrations or any other information that might reasonably be used to identify someone. It does not apply to the information of non-individuals, such as corporations and other business entities and, generally speaking, to business contact information of physicians (“Physicians”) or pharmaceutical companies/medical device manufacturers (“Sponsors”).

What Personal Information do we Collect?

Probity attempts to collect and use information that is accurate, up-to-date, and as complete as possible. Probity collects Personal Information from you only when it is voluntarily provided. Registration is not required for use of ResearchTrials.com. Anyone can visit the site and read our content. We do not provide copyright to the materials on our website and expect that you comply with the laws in your jurisdiction with respect to further use of any material obtained from the website.

When visitors fill out the “contact us” section of ResearchTrials.com the following Personal Information is collected:

Name;
Phone number;
Email address.
Medical condition or area of interest; and
Your location (Country, City, State or Province, Zip Code or Postal Code);

How do we Obtain Consent?

By providing your Personal Information, you are consenting to our use of your Personal Information for the Purposes outlined below. Further, by using our website, you agree with the terms of this Privacy Policy.

You may withdraw this consent at any time or update your information. To withdraw your consent or to update your information, contact the Privacy Officer by mail at:

Probity Medical Research Inc.
Attention: Privacy Officer
139 Union Street East
Waterloo, Ontario, Canada N2J 1C4

How do we Use and Disclose Personal Information?

Probity collects your Personal Information for the following purposes (the “Purposes”):

to identify you;
to contact you about clinical research studies;
to enable a clinical research site in your area to contact you;
to confirm if your registration on ResearchTrials.com resulted in enrollment in any clinical trial, as well as the specific clinical trial(s) you enrolled in;
to ensure that we are achieving our goal of aiding enrollment in clinical trials;
to protect us both against error and fraud; and
to comply with legal requirements.

For Patients, the information you submit on ResearchTrials.com will be used for the above purposes. Because the clinical research sites are located in different countries, your personal information may be transmitted to your nearest research site (or research site you selected).

That research site may be in a different country than the location of the ResearchTrials.com database.

For Sponsors and Physicians, the information you submit on ResearchTrials.com will be used to contact you.

Personal Information will not be sold or rented and will not be exchanged with unaffiliated entities, except to fulfill the Purposes set out above, unless you are first notified and expressly consent to such transfer. Probity will seek to ensure that any third parties it shares your information with also comply with the terms of this Privacy Policy.

Safeguarding Personal Information

Probity is aware of your concern for privacy when using ResearchTrials.com. Probity takes reasonable steps to protect your Personal Information as you transmit your information from your computer to our websites and to protect your information from loss, misuse and unauthorized access, disclosure, alteration or destruction. All information transmitted to our website is secured using industry standard physical, technical, and administrative safeguards to secure data against foreseeable risks such as unauthorized use, access, disclosure, destruction, and modification. You should keep in mind, however, that no Internet transmission is ever 100% secure or error-free. In particular, e-mail sent to or from our website may not be secure, and you should therefore take special care in deciding what information you send to us via email.

Your Personal Information is kept in strict confidence; Probity utilizes appropriate security safeguards to keep your information confidential and secure. Only authorized personnel have access to your Personal Information and we do not release your Personal Information to third parties other than those third parties that are necessary to satisfy the Purposes (as defined above) for which the Personal Information was collected, including third party service providers. While we cannot guarantee that errors, loss or unauthorized access to your Personal Information will not occur, our procedures and systems are designed to protect your Personal Information from such events. When your Personal Information is no longer required to fulfill the identified Purposes, the information will be destroyed, erased, or made anonymous.

When you are contacted by a third party to participate in a clinical research study, Probity is no longer involved or responsible for collecting or safeguarding any further Personal Information you may provide to that third party.  As such, we recommend that you obtain information regarding their privacy policies before participating.

As we expect the need for participants in clinical research studies to be ongoing, the Personal Information you provide will be kept indefinitely. If at any time you wish to remove or update your information from our database, please contact our Privacy Officer by mail at:

Probity Medical Research Inc.
Attention: Privacy Officer
139 Union Street East
Waterloo, Ontario, Canada N2J 1C4

Access to Records and Other Information

Patients, Physicians and Sponsors have a right of access to their own Personal Information in a record that is in the custody or under the control of Probity, subject to some exceptions set out in applicable legislation. For example, organizations are required under PIPEDA to refuse to provide access to information that would reveal Personal Information about another individual. Further, organizations are authorized under PIPEDA to refuse access to Personal Information if disclosure would reveal confidential business information. Access may also be refused if the information is privileged or the information was generated in the course of a formal dispute resolution process.

If access is refused, in whole or in part, Probity will provide the reasons for the refusal. In cases where exceptions to access apply, Probity may withhold that information but will provide you with the remainder of the record.

If at any time you wish to access your personal information held by us, please contact us by mail at:

Probity Medical Research Inc.
Attention: Privacy Officer
139 Union Street East
Waterloo, Ontario, Canada N2J 1C4

IP Address

The ResearchTrials.com web server captures the Internet Protocol (IP) addresses of each connection to the website and the specific web pages visited during that connection. An IP address is a number assigned to your computer by your Internet Service Provider so you can access the Internet and is generally considered to be non-personally identifiable information because in most cases it changes each time you connect to the Internet. IP addresses may be used to diagnose problems with our server, report aggregate information, determine the fastest route for your computer to use in connecting to the website, and administer and improve the website. Although the IP address and related information collected is stored in the server log files, no individual is authorized to access those files for any purpose other than system maintenance. We may also use this information to help improve our websites and our services by better understanding our audience.

Probity may also collect non-personally identifiable information in aggregate form to track data such as the total number of visits to our websites, the number of visitors to each page of our websites, and the domain names of our visitors’ Internet service providers. We may use this information, which remains in aggregate form, to understand how our visitors use our websites so that we may make the websites better.

Cookies

Probity may also use “cookies” to administer our website, which are text packets sent by a server to a user’s web browser and then sent back unchanged by the user’s browser each time it accesses that server. Cookies are used for authenticating, tracking, and maintaining specific information about users, such as website preferences.  No personally identifiable information is exchanged via cookies.

Changes to the Policy

Probity reserves the right to modify or amend this Privacy Policy without notice and at any time and for any reason. An up-to-date version of this Privacy Policy may be obtained on our website.

Governing Law

This Privacy Policy is governed by the laws of Canada.  By submitting Personal Information to us, you understand that your Personal Information will be subject to the laws of Canada.

Questions and Concerns

You have the right to know how we protect your privacy and what you should expect from us. If you have questions or a complaint, you may contact our Privacy Officer by mail at:

Probity Medical Research Inc.
Attention: Privacy Officer
139 Union Street East
Waterloo, Ontario, Canada N2J 1C4

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