RecruitingOBSERVATIONAL

Canadian Observational Study Evaluating the Long-term IMPACT of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators on People With CF

This Canadian study aims to understand the long-term effects of special medicines, like Trikafta, for people with cystic fibrosis (CF). Researchers will observe how these treatments impact health over many years, looking at health trends and information. The goal is to see which treatments are most effective and help doctors understand how to tailor care for each individual. By collecting routine health data, survey answers from patients, and samples for future research, this study hopes to improve the lives of people with CF. It's an important step in making sure people with CF get the best possible care for the long haul.

At a glance

Status

Recruiting

Sponsor

University of British Columbia

Enrolment target

500

Start

01 Nov 2021

Estimated completion

31 Dec 2027

Cystic Fibrosis

What is this study about?

Imagine you have cystic fibrosis (CF), and you're taking a special medicine like Trikafta. This medicine is designed to help your body work better, but how well does it work over many years? That's what this important Canadian study wants to find out.

Researchers are looking closely at people across Canada who are taking these types of CF medicines, often called 'modulators'. They want to see how these treatments affect your health in the long run. Are people staying healthier? Are they having fewer problems? By carefully watching and collecting information, the study hopes to learn which treatments are most effective and how they can be made even better for each person with CF.

This kind of study, called 'observational', means that you'd continue getting your usual medical care, and the researchers would gather information from your routine health check-ups. They'll also ask you to complete some surveys about how you're feeling and your quality of life. Sometimes, they might also collect samples, like blood, if you agree. All this information helps paint a clearer picture of how these valuable medicines are working in the real world.

Key takeaways

This study looks at how well CF medicines like Trikafta work long-term.
It aims to improve future care for people with cystic fibrosis.
You'll continue your usual CF treatment; no new medicines are given.
Information is collected from your routine doctor visits and surveys.
Open to all ages and genders with cystic fibrosis in Canada.
You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, you need to be a person with cystic fibrosis in Canada who is already taking a special CF medicine called a 'modulator' or is about to start one within 30 days. This also includes people who are planning to switch from one modulator medicine to another within 30 days.

You also need to be part of the Canadian Cystic Fibrosis Registry, which is a database that keeps track of health information for people with CF in Canada. If you're under 18, your parent or legal guardian would need to agree, and you would also need to give your agreement if you're old enough.

However, you wouldn't be able to join if your doctor has told you that you shouldn't take CF modulator medicines because of other health reasons. This study is open to both adults and children, and to people of all genders.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have cystic fibrosis?
Are you currently taking a CF modulator medicine (like Trikafta), or starting one soon?
Are you planning to switch between CF modulator medicines soon?
Are you part of the Canadian Cystic Fibrosis Registry?
Has your doctor said you can take CF modulator medicines?

Answer every question to see your result.

What does participation involve?

If you join this study, you won't need to change your current medical care. You'll continue seeing your own doctors and receiving your usual CF treatments. The researchers will gather information from your routine medical appointments and health records. You'll also be asked to complete surveys about your health and how you're feeling. In some cases, you might be asked to provide samples, such as blood, but this would always be discussed with you first. There are no extra hospital visits or special medicines given as part of this study; it simply involves observing your health over time. The total duration of your participation would depend on how long the study continues to collect data.

Potential risks and benefits

Participating in this study might not directly benefit you, as you'd be receiving your standard medical care. However, the information gathered could greatly help other people with CF in the future by improving our understanding of these medicines. There are no new or extra risks from taking part, beyond the usual risks associated with your routine medical care and treatments. Providing survey answers and samples is generally very safe. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

British Columbia Children's Hospital
Verified postcode
Vancouver, Canada· Recruiting
St Paul's Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What kind of medicine will I take in this study?

You will continue to take the CF modulator medicine your doctor has prescribed, like Trikafta. The study doesn't ask you to take any new medicine.

Will I have to go to extra doctor appointments?

No, you will not have extra doctor appointments just for this study. The researchers will gather information from your regular check-ups.

What kind of information will the study collect about me?

The study will collect information from your health records, ask you to fill out surveys about how you're feeling, and sometimes ask for samples like blood.

Is this study only for adults?

No, this study is open to both children and adults with cystic fibrosis.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect the medical care you receive.

How to find out more

Alam Lakhani

alam.lakhani@cw.bc.ca 604-875-2345 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.