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Search result from the Trials Tracker

A trial investigating the effect of a sinus rinse in people with CF

This trial has been archived

People with with CF often have bacterial infection in their air ways. There is great interest in the different types of bacteria found within these infections. This clinical trial looks at whether a novel sinus rinse device (that incorporates manuka honey) could help clear infection or reduce the amount and/or types of bacteria found within the upper airway. This study assesses the changes in the Sino-Nasal Outcome Test (SNOT-22) scores along with any changes in quality of life, before and after the use of a sinus rinse device for 30 days. In addition to this, the amount and types of...

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Trials Tracker ID: TT002111
Age range: 18 years and older
Length of participation: 4 months
Trial status: Closed with results
Therapeutic approach: Anti-Infective

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A study to investigate the safety of Kaftrio® in 2 to 5 year olds with CF (VX20-445-111)

This trial has been archived

This study is to learn more about the safety of taking Kaftrio® (elexacaftor in combination with tezacaftor and ivacaftor) and how well it works in 2- to 5-year-olds with CF. All three of the medicines which make up Kaftrio® are called CFTR modulators. CFTR modulators help the faulty CFTR protein to function properly. Everyone in the study will receive the study medications. Study participants will be asked to visit the CF clinic around 8 times over 6 months (24 weeks), with an additional follow-up visit approximately 4 weeks after finishing the study medications. During these visits, the research team will...

This study found that Kaftrio was generally safe and well tolerated in children aged 2 to 5 years. These findings are consistent with studies in older age groups.

In this study, children taking Kaftrio had meaningful improvements in CFTR function and lung function. These results support the use of ELX/TEZ/IVA in children with CF who are as young as 2 years of age.

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Trials Tracker ID: TT002106
Age range: 2 to 5 years
Length of participation: 7 months (28 weeks)
Trial status: Closed with results
Therapeutic approach: Restore CFTR Function

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A study of the combined long-term safety of three CFTR modulator medicines in people with cystic fibrosis (VX19 445 115)

In order to take part in this study you will already be taking part in the VX18-445-109 study. VX-445 is a medicine being studied for how well it works and how safe it is in people with cystic fibrosis. Your participation in this study will help us learn more about the safety of taking VX-445 in combination with tezacaftor and ivacaftor for a long time. All three of the medicines are CFTR modulators which means that they help the faulty CFTR protein to function properly. Tezacaftor is already approved for use and is what is known as a corrector. Ivacaftor...

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Trials Tracker ID: TT002096
Age range: 12 years and older
Trial status: Closed with results
Therapeutic approach: Restore CFTR Function

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A long-term extension study of the combined effects of three CFTR modulator medicines in people with cystic fibrosis aged 6 and older (VX19 445 107)

VX-445 is a medicine being studied for how well it works and how safe it is in people with cystic fibrosis. This study is an extension of existing study (VX18-445-106) to look at the long-term efficacy and safety of VX-445 in combination with tezacaftor and ivacaftor. All three are CFTR modulators which means that they help the faulty CFTR protein to work properly. Tezacaftor is already approved for use and is what is known as a corrector. Ivacaftor is also already approved for use and is what is known as a potentiator. VX-445 is a corrector. Participants from the previous...

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Trials Tracker ID: TT002091
Age range: 6 years and older
Trial status: Recruitment complete
Therapeutic approach: Restore CFTR Function

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VX19-445-116 A study of three CFTR modulator medicines for how well they work together and their safety in people with cystic fibrosis aged 6 to 11 with one F508del mutation and one minimal function mutation

In order to take part in this study you will have one F508del mutation and one minimal function mutation, and be aged 6 to 11. Elexacaftor (VX-445) is a medicine being studied for how well it works and how safe it is in people with cystic fibrosis. Your participation in this study will help us learn more about the safety of taking elexacaftor in combination with tezacaftor and ivacaftor. All three of the medicines are CFTR modulators which means that they help the faulty CFTR protein to function properly. Tezacaftor is already approved for use and is what is known...

Kaftrio treatment was generally safe and well tolerated in patients aged 6 – 11 years with one F508del mutation and one minimal function mutation. No new safety concerns were identified. These results support the use of Kaftrio in children with these gene variants.

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Trials Tracker ID: TT002086
Age range: 6 to 11 years
Trial status: Closed with results
Therapeutic approach: Restore CFTR Function

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A study of the combined effects of three CFTR modulator medicines in children with cystic fibrosis aged 6 to 11 (VX18-445-106)

VX-445 is an investigational medicine being studied to see how well it works and how safe it is in children with cystic fibrosis aged 6 to 11 years, when taken in combination with tezacaftor and ivacaftor. All three medicines are CFTR modulators which means that they help the faulty CFTR protein found in cystic fibrosis to work properly. Tezacaftor is already approved for use and is what is known as a ‘corrector’. Ivacaftor is also already approved for use and is what is known as a ‘potentiator’. VX-445 is a corrector

These results are consistent with previous studies in older age groups that show this treatment is safe and effective for people who have at least one F508del gene variant. It seemed to be more effective than existing modulator treatments. This study adds to the evidence supporting the use of Kaftrio in this age group.

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Trials Tracker ID: TT002081
Age range: 6 to 11 years
Trial status: Closed with results
Therapeutic approach: Restore CFTR Function