Cystic Fibrosis Trial, Recruiting NCT06940531 Sponsor: Alexander Horsley Condition: Cystic Fibrosis
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Cystic Fibrosis Trial, Recruiting

NCT06940531
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For adults with cystic fibrosis (CF):

  • You have a confirmed diagnosis of CF, based on genetic testing and/or a sweat test result above 60mmol/L, along with symptoms consistent with CF
  • You are 16 years old or older and receive your CF care at a UK Adult CF Centre
  • You have had at least one chest flare-up (lung exacerbation) treated with antibiotics (by mouth or through a drip) in the past 12 months
  • You are able to understand the study information, agree to take part, and send samples from home
  • You already have a spirometry device at home (a machine to measure your lung function) and know how to use it

For Group B participants only (additional requirements):

  • You are willing to attend extra in-person visits at 4 weeks, 26 weeks, and if you become unwell

For Group B participants at Manchester doing home monitoring (additional requirements):

  • You have wireless internet (Wi-Fi) at home
  • You are willing to allow researchers to visit your home to set up monitoring equipment, collect it at the end of the study, and carry out occasional checks or air sampling visits

For children with cystic fibrosis (ages 5–16):

  • You have a confirmed diagnosis of CF, based on genetic testing and/or a sweat test result above 60mmol/L, along with symptoms consistent with CF
  • You receive care at an eligible Paediatric CF Centre
  • You are between 5 and 16 years old
  • You have had at least one chest flare-up treated with antibiotics
  • You (and/or your parent or guardian) are able to understand the study and are willing to take part, including helping with collecting samples at home
  • You have a home spirometry device and are able to use it

For healthy volunteers:

  • You are a healthy male or female aged between 16 and 65 years old
  • You do not have any active lung condition, long-term inflammatory condition, or ongoing infection
  • You have not taken any antibiotics or anti-inflammatory medicines (including steroid inhalers or steroid tablets) for at least 90 days
  • You have not had any recent viral illness (such as a cold or flu) in the past 4 weeks
  • You are willing to sign a consent form and provide the required samples

Who may not be able to join:

  • You are unable to produce a sputum (phlegm) sample — either on your own or with help — at your first visit (though the visit can be repeated up to two more times if needed)
  • At your first visit, you are not feeling stable — for example, your symptoms have recently changed, you have new cold or flu symptoms, or you are currently taking extra antibiotics or antiviral medicines (you should have finished any such extra treatment at least 4 weeks before your first visit)
  • You have an active tuberculosis (TB) infection
  • You have active ABPA (a type of allergic lung condition linked to a fungus), meaning you are being treated for it now, have been treated within the last 12 months, or are expected to need treatment in the next 12 months (confirm with trial site)
  • You are taking long-term oral steroids at a dose equivalent to 10mg or more of prednisolone per day
  • You are taking any other long-term medication that suppresses your immune system
  • You have a non-TB mycobacteria (NTM) lung infection and are currently on treatment to clear it — though people with a long-term NTM infection who are not being treated and are not expected to start treatment in the next 12 months may still be eligible
  • You have previously shown that you are unable or unwilling to use a home spirometry device regularly
  • You have any other health condition or circumstance that the study doctor feels would make it difficult or unsafe for you to take part
  • For home monitoring only: there are any safety concerns about researchers visiting your home

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 01612915869

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Alexander Horsley
Registry
ClinicalTrials.gov
Start date
16 May 2025
Est. completion
31 December 2029

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Time to first exacerbation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov