Phase 3 Asthma Trial, Recruiting NCT06429475 Sponsor: University of KwaZulu Condition: Asthma
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Phase 3 Asthma Trial, Recruiting

NCT06429475
Recruiting Phase 3

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:

  • You are between 6 and 18 years old at the time of signing up for the study
  • You have already been diagnosed with asthma and are currently on treatment for it
  • You have recently been diagnosed with asthma for the first time
  • Your asthma diagnosis has been confirmed through breathing tests (either a spirometry test showing improvement after using an inhaler, or peak flow measurements taken twice a day over 2 weeks)
  • You are able to perform a peak flow breathing test and/or a breathing test that checks how your lungs respond to an inhaler
  • You have mild or moderate asthma based on your medical history
  • You have had at least one asthma flare-up in the past year that needed steroid tablets/medicine for 3 or more days, and/or a hospital or emergency room visit where you received steroid treatment
  • You (or your parent/guardian) are able to give written consent to take part, and you agree to take part yourself where appropriate
  • You and/or your parent/guardian are willing to follow the study procedures, attend required visits, and be available for phone calls during remote check-ins

Who may not be able to join:

  • You have active tuberculosis (TB), or you have been in close contact with someone who has active TB in the last 6 months
  • You have had ongoing coughing up of mucus, chest pain, shortness of breath, dizziness, or light-headedness in the last 2 months
  • You have a heart rhythm problem (irregular heartbeat)
  • You have certain long-term health conditions, including an overactive thyroid, a type of adrenal gland tumour (phaeochromocytoma), heart or blood vessel disease, or severely high blood pressure (confirm with trial site)
  • You have diabetes that is not well controlled
  • Your peak flow breathing test result is less than 50% of what would be expected for someone your age and size, as this would suggest severe asthma
  • You have a history of a very serious, life-threatening asthma attack that required a breathing tube, or caused you to stop breathing, have seizures due to low oxygen, or lose consciousness
  • You are currently using advanced asthma treatments such as biologic injections, methotrexate, or regular steroid tablets taken by mouth (confirm with trial site)
  • You have a medical or surgical condition that could affect how the study medicine moves through your body in a way that might put you at risk (confirm with trial site)
  • You have any physical, mental, or social condition, or abnormal test results, that the study doctor believes could put you at risk or make it difficult for you to complete the study
  • You are unable to attend follow-up visits, or you are planning to move away from the study area within 12 months of joining

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 19 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Limakatso Lebina, PhD, Africa Health Research Institute

Phone: 800-555-5555

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
University of KwaZulu
Registry
ClinicalTrials.gov
Start date
6 June 2024
Est. completion
31 December 2028

Where this trial is recruiting

🇿🇦 South Africa

Primary endpoints

Number of exacerbations in 52 weeks ( End of study)

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: 19 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