Phase 3 Asthma Trial, Recruiting NCT07546981 Sponsor: Chiesi Farmaceutici S.p.A. Condition: Asthma
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Phase 3 Asthma Trial, Recruiting

NCT07546981
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:

  • People who are willing and able to provide written consent before any study procedures begin
  • People who are Chinese, male or female, and between 18 and 75 years of age
  • People who have a documented asthma diagnosis of at least 1 year, and whose asthma was first diagnosed before the age of 40
  • People whose asthma is not well controlled and who have been taking a combination of two inhaled medications — a medium-dose inhaled corticosteroid (ICS) and a long-acting bronchodilator (LABA) — at a stable dose for at least 4 weeks before the screening visit
  • People whose lung function test (measuring how much air can be exhaled) shows a result below 80% of the expected normal value, after stopping certain inhalers for a set period before the screening visit
  • People whose lungs show a meaningful improvement in airflow after using a bronchodilator during the screening test
  • People whose asthma symptoms score 1.5 or higher on a standard asthma control questionnaire (ACQ-7), measured at both the screening visit and at the point of being assigned to a treatment group

Who may not be able to join:

  • People with a history of life-threatening asthma attacks, or past hospital admission for a very severe asthma episode, where the trial doctor judges this may pose an unacceptable risk
  • People who have been hospitalised, visited an emergency room, or taken oral or injectable steroid medications for an asthma flare-up in the 4 weeks before screening or during the lead-in period
  • People who have had any asthma flare-up or respiratory tract infection in the 4 weeks before screening or during the lead-in period
  • People whose ICS and LABA combination medication had a change in dose, schedule, or formulation in the 4 weeks before screening
  • People who have taken oral or injected steroid medications in the 4 weeks before screening, or slow-release steroid medications in the 12 weeks before screening
  • People with a diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, or any other significant lung condition that may affect the study results
  • People who currently smoke, who are ex-smokers with a total smoking history of 10 pack-years or more, or who stopped smoking within 1 year before the screening visit
  • People who are currently being treated with monoclonal antibody therapies or biological drugs (for example, anti-IgE or anti-IgG treatments)
  • People who have taken an experimental drug within 2 months or six half-lives (whichever is longer) before screening, who have previously been enrolled in this study, or who are currently taking part in another clinical trial

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 12 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: Chen Wang Academician, Principal Investigator, China-Japan Friendship Hospital

Phone: + 39 0521 2791

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
Chiesi Farmaceutici S.p.A.
Registry
ClinicalTrials.gov
Start date
26 June 2026
Est. completion
17 October 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Peak FEV1

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: 12 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