Phase 2 Asthma Trial, Recruiting NCT07326995 Sponsor: Anhui Palo Alto Pharmaceuticals, Inc. Condition: Asthma
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Phase 2 Asthma Trial, Recruiting

NCT07326995
Recruiting Phase 2

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 aged 18 to 75 years, of any gender
  • People who have been diagnosed with bronchial asthma according to Chinese clinical guidelines — including those newly diagnosed, or those diagnosed with asthma during childhood or adolescence whose symptoms have become noticeably worse in adulthood
  • People whose breathing test results before the trial show lung function within a specific moderate range (FEV1 between 60% and 85% of the expected value for their age and size)
  • People whose breathing tests show variable airflow limitation — confirmed by at least one of several possible tests, such as a bronchodilator response test, a bronchial challenge test, or peak flow monitoring over 7 days (confirm with trial site for which test applies)
  • People who have voluntarily signed a consent form agreeing to take part

Who may not be able to join:

  • People who are unable to correctly use a nebuliser (inhaled mist device), cannot tolerate this type of medication delivery, or do not pass inhaler training
  • People who have other lung conditions such as chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, or tuberculosis — where, in the investigator's judgement, asthma is still the main condition (confirm with trial site)
  • People with other significant conditions that affect lung function, such as diseases of the pleura, chest wall, diaphragm, or certain muscle conditions
  • People with a history of serious heart conditions — such as heart failure, coronary artery disease, heart attack, irregular heartbeat, or uncontrolled high blood pressure — where the investigator judges this would pose a risk or affect the results
  • People with an overactive thyroid (hyperthyroidism) that the investigator considers unsuitable for trial participation
  • People with a history of serious blood, liver, psychiatric, kidney, or other diseases that the investigator believes would pose a risk or affect the results
  • People who have had a cancer diagnosis in the past five years (exceptions may apply for certain treated cancers — confirm with trial site)
  • People who have had, or are expected to have, a solid organ or bone marrow transplant within the coming year
  • People with low potassium levels in their blood at the time of screening
  • People with Type 1 diabetes, or Type 2 diabetes that is not well controlled (based on a fasting blood sugar test at screening)
  • People found to have a fungal infection of the mouth, throat, or food pipe (candidiasis) at or before the start of the trial
  • People with abnormal liver or kidney function based on blood tests at screening
  • People with certain active or significant hepatitis B or C infections, a positive HIV test, or a history of AIDS
  • People with a known allergy to inhaled corticosteroids or to salbutamol (a common reliever medication)
  • People who have had a respiratory infection, sinus infection, or middle ear infection within 4 weeks before screening or during the run-in period, where the investigator believes this affected their asthma treatment or condition
  • People who had an asthma flare-up requiring steroid tablets or injections within 4 weeks before screening or during the run-in period, or who require ongoing oral steroid treatment for asthma
  • People who have taken certain strong medications that affect how the body processes drugs (strong CYP3A4 inhibitors, such as ritonavir or ketoconazole) within 4 weeks before starting the trial, or who would need to take these during the trial
  • People who stopped smoking less than 1 year before screening, or who have a smoking history of more than 10 pack-years — this includes cigarettes, cigars, pipe tobacco, and e-cigarettes
  • People with a history of drug, substance, or alcohol misuse within the 2 years before screening (alcohol misuse is defined as more than 2 standard units per day on average)
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
  • People who have taken part in another clinical trial within 1 month before screening
  • Anyone else the investigator considers unsuitable for any other reason

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 16 July 2026
Phase 2: approximately ~30% 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: Wei Zuo, The First Affiliated Hospital of Nanchang University

Phone: 86-15618775927

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 2
Sponsor
Anhui Palo Alto Pharmaceuticals, Inc.
Registry
ClinicalTrials.gov
Start date
24 February 2025
Est. completion
1 February 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Evaluation the change in morning pre-dose forced expiratory volume in one second (FEV1) from baseline to week 4 of treatment.

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: 16 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