Phase 2 Asthma Trial, Recruiting NCT07301736 Sponsor: Chiesi Farmaceutici S.p.A. Condition: Asthma
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Phase 2 Asthma Trial, Recruiting

NCT07301736
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:

  • You are between 18 and 75 years old (inclusive)
  • You have been diagnosed with asthma for at least 6 months before the screening visit, and your asthma was first diagnosed before you turned 50
  • You are a non-smoker or a former smoker
  • Your body weight is in a healthy range relative to your height — specifically, your BMI (body mass index) is between 18.0 and 35.0 (confirm with trial site)
  • You have been on a stable, low or medium dose asthma inhaler treatment (either a steroid inhaler alone, or a steroid inhaler combined with a long-acting reliever) for at least 4 weeks before screening
  • Your asthma is considered controlled or only partly controlled, based on a short questionnaire score below 1.5 at both the screening and start-of-trial visits
  • Your lung function (measured by a breathing test) falls within a specific range — not too low and not too high — after stopping certain inhalers for a set period before the test (confirm with trial site)
  • Your lungs show a meaningful improvement in a breathing test within 30 minutes of taking a standard reliever inhaler (salbutamol/albuterol) at the screening visit

Who may not be able to join:

  • You have had a life-threatening asthma attack, or been admitted to hospital or an emergency room for asthma in the past 6 months
  • You have needed steroid tablets or injections for an asthma flare-up, or visited an emergency room or been hospitalised for asthma within the past 3 months or during the trial run-in period
  • Your asthma only occurs with exercise or during certain seasons, and you do not need daily asthma medication
  • You are currently taking high-dose steroid inhalers
  • You are currently taking a type of inhaled medication called a long-acting muscarinic antagonist (LAMA) (confirm with trial site)
  • You have taken steroid injections or slow-release steroid medications within the past 12 weeks
  • You have taken certain other asthma medications (such as leukotriene modifiers) within the past 4 weeks (confirm with trial site)
  • You have received any biologic (injectable) asthma therapy (such as omalizumab or dupilumab) within the past 6 months
  • You have a lung or breathing condition other than asthma
  • You have had part of a lung surgically removed
  • You currently have a lower respiratory tract infection (such as a chest infection)
  • You have lung cancer, or have had lung cancer in the past
  • You have or have had any other type of cancer
  • You have a significant heart or cardiovascular condition (confirm with trial site)
  • During the lead-in period before the trial starts, you completed less than 75% of your diary entries or took less than 75% of your required trial medication

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 8 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: Piotr KUNA, MD, Barlicki University Hospital Medical University of Lodz, Poland

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 2
Sponsor
Chiesi Farmaceutici S.p.A.
Registry
ClinicalTrials.gov
Start date
17 December 2025
Est. completion
3 June 2027

Where this trial is recruiting

🇦🇷 Argentina Bosnia and Herzegovina 🇧🇬 Bulgaria 🇨🇿 Czechia 🇩🇪 Germany 🇭🇺 Hungary 🇱🇻 Latvia 🇲🇽 Mexico 🇷🇴 Romania 🇷🇸 Serbia 🇸🇰 Slovakia 🇿🇦 South Africa 🇺🇦 Ukraine 🇬🇧 United Kingdom

Primary endpoints

Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from time zero to 4 hours (AUC0-4h) on Day 1; Change from baseline in pre-dose FEV1 on Day 28

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: 8 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