Asthma Trial, Recruiting NCT04912596 Sponsor: Intech Biopharm Ltd. Condition: Asthma
Back to Asthma

Asthma Trial, Recruiting

NCT04912596
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:

  • You are a man, or a woman who is not pregnant or breastfeeding, between 20 and 65 years old.
  • You have been officially diagnosed with mild asthma, according to recognised asthma guidelines.
  • Your asthma has been stable for at least 1 month, and you are using a low-dose inhaled steroid (with or without a reliever inhaler) on a regular basis.
  • A breathing test shows your lungs are working at 80% or more of the expected level for someone your age and size (after not using your reliever inhaler for at least 8 hours).
  • A special airway sensitivity test (using a substance called methacholine) shows your airways are reactive at a certain level (confirm with trial site).
  • You have not smoked for at least 6 months, and your total smoking history is no more than the equivalent of one pack per day for 5 years.
  • You are willing and able to sign a consent form agreeing to take part.
  • Apart from asthma, you are generally in good health.
  • Your body mass index (BMI — a measure of weight relative to height) is between 17 and 35.
  • You are able to use a standard metered-dose inhaler (a pressurised puffer inhaler) correctly.
  • You are able to do breathing tests properly and consistently, without the effort of blowing causing your airways to tighten.
  • If you or your partner could become pregnant, you agree to use an accepted form of contraception throughout the study (such as sterilisation, hormonal contraception, an IUD, condoms with spermicide, or a diaphragm with spermicide).

Who may not be able to join:

  • You have had a respiratory infection (such as pneumonia, viral bronchitis, sinusitis, or allergic rhinitis) in the 6 weeks before screening.
  • Your breathing test results are below a certain level — specifically, your lung function is below 60% of what is expected, or the volume measured is less than 1.5 litres.
  • You have a history of asthma attacks that happen only at certain times of year due to seasonal allergies (confirm with trial site regarding timing).
  • You have a history of other serious lung conditions such as cystic fibrosis, COPD, emphysema, tuberculosis, lung cancer, pulmonary fibrosis, or pulmonary hypertension.
  • You have a history of heart disease, blood disorders, kidney problems, nerve or brain conditions, liver disease, psychiatric conditions, or hormonal disorders, including certain heart rhythm or electrical abnormalities.
  • You were treated in an emergency room or hospitalised for asthma in the 3 months before screening.
  • You are allergic or sensitive to any ingredient in the study inhalers or to methacholine.
  • You have needed to take steroid tablets or liquid every day in the 3 months before screening.
  • You have an abnormal heart rhythm or abnormal heart electrical readings, or specific measurements from a heart tracing (ECG) that are above certain limits.
  • You are currently taking, or may need to take, a type of medication called a beta blocker (used for heart or blood pressure conditions).
  • You have a history of a certain type of glaucoma (narrow angle), seizures, an overactive thyroid, uncontrolled diabetes, or a condition where inhalers cause airways to tighten instead of opening.
  • You have a history of any cancer.
  • You have a history of alcohol or drug misuse.
  • You have had surgery on your eyes, brain, chest, or abdomen in the 3 months before screening.
  • You have used certain asthma medicines (including cromoglicate, leukotriene blockers, theophylline, or long-acting relievers) in the month before screening.
  • You have used certain other asthma treatments, including specific biological medicines or high-dose inhaled steroids, in the 6 months before screening (confirm with trial site for full list).
  • You are known to be HIV-positive.
  • You have taken part in another clinical trial in the month before screening.
  • You are pregnant or breastfeeding.

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
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

Principal Investigator: Pai-Chien Chou, MD, PhD, Taipei Medical University Hospital

Phone: +886-2-7721-8877

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
Not Applicable
Sponsor
Intech Biopharm Ltd.
Registry
ClinicalTrials.gov
Start date
15 August 2022
Est. completion
31 January 2025

Where this trial is recruiting

🇮🇳 India 🇹🇼 Taiwan

Primary endpoints

Post-dose PC20 Concentration

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