Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
NCT ID:
NCT04206761
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be directly obtained from legally competent participants before any study- related assessment is performed.
* Male and female adult participant ≥ 18 years of age and ≤ 80 years of age.
* Participants with a confirmed clinical diagnosis of asthma by a respirologist for a period of at least 6 months prior to Visit 101.
* Participants who demonstrate reversibility in FEV1 by one of :
1. Increase in forced expiratory volume in one second (FEV1) of ≥ 12% and 200 ml 15 to 30 minutes after administration of 400μg salbutamol at Visit 101
2. Documented increase in FEV1 of ≥ 12% and 200 ml 15 to 30 minutes after administration of 400μg salbutamol in past 24 months
3. Documented increase in FEV1 of ≥ 12% and 200 ml after treatment for asthma (e.g. treatment with ICS) in past 24 months
4. Documented positive methacholine challenge in past 24 months
* Participants who have used high dose dual therapy (ICS/LABA) for asthma for at least 3 months and at a stable dose equivalent to high dose ICS for at least 1 month prior to Visit 101 (please refer to Table 1-1 for ICS dosages).
* Participants with visually obvious MRI ventilation defects at Visit 102.
* Pre-bronchodilator FEV1 of \< 85% of the predicted normal value for the participant after withholding bronchodilators prior to spirometry at Visit 101.
Exclusion Criteria:
* Participants meeting contraindications for undergoing an MRI such as participants with MRI-sensitive implants, tattoos with MRI-sensitive dye and severe claustrophobia.
* Currently smoking or vaping any substance (e.g. nicotine, cannabis) at Visit 101 or within 12 months of visit 101.
* Ex-smoker of nicotine or cannabis with a smoking history of ≥ 10 pack years or 20 joint years (Note: 1 pack is equivalent to 20 cigarettes. 10 pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs. 1 joint year is equivalent to 1 joint/day x 1 year)
* Participants diagnosed with Chronic Obstructive Pulmonary Disease (COPD). Diagnoses of asthma- COPD overlap syndrome may be eligible.
* Participants who have had an asthma attack/exacerbation requiring systemic steroids, hospitalization and/or emergency room visit within 6 weeks of Visit 101 or a respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 101. If participants experience an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit between Visit 101 and Visit 201, they will be withdrawn from the study but may be re-screened 4 weeks after recovery from the exacerbation.
* Participants treated with a LAMA for asthma within 3 months prior to Visit 101.
* Participants with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder- neck obstruction or severe renal impairment or urinary retention. BPH participants who are stable on treatment can be considered.
* Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
* Use of other investigational drugs within 30 days (e.g. small molecules) / or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer.
* History of hypersensitivity to any of the study treatments or its excipients or to other drugs of similar chemical classes.
* Participants with paroxysmal (e.g., intermittent) atrial fibrillation are excluded. Participants with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., selective beta blockers, calcium channel blocker, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such participants, atrial fibrillation must be present at Visit 101 with a resting ventricular rate \< 100/min.
* Participants with a history of myocardial infarction within 12 months prior to Visit 101.
* Concomitant use of agents known to prolong the QT interval unless it can be discontinued for the duration of study. Decisions about the discontinuation of such agents will be made between the Qualified Investigator and participant.
* Participants with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (\> 450 msec for males and \> 460 msec for females). These participants may not be rescreened.
* Participants with a history of lactose intolerance and hypersensitivity to any of the study drugs or its excipients, or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and follow-up period. Highly effective contraception methods include:
1. True sexual abstinence with male partner(s) (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
2. Female sterilization (have had surgical tubal ligation, bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
3. Vasectomized male partner(s) (at least 6 months prior to Visit 101).
4. Use hormonal contraception with failure rate \<1% (e.g. oral contraceptive pill, Depo-Provera™ injections, Erva Patch™ or Nuvaring™).
5. Placement of an MRI safe intrauterine device (IUD) or intrauterine system (IUS).
In case of use of hormonal contraception, women should have been stable on the same pharmacological agent for a minimum of 3 months before Visit 101. Women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04206761
Study Brief:
Protocol Section:
NCT04206761