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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT01720069
Eligibility Criteria:
Inclusion:
* Written informed consent
* Adolescents aged 12-17 years \& adults aged 18-65 years (both inclusive)
* Documented clinical history of severe asthma requiring prednisone/prednisolone therapy, high-intensity treatment ICS, OCS, LABA
* Stable OCS dose for ≥7 days before Screening Visit \& during Screening Period.
* At least 80% compliant w/regular asthma medication per investigator at end of Screening Period
* Documented asthma reversibility within 5 yrs prior to/during Screening Period, or diagnosis of asthma that is incontrovertible per investigator
* Ability to use nDPI correctly, per investigator's review of completed inhaler operation checklist
* Ability to use eDiary correctly, assessed by investigator at end of Screening Period
* Ability to comply w/study procedures, including blood sampling
* Ability to perform technically satisfactory pulmonary function tests
* Available to complete all study visits before 12 noon
* BMI of 16-26 kg/m2 in adolescents and 18-32 kg/m2 in adults
* Oral PIF ≥40 L/min, using an appropriate device set to match resistance of inhaler
* Good health, except for presence of asthma, per medical history/physical examination
* Negative drug/alcohol/urine cotinine screen. Subjects must test negative for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, cotinine, ethanol \& opiates (unless given as prescription medicine)
* Non-smokers or ex-smokers with a smoking history of less than 10 pack-yrs (e.g. \<20 cigarettes per day for 10 years or \<40 cigarettes per day for 5 years) \& stopped smoking for at least 1 year prior to Screening Visit. Smoking will not be permitted throughout study
* Female subjects of child-bearing potential must be using medically acceptable forms of contraception \[abstinence, hormonal (oral/implant/transdermal/injection), in use for ≥3 consecutive months before first dose of study medication, double barrier (condom w/spermicide, or diaphragm w/spermicide), IUD, or vasectomised partner (≥6 months since vasectomy)\].
Exclusion:
* Regular use (≥3 times/wk) of topical steroids to treat dermatitis/rhinitis/allergic conjunctivitis, within 28 days of Screening Visit
* Subjects who have/who have had, an upper/lower respiratory tract infection within 28 days of Screening Visit
* Subjects w/"brittle asthma
* Subjects w/asthma that required admission to an ICU and/or ventilation within previous 12 months
* Subjects whose comorbidities, per investigator's opinion, are major contributors to their respiratory symptoms (e.g. COPD, bronchiectasis, dysfunctional breathlessness, vocal cord dysfunction, gastro-oesophageal reflux)
* Previously/currently diagnosed as having Churg-Strauss syndrome
* Previously/currently diagnosed as having pulmonary eosinophilia
* History of lung cancer
* Subjects w/current diagnosis of HIV infection
* Active chronic hepatitis B or C infection
* Subjects who have clinically significant abnormality/finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment
* Subjects with an abnormal ECG
* Persistent arterial hypotension, with average SBP readings of ≤95 mmHg
* Persistent elevation of blood pressure, with average SBP readings of ≥160 mmHg or average DBP readings of ≥100 mmHg
* Pregnant or lactating females
* Participation in another clinical study in 28 days prior to Screening Visit
* Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrectable hypokalaemia, or predisposition to low levels of serum potassium
* Current/history of drug/alcohol abuse/dependence per WHO criteria
* Inability to communicate well w/investigator
* Donation of ≥450 mL of blood/blood products within previous 3 months prior to screening
* History of allergy/intolerance/contraindications to corticosteroids/lactose, or severe allergy to milk proteins
* Consumption of alcohol- or caffeine-containing foods/beverages from midnight before or during Screening Visit
* History of medically diagnosed chronic respiratory diseases other than asthma (e.g. chronic obstructive pulmonary disease, ABPA in the absence of asthma)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT01720069
Study Brief:
Protocol Section:
NCT01720069