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 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT01641692
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Outpatient (sub-group will have 3 overnight stays at clinic)
* Diagnosis of asthma (NIH 2007) for at least 6 months
* Male or Eligible female (females of child-bearing potential must use acceptable method of birth control)
* A best AM pre-bronchodilator FEV1 of 60% to 85% of predicted normal value at Screening
* Reversibility of disease demonstrated by at least 12% and 200mL increase in FEV1 .
* Subjects must have been prescribed a non-corticosteroid controller at least 3 months preceding Visit 1, and/or a short-acting beta 2 agonist, without the use of inhaled corticosteroids in the 4 weeks prior to Visit 1
* Subjects must be able to replace their current short-acting Beta-2-agonist with albuterol/salbutamol aerosol inhaler for the duration of the study
* Subjects must be judged capable of withholding albuterol/salbutamol for at least 4 hours prior to study visits
Exclusion Criteria:
* History of life threatening asthma
* Severe asthma exacerbation
* Respiratory infection within expected to affect subject's ability to participate
* Concurrent respiratory disease
* Current smoker or smoking history of 10 pack years or more
* Diseases preventing use of anticholinergics
* Other clinically significant, uncontrolled condition or disease which would pose a safety risk to the patient, or confound interpretation of study results
* Drug allergy to any Beta-2-agonist, sympathomimetic drug, intranasal, inhaled or systemic corticosteroid therapy
* Known or suspected sensitivity to the constituents of the Novel DPI (ie lactose)
* History of severe milk protein allergy
* Administration of prescription or over-the-counter medication that would significantly affect the course of asthma, or interact with the study drug
* Any infirmity, disability or disease of a child or family member likely to impair compliance
* Alcohol or substance abuse history
* Viral hepatitis B surface antigen or Hepatitis C antibody
* Known HIV-positive history.
* Affiliation with investigator or site staff
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01641692
Study Brief:
Protocol Section:
NCT01641692