A Randomized, double-blind, crossover, non-inferiority study comparing bronchodilator effects of single dose of 18 mcgg of Tiotropium Bromide and two doses of 12 mcg of Formoterol Fumarate each over 24 hours in subjects with moderate to severe asthma.

Chest Research Foundation0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Asthma diagnosed according to GINA guidelines
•Airway reversibility ? increase of at least 12% from baseline and 200ml ? to inhaled combination of both salbutamol 20mcg and ipratopim bromide 80 mcg delivered through a pMDI with Spacer within 30 min.
•FEV1 40-80% of the predicted normal
•Age 18 to 70 years males or females
•No asthma exacerbation during past one month
•On a stable dose of inhaled ICS for past 1 month
•Smoking history < 10 pack years
•Written informed consent
•Female subjects who are not menopausal must be willing to and actually use contraceptives method of proven efficacy.

•Unable to discontinue long-acting bronchodilators including theophylline for 24 hours and short acting bronchodilators for 6 hours prior to onset on the study day.
•Radiological or clinical evidence of other pulmonary diseases
•Subjects with the clinical evidence of heart failure or arrhythmias.
•Concurrent diseases likely to affect the study e.g. tuberculosis, bronchogenic carcinoma, pneumonia, ischaemic heart disease, liver disease.
•Subjects with COPD
•Subjects with history of asthma exacerbation in past 4 weeks
•Subjects who have taken oral corticosteroids in the previous 4 weeks, or who are taking them currently.
•Uncooperative subjects or subjects unable to perform lung functions.
•Participation in other clinical studies during the month prior to visit 1.
•Subjects too ill as judged by the investigators to participate.
•Subjects with abnormal laboratory or biochemical values (abnormal liver function tests, abnormal kidney functions and abnormal basal sugar levels).
•Pregnant and lactating women.
•Subjects with known hypersensitivity to anticholinergic drugs and beta2 adrenergic agonists, known symptomatic prostatic hypertrophy or narrow angle glaucoma.

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