Health Condition 1: null- asthma
Conditions
Interventions
Intervention1: Tiotropium Bromide: 18mcg once daily
Control Intervention1: Formoterol Fumarate: 12 mcg bd
Control Intervention2: placebo: 1 rotacap bd
Sponsors
Chest Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 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 Written informed consent Female subjects who are not menopausal must be willing to and actually use contraceptives method of proven efficacy.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FEV1 values from baseline as measured by area under the curve over a period of 24 hoursTimepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean difference in maximum FEV1, FVC Time of onset of response, Time to maximum response, Duration of response for each treatment arm, Trough FEV1 and FVC valuesTimepoint: Over a period of 24 hours | — |
Countries
India
Contacts
Public ContactDr Sneha Limaye
Research Associate
Outcome results
None listed