A clinical trial comparing bronchodilator effects of two drugs,Tiotropium Bromide and Formoterol Fumarate each over 24 hours in subjects with Asthma.
- Conditions
- Health Condition 1: null- asthma
- Registration Number
- CTRI/2008/091/000306
- Lead Sponsor
- Chest Research Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in FEV1 values from baseline as measured by area under the curve over a period of 24 hoursTimepoint: 24 hours
- Secondary Outcome Measures
Name Time Method 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