Bronchial asthma Respiratory Asthma
Conditions
Interventions
60 subjects randomised into 3 groups (n = 20):
Test Product 1: Alviolife™ 150 mg (75 mg twice daily [bid])
Test Product 2: Alviolife™ 250 mg (125 mg bid)
Test Product 3: Placebo (suitable excipients
Sponsors
Laila Impex R&D Center (India)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must understand the risks and benefits of the protocol 2. Age range of 21 - 60 years having moderate to severe bronchial asthma (male or female, with a diagnosis of asthma for at least one year) 3. Observed symptoms of bronchial asthma (dyspnoea, wheezing, tightness in chest, cough etc.) 4. Subjects with mild to moderate obstruction on PFT with significant bronchio-reversibility 5. Subjects with severe asthma with significant bronchio-reversibility and clinically stable 6. Chest radiograph without evidence of pulmonary disease, other than asthma 7. Forced expiratory volume in 1 second (FEV1) had to be greater than 70% of the predicted value (after withholding ß agonist for greater than 6 hours) at the pre-study visit and to improve by greater than 15% (absolute value) after inhaled ß agonist 8. Ability to provide informed consent, as evidenced by signing a copy of the consent form approved by the Institutional Review Board 9. Moderate asthma is defined as follows (summarised from the National Asthma Education Program Expert Panel Report, USPHS Publication No. 91-304, p. 71-86): moderate asthma is characterised by symptoms poorly regulated by episodic administration of a ß2 agonist. Included in this category is asthma causing frequent symptomatic exacerbations (more than twice a week, at night, or with ordinary activities).
Exclusion criteria
Exclusion criteria: 1. Severe bronchial asthma (peak expiratory flow rate [PEFR] less than 20% and forced expiratory volume in 1 second (FEV1) less than 20% of predicted value) 2. Pregnant and lactating women, subjects having chronic bronchitis and/or emphysema, or subjects suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, cardiovascular disorders or breathlessness due to cardiovascular disorders, hepatic dysfunction, neurological disorders and diarrhoeal disorders 3. Respiratory tract infection and other serious medical illnesses in addition to asthma 4. History of lung disease other than asthma (i.e., chronic obstructive pulmonary disease [COPD], sarcoidosis) 5. History of diabetes mellitus, insulin secreting tumour, or symptomatic hypoglycaemia 6. Human immunodeficiency virus (HIV) or other known immunodeficiency 7. Pre-existing oedema (2-plus or greater) 8. Haemoglobin less than 12 g/dl for males and less than 11 g/dl for females 9. History of liver disease or abnormal liver function tests greater than 2 x upper limit of normal 10. History of drug or alcohol abuse 11. Subjects must be non-smokers of cigarettes, pipes or cigars
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline, day 7, 14, 28 and 56: 1. Symptom score 2. Asthma quality of life questionnaire score 3. Daytime and nocturnal score 4. Symptom free days 5. Rescue medication free days 6. Number of rescue medications inhaled (number of occasions) 7. Adverse events 8. Clinical laboratory abnormalities | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline to endpoint in: 1. Peak expiratory flow (PEF) values 2. FEV1 3. Other serum biomarker indices such as TNFalpha, IL-4, IFNgamma | — |
Countries
India
Outcome results
None listed