â??Efficacy and tolerability of Respicor® in the Treatment of Bronchial Asthma: A Randomized, Double-Blind Placebo Controlled Clinical Studyâ??
- Conditions
- Health Condition 1: null- Asthma
- Registration Number
- CTRI/2016/10/007393
- Lead Sponsor
- aila Impex RnD centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Participants must understand the risks and benefits of the protocol.
Age range of 21 - 60 years having mild to moderate asthma (male or female, with a diagnosis of asthma for at least one year.)
Observed symptoms of bronchial asthma (dyspnoea, wheezing, tightness in chest, cough etc.)
Subjects with mild to moderate obstruction on PFT with significant bronchio reversibility.
Subjects with mild to moderate with significant bronchio reversibility and clinically stable.
Chest radiograph without evidence of pulmonary disease, other than asthma.
Forced expiratory volume in 1 second (FEV1) had to be >70% of the predicted value (after withholding β agonist for >6 hours) at the pre-study visit and to improve by >15% (absolute value) after inhaled β agonist.
Ability to provide informed consent, as evidenced by signing a copy of the consent form approved by the Institutional Review Board.
Moderate asthma is defined as follows(summarized from the National Asthma Education Program Expert Panel Report, USPHS Publication No. 91-304, p. 71-86)
Moderate asthma is characterized by symptoms poorly regulated by episodic administration of a β2 agonist. Included in this category is asthma causing frequent symptomatic exacerbations (more than twice a week, at night, or with ordinary activities).
Severe bronchial asthma (Peak Expiratory flow rate (PEFR) 20% and Forced Expiratory volume in 1 second (FEV1) 20% of predicted value).
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.
Respiratory tract infection and other serious medical illnesses in addition to asthma.
History of lung disease other than asthma (i.e., COPD, sarcoidosis).
History of diabetes mellitus, insulin secreting tumor, or symptomatic hypoglycemia.
HIV or other known immunodeficiency.
Pre existing edema (2-plus or greater).
Hemoglobin less than 12 gm/dl for males and less than 11 gm/dl for females.
History of liver disease or abnormal liver function tests greater than 2 X upper limit of normal.
History of drug or alcohol abuse.
Subjects must be non-smokers of cigarettes, pipes or cigars.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint were: symptom score; asthma quality of life questionnaire score; daytime and nocturnal score; symptom free days; rescue medication free days; number of rescue medication inhaled (number of occasions), adverse events and clinical laboratory abnormalities.Timepoint: Day-0,7,14,28 and 56
- Secondary Outcome Measures
Name Time Method The secondary efficacy endpoint was the mean percent change from Baseline to Endpoint in peak expiratory flow rate(PEFR) values, FEV1 and other serum biomarker indices.Timepoint: Day-0,7,14,28 and 56