Efficacy and tolerability of Alviolife™ in the treatment of bronchial asthma
| ISRCTN | ISRCTN77429857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77429857 |
| Secondary identifying numbers | 09-001/Resp/As |
- Submission date
- 29/04/2009
- Registration date
- 26/03/2010
- Last edited
- 15/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pothina Yugandhar
Scientific
Scientific
Department of Pulmonary Medicine
Alluri Sitarama Raju Academy of Medical Sciences (ASRAM)
Eluru
534004
India
Study information
| Study design | Randomised double blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the details found in the interventions section to request a patient information sheet |
| Scientific title | Efficacy and tolerability of Alviolife™ in the treatment of bronchial asthma: a randomised, double-blind placebo controlled clinical study |
| Study objectives | Alviolife™ is a novel herbal composition. In vitro human mococyte/macrophage cell-based assays demonstrate that Alviolife™ inhibits pro-inflammatory cytokine tumour necrosis factor-alpha (TNF-alpha) and adipocyte/macrophage fatty acid-binding protein aP2 (aP2), a protein which regulates allergic airway inflammation. In addition, Alviolife™ attenuates the TH1/TH2 cytokine imbalance in sephadex induced airway inflammation model of Sprague Dawley rats. Therefore, we hypothesise that this novel herbal composition, Alviolife™ can used as a therapeutic agent in treating human airway inflammatory diseases like asthma. |
| Ethics approval(s) | Institutional Review Board (IRB) of Alluri Sitarama Raju Academy of Medical Sciences (ASRAM) approved on the 2nd February 2009 (ref: # ASRAM IRB # 09-001/Resp/As) |
| Health condition(s) or problem(s) studied | Bronchial asthma |
| Intervention | 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 [yellow dextrin]) Total duration of interventions is 56 days, follow-up evaluations at baseline, day 7, 14, 28 and 56. Contact details for patient information material: Laila Impex R&D Centre Unit-1, Phase-III Jawahar Autonagar Vijayawada 520 007 India |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Alviolife™ |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 12/02/2009 |
| Completion date | 30/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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). |
| Key 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 |
| Date of first enrolment | 12/02/2009 |
| Date of final enrolment | 30/01/2010 |
Locations
Countries of recruitment
- India
Study participating centre
Department of Pulmonary Medicine
Eluru
534004
India
534004
India
Sponsor information
Laila Impex R&D Center (India)
Hospital/treatment centre
Hospital/treatment centre
Unit 1, Phase III
Jawahar Autonagar
Vijayawada
520 007
India
| Website | http://lailaimpex.tradeindia.com |
|---|---|
"ROR" |
https://ror.org/05q6g7072 |
Funders
Funder type
Industry
Laila Impex R&D Center (India)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
