Condition category
Respiratory
Date applied
29/04/2009
Date assigned
26/03/2010
Last edited
15/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pothina Yugandhar

ORCID ID

Contact details

Department of Pulmonary Medicine
Alluri Sitarama Raju Academy of Medical Sciences (ASRAM)
Eluru
534004
India

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09-001/Resp/As

Study information

Scientific title

Efficacy and tolerability of Alviolife™ in the treatment of bronchial asthma: a randomised, double-blind placebo controlled clinical study

Acronym

Study hypothesis

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

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)

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the details found in the interventions section to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Alviolife™

Primary outcome measures

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 trial start date

12/02/2009

Overall trial end date

30/01/2010

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

12/02/2009

Recruitment end date

30/01/2010

Locations

Countries of recruitment

India

Trial participating centre

Department of Pulmonary Medicine
Eluru
534004
India

Sponsor information

Organisation

Laila Impex R&D Center (India)

Sponsor details

Unit 1
Phase III
Jawahar Autonagar
Vijayawada
520 007
India

Sponsor type

Hospital/treatment centre

Website

http://lailaimpex.tradeindia.com

Funders

Funder type

Industry

Funder name

Laila Impex R&D Center (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes