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An Observational Post Marketing study to check the safety and tolerance of Alerfix Total in patients with Asthma

A Phase IV , Randomized, Open Label, multicentre study to confirm the safety and tolerability of Alerfix Total (Levocetirizine, Montelukast, Ambroxol) in patients with Non specific respiratory symptoms (NSRS) with Asthma.

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/09/009643
Enrollment
120
Registered
2017-09-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J459- Other and unspecified asthma Health Condition 2: null- Patients with Cough and/or wheeze and/or chronic dyspnoea with asthma.

Interventions

Intervention1: Tablet Alerfix Total: Montelukast 10 MG+Levocetirizine 5 MG+Ambroxol 75 MG Control Intervention1: Not Applicable: Not Applicable

Sponsors

Eris Life sciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Men or Women, between 18 to 80 years of age (both inclusive). 2. The patient experiencing Cough and/or wheeze and/or chronic dyspnoea or any other symptoms of NSRS with asthma 3. Patient indication and disease condition according to the â??INDICATION & USAGEâ?? as mentioned in the package insert available with Alerfix Total 4. Women of childbearing potential using an acceptable method of birth control. 5. Willing to give written informed consent for participation in the study and to comply with the study procedures

Exclusion criteria

Exclusion criteria: 1. Evidence of active liver disease or SGPT > 2.5 times upper limit of normal (ULN) 2. Evidence of renal impairment (Serum creatinine levels more than 2.0 mg /dl) 3. Pregnancy 4. Malignancy 5. Contraindication as mentioned in package insert 6. Patients with medical conditions that preclude the follow-up as defined in the protocol or otherwise limits participation in this study 7. Patients with known history of hypersensitivity to the study drug

Design outcomes

Primary

MeasureTime frame
To explore the overall safety profile of Alerfix total, as measured by adverse events and Questionnaires, in patients with NSRS and asthma under conditions of routine medical practice.Timepoint: Not Applicable

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactDr Hiren Gandhecha

Accutest Research Laboratories (I) Pvt Ltd

ajay.malle@accutestglobal.com02227780718

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026