This is a research study to check how safe and effective is Theoasthalin/ Theoasthalin forte tablets in patients with asthma and other chronic lung diseases.

An open label, observational, practice based, non-comparative, multicenter, prospective, active surveillance to evaluate the safety and efficacy of theoasthalin/theoasthalin forte tablet in patients with reversible airflow obstruction associated with asthma and other chronic lung diseases

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2020/01/023000

Enrollment

200

Registered

2020-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: J00-J99- Diseases of the respiratory system

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. A written, signed, dated and ethics committee approved informed consent form (data sharing consent) from Patients and/or legally acceptable representatives 2. Either male or female of age between 18 years and 60 years 3. Patients with reversible airflow obstruction associated with asthma and other chronic lung diseases suitable to receive either theoasthalin/theoasthalin forte tablets.

Exclusion criteria

Exclusion criteria: 1. Patients with hypersensitivity to study drugs. 2. Patients with pregnancy or lactation. 3. Patients with Active peptic ulcer disease. 4. Patients with Seizure disorders. 5. Patients with Cardiac arrhythmias. 6. Concurrent diseases such as Acute pulmonary edema, Congestive heart failure, Cor pulmonale, Fever; Ã¢â?°Â¥102 F for 24 hours or more; or lesser temperature elevations for longer periods, Hypothyroidism, Hyperthyroidism, Liver disease; cirrhosis, acute hepatitis, Sepsis with multi-organ failure, shock. 7. Patients on beta-blocking drugs. 8. Patients unsuitable for study as per InvestigatorÃ¢â?¬•s discretion. 9. Participated in clinical trial 30 days prior to screening.

Design outcomes

Primary

Measure	Time frame
Safety endpoint: Adverse Events (Serious/Non-serious, Expected/Unexpected, Related/Not Related) Efficacy endpoint: Change in Asthma Control Questionnaire (ACQ) at day 7 and 14 from baseline.Timepoint: Day 7 and 14 from baseline.	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Ltd.

Sandesh.Sawant3@Cipla.com02223025188

Outcome results