A clinical trial to study the effects of two bronchodilators in patients with bronchial asthma.

Evaluation of efficacy and safety of two bronchodilators for the treatment of bronchial asthma: a randomized, open label, active controlled, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001496

Enrollment

200

Registered

2011-01-17

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

None listed

Interventions

Intervention1: IP-033: 1 tablet OD or BD for 14 days Control Intervention1: Salbutamol: 2 to 8 mg three to four times daily for 14 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged between 18 and 65 years. 2. Patients diagnosed with bronchial asthma. 3. Patients willing to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control. 2. Patients with suspected hypersensitivity and/or contraindication to the study medication or rescue medications. 3. Patients suffering from lung disease other than asthma. 4. Patients with history of non-compliance to medical regimens or those patients unwilling to comply with the study protocol. 5. Patients with any severe illness like liver insufficiency, active hepatitis, known infection with HIV etc. 6. Patients who have been hospitalized for asthma within three month before the study. 7. Patients having any musculoskeletal, cardiovascular, or neurological condition or any other condition likely to adversely affect exercise performance or measurement of lung function. 8. Patients having disease like hyperthyroidism, heart disease and diabetes mellitus.

Design outcomes

Primary

Measure	Time frame
Average change from baseline to end of trial in Forced expiratory volume in one second (FEV1)Timepoint: Day 0, Day 14	—

Secondary

Measure	Time frame
1.Evaluation of auscultatory pattern. 2. Average change from baseline to end of study in Symptom score (with an ordinal rating scale) of ? Cough ? Difficulty in expectorating ? Dyspnoea ? Cyanosis 3.Evaluation of Expectoration characteristic score ? Viscosity of sputum ? Characteristic of sputum 4.Evaluation CGI-S 5.Evaluation CGI-I 6.Evaluation of Rescue medicines taken. Timepoint: 1. Day 0, Day 14 2. Day 0, Day 14 3. Day 0, Day 14 4. Day 0, Day 14 5. Day 14 6. Day 14	—

Measure

Time frame

1.Evaluation of auscultatory pattern. 2. Average change from baseline to end of study in Symptom score (with an ordinal rating scale) of ? Cough ? Difficulty in expectorating ? Dyspnoea ? Cyanosis 3.Evaluation of Expectoration characteristic score ? Viscosity of sputum ? Characteristic of sputum 4.Evaluation CGI-S 5.Evaluation CGI-I 6.Evaluation of Rescue medicines taken. Timepoint: 1. Day 0, Day 14 2. Day 0, Day 14 3. Day 0, Day 14 4. Day 0, Day 14 5. Day 14 6. Day 14

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Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results