A clinical trial to study the effects of two drugs, sustained release and immediate release mucoregulator in patients with bronchial asthma.

Evaluation of Efficacy and Safety of a Sustained release vs. Immediate release Mucoregulator for the treatment of bronchial asthma: An open label, randomized, comparative, multi-centric trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000571

Enrollment

200

Registered

2010-06-01

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: Sustained Release Mucoregulator: The recommended dose is one tablets OD for 14 days Control Intervention1: Immediate Release Mucoregulator: The recommended dose is one capsule BD for 14

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female Patients aged between 18 and 65 years. 2. Patients with history of bronchial asthma and chronic obstructive pulmonary disease as defined by American Thoracic Society (ATS). 3. Baseline FEV1 50 ? 85% in patients either untreated or receiving e.g. short-acting bronchodilators. 4. No change in the asthma treatment 4 weeks prior to baseline period 5. Patients willing to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women and women of childbearing potential who are not using contraceptives. 2. Patients with infection of lower airways. 3. Patients with cancer, pulmonary tuberculosis, or acute infection, Myocardial infarction, low blood pressure. 4. Patients who were hospitalized for asthma within three month before the study. 5. Patients suffering from lung disease other than asthma and COPD. 6. Patients who had used systemic steroid prior to 4 week of baseline visit and who are taking long acting &#946;-agonist, inhaled anticholinergics with in one month before study and cromolyn, nedocromil within two week before study. 7. Patients who were heavy smokers with > 10 pack-years. 8. Patients with any severe illness like liver insufficiency, active hepatitis, known infection with HIV etc. 9. Patients with history of non-compliance to medical regimens or those patients unwilling to comply with the study protocol. 10. Patients with suspected hypersensitivity and/or contraindication to any ingredients of the study medication or rescue medications.

Design outcomes

Primary

Measure	Time frame
Average change from baseline to end of trial in Forced expiratory volume in one second(FEV1).Timepoint: Baseline Visit (day 0), week 2.	—

Secondary

Measure	Time frame
1. Average change from baseline to end of trial in Forced expiratory vital capacity.(FVC) 2. Evaluation of auscultatory pattern 3. Average change from baseline to end of study in Symptom score (with an ordinal rating scale) of ? Cough ? Difficulty in expectorating ? Dyspnea ? Cyanosis 4. Expectoration characteristic score ? Viscosity of sputum ? Characteristic of sputum 5. Evaluation CGI-S and CGI-I Timepoint: 1. Baseline Visit (day 0), week 2. 2. For CGI-I, at week 2 only.	—

Measure

Time frame

1. Average change from baseline to end of trial in Forced expiratory vital capacity.(FVC) 2. Evaluation of auscultatory pattern 3. Average change from baseline to end of study in Symptom score (with an ordinal rating scale) of ? Cough ? Difficulty in expectorating ? Dyspnea ? Cyanosis 4. Expectoration characteristic score ? Viscosity of sputum ? Characteristic of sputum 5. Evaluation CGI-S and CGI-I Timepoint: 1. Baseline Visit (day 0), week 2. 2. For CGI-I, at week 2 only.

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Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results