Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Intervention1: Ambronac Tablet: Each tablet containing N-Acetyl L-Cysteine â?? 200 mg and Ambroxol Hydrochloride â?? 30 mg: Single Arm Post Marketing Study to Evaluate Safety and Efficacy of Ambrona
Sponsors
Tablets India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patients > 18 years and 2.PEFR (Peak Expiratory Flow Rate) more than 250 liters/min. 3.Patients with excess mucus production 4.Patients who usually bring up phlegm from chest first thing in the morning 5. Patients who usually bring up phlegm from chest during the day or night 6. Patients whose chest sound wheezy or whistling on most days (or nights) 7.No allergies to any of the ingredients of the study drug 8.Patient willing to sign informed consent and are willing to follow the protocols requirements
Exclusion criteria
Exclusion criteria: 1.Patient with known hypersensitivity to individual ingredients of tablet 2.Patients below the age of 18 years or above the age of 65 years 3.Patients who is not willing to participate in the study 4.Patients is being treated for bronchitis of any type 5.Patients on corticosteroids, nonsteroidal anti-inflammatory drugs, antitussives, mucolytics and broncho dilating aerosols 6.History or presence of allergic asthma, bronchiectasis, active tuberculosis, brochial carcinoma, hepatic or renal failure, cardiac failure 7.A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study 8.Individuals who are cognitively impaired and/or who are unable to give informed consent. 9.Any other health or mental condition that in the Investigatorâ??s opinion may adversely affect the subjectâ??s ability to complete the study or its measures or that may pose significant risk to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate including assessment of safety of the formulation with respect to adverse eventsTimepoint: â?¢ Visit 1 (Screening on Day 0) â?¢ Telephonic interview (Day 3) â?¢ Visit 2 (End of study visit on Day 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of efficacy will include: â?¢ Relief from various symptom of bronchitis like reduction in cough, sputum, fatigue and chest discomfort, etc. â?¢ Improvement in peak expiratory flow â?¢ ST. Georgeâ??s Respiratory Questionnaire (SGRQ) score â?¢ EQ5D- 5L questionnaire Timepoint: Visit 1 screening â?¢ Visit 2 (End of study visit on Day 7) | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappam
iDD Research Solutions Pvt. Ltd
Outcome results
None listed