Health Condition 1: J40-J47- Chronic lower respiratory diseases
Conditions
Interventions
Intervention1: Acebrophylline 100mg + N-Acetylcysteine 600mg: The investigational product is a fixed-dose combination tablet containing Acebrophylline 100 mg and N-Acetylcysteine 600 mg. The pharmaceu
Sponsors
Win Medicare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and/or female aged greater than or equal to 18 years to less then or equal to 65 years 2. Clinically diagnosed of asthma, COPD, Chronic bronchitis associated with excessive mucous production. 2.1. Subjects having Modified Medical Research Council (MMRC) Scale grade of 2 or more (Attachment no. 1) 2.2. A post-bronchodilator forced expiratory volume in 1 second (FEV1) of at least 30 percent of the predicted value or above, and a post bronchodilator ratio of FEV1 to forced vital capacity (FVC) of less than 0.70. (Attachment no. 2) 2.3. Score greater than or equal to 5 points on the cough severity score (Attachment no. 3) 3. Subjects who will be able to provide written informed consent prior to the performance of any study specific procedures. 4. Female subjects of child-bearing potential with negative serum/urine pregnancy test at the time of screening. 5. Subjects who are willing and able to comply with all study assessments and adhere to the protocol schedule.
Exclusion criteria
Exclusion criteria: Subjects with a known history of hypersensitivity or allergy to the study drugs. Subjects receiving concomitant treatment for active or past pulmonary tuberculosis lung cancer bronchiectasis lung fibrosis destroyed lung or any other malignancy. Subjects diagnosed with recent acute coronary syndrome within the past twelve weeks or with a history or presence of acute myocardial infarction or cardiac arrhythmias. Subjects with a history of cerebrovascular disease without complete neurological recovery. Subjects with cognitive impairment that may affect study participation. Subjects with autoimmune disorders requiring concomitant treatment with corticosteroids. Subjects who develop worsening of chronic obstructive pulmonary disease symptoms during sputum induction. Subjects with hypotension or hypertension at the time of screening. Subjects with a history of epilepsy severe renal insufficiency or liver disease. Subjects with a history of gastroduodenal ulcer. Subjects suspected of having or diagnosed with pneumonia. Pregnant or lactating women or women of reproductive age who are unwilling to use a reliable method of contraception. Subjects taking any medication that may interfere with the study outcomes. Subjects who are unwilling or unable to provide written informed consent. Subjects who have participated in any clinical trial or received any investigational drug within thirty days prior to enrollment. Subjects with any severe acute or chronic medical condition that may affect their ability to participate in the study compromise subject safety or interfere with protocol compliance or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with adverse events and serious adverse events.Timepoint: Time frame: 4 week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of fixed dose combination of Acebrophylline 100mg and N-Acetylcysteine 600mg tablets for asthma, COPD and Chronic Bronchitis associated with excessive mucous production. 2. To evaluate the changes of clinical signs and symptoms of the conditions. 3. To evaluate the changes of quality of life of the study subjects with the help of QOL Questionnaire. Timepoint: Time Frame: Baseline, Week2, Week 4 | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
CliniExperts Research Services PVT LTD
Outcome results
None listed