Health Condition 1: J708- Respiratory conditions due to other specified external agents
Conditions
Interventions
Intervention1: FDC of Montelukast 10 mg and Acebrophylline SR 200 mg tablet: Dosage and Administration- Each patient will receive Montelukast 10 mg plus Acebrophylline SR 200 mg tablet to be consumed
Sponsors
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female patient with age 18 - 65 years (both inclusive) 2.Patient having confirmed diagnosis of asthma as per GINA 2018 guideline since at least 3 months prior to screening 3.Patient having current sign/symptoms of asthma or need for SABA more than twice a week 4.Patient who is suitable to take Montelukast and Acebrophylline as per GINA 2018 guideline 5.Female patient of childbearing potential, willing to use effective contraception during the study and willing to undergo pregnancy test. Effective contraceptive include (e.g. barrier method with spermicide). The "calendar method," withdrawal, or an IUD is NOT an acceptable method ? 6.Except asthma disorder patient is judged to be in general good health to participate in trial based on medical history and physical examination as assessed by the Investigator 7.Written informed consent signed by patient and willing to comply with the study procedure
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating female patient 2.Hospitalization due to exacerbation of asthma within the previous 12 weeks preceding study entry (screening visit) 3.Patient with clinically relevant upper respiratory tract infection 4 weeks prior or lower respiratory tract infection 8 weeks prior to the screening visit as judged by investigators 4.Patient has a history of oral or parenteral steroids 4 weeks prior & depot steroid 12 weeks prior to enrollment 5.Patient who had received leukotriene antagonist and/ or Acebrophylline within 3 days of enrolment 6.Patient with concurrent, previous or possible alcohol dependence, drug dependence or narcotic addiction as per DSM-5 7.Patient who have earlier participated in any other clinical trial within three months of screening 8.Patient with a known history of clinically significant (including but not limited to) acute myocardial infarction, impaired hemodynamics, psychiatric, hepatic or/and renal disorders, Ambroxol allergy, GI disorders, phenylketonuria, pneumonia, pulmonary fibrotic disease, active tuberculosis, chronic obstructive pulmonary disease (COPD) or pneumothorax convulsion, arrhythmia, CAD, cardiac insufficiency and hyperthyroidism 9.Patient with known history of Hypersensitivity to Acebrophylline or Montelukast or any other leukotriene antagonists or asprin or theophylline or any other xanthine derivative 10.History of hepatitis B, hepatitis C or HIV infection 11.Patient with type 2 diabetes (HbA1c > 9 % at screening) 12.Patient with current history of uncontrolled hypertension (SeSBP = 140 and/ or SeDBP = 90 mm of Hg) 13.Current smoker or past smoker with a smoking history of = 10 pack years 14.Patient with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patient’s safety and efficacy of the drug 15.Patient judged unfit for this study by investigator 16.Investigator, study personnel, sponsor representatives and their first degree relatives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Primary Outcome measure: (Safety) Proportion of participants with adverse events and serious adverse eventsTimepoint: Time frame: 84 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ASUI score from baselineTimepoint: Time frame: 28, 56, 84 days;Change in Forced Vital Capacity from baselineTimepoint: Time frame: 28, 56, 84 days;Change in Trough Forced Expiratory Volume in 1 second (FEV1) from baseline to the end of treatmentTimepoint: Time frame: 28, 56, 84 days;Number of rescue medication (Short acting beta-2 agonists) used during study period. It shall be captured by Mean of occasions (not puffs) of SABA use per day, averaged over 1 weekTimepoint: Time frame: 28, 56, 84 days | — |
Countries
India
Contacts
Public ContactNilesh Kadam
Sun Pharma Laboratories Limited
Outcome results
None listed