A study to assess the safety and efficacy of fixed dose combination of Montelukast 10 mg plus Acebrophylline SR 200 mg tablet in patients having bronchial asthma

Phase 4

Recruiting

• Conditions: Respiratory conditions due to other specified external agents,

• Registration Number: CTRI/2020/02/023237
• Lead Sponsor: Sun Pharma Laboratories Limited

Brief Summary

This is a phase IV, multi-centric, open-label, prospective study toevaluate safety and efficacy of fixed dose combination of Montelukast 10 mgplus Acebrophylline SR 200 mg tablet in patients having bronchial asthma. Approximately206 Male or female patients with age 18 - 65 years having confirmed diagnosisof asthma as per GINA 2018 guideline since at least 3 months prior to screeningand who are having current sign/ symptoms of asthma or need for SABA more thantwice a week will be enrolled in this study. Study consists of 05 visits (oneScreening Visit, one Baseline Visit, two Follow up Visits and one End ofTreatment Visit). Study duration will be of 14 weeks, including 02 weeks ofscreening period (maximum) and treatment duration of all enrolled patients willbe of 12 weeks.

**PrimaryOutcome measure: (Safety)**

·        Proportionof participants with adverse events and serious adverse events [Time frame: 84days]**Secondary outcomemeasure(s): (Efficacy)**

·        Change in Trough ForcedExpiratory Volume in 1 second (FEV1) from baseline to the end of treatment.[Time frame: 28, 56, 84 days]

·        Change in ASUI scorefrom baseline [Time frame: 28, 56, 84 days]

·        Change in Forced VitalCapacity from baseline. [Time frame: 28, 56, 84 days]

Number of rescue medication (Short acting beta-2agonists) used during study period. It shall be captured by Mean of occasions(not puffs) of SABA use per day, averaged over 1 week [Time frame: 28, 56, 84days]

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-03
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 206

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Primary Outcome measure: (Safety)	Time frame: 84 days
Proportion of participants with adverse events and serious adverse events	Time frame: 84 days

Secondary Outcome Measures

Name	Time	Method
Change in Trough Forced Expiratory Volume in 1 second (FEV1) from baseline to the end of treatment	Time frame: 28, 56, 84 days
Change in ASUI score from baseline	Time frame: 28, 56, 84 days
Change in Forced Vital Capacity from baseline	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 week	Time frame: 28, 56, 84 days

Trial Locations

Locations (14)

Apollo Hospitals; 🇮🇳 Hyderabad, TELANGANA, India

B.J, medical college and Civil hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dhanvantri OPD Block SMS Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Gandhi Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Government Fever Hospital, Government General Hospital; 🇮🇳 Guntur, ANDHRA PRADESH, India

Grant Government Medical College and Sir J J Group of hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

Institute of Medical Sciences & SUM Hospital; 🇮🇳 Khordha, ORISSA, India

IPGME&R and SSKM HOSPITAL; 🇮🇳 Kolkata, WEST BENGAL, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Lotus Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Scroll for more (4 remaining)

Apollo Hospitals

🇮🇳Hyderabad, TELANGANA, India

Dr Divyesh Kishen Waghray

Principal investigator

9866343831

andiv225@yahoo.com