Efficacy and safety study to assess between three drugs (Inhaler) in patients with Chronic Obstructive Pulmonary Disease

Phase 3

• Conditions: Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

• Registration Number: CTRI/2023/01/048668
• Lead Sponsor: upin Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Subjects meeting all the following criteria will be participating in the trial:

1.Male or female patients, aged >=18 to <= 75 years at screening

2.Patients with a diagnosis of COPD (as defined by the GOLD Guidelines, 2021)

3.Post-bronchodilator FEV1 >=30% and <80% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) ratio < 0.70

4.A modified Medical Research Council dyspnoea scale (mMRC) grade 2 or greater

5.History of exacerbations (>=2 moderate or >=1 severe exacerbation) of COPD within 12 months before screening

6.Subjects on inhaled corticosteroid (ICS) with or without a long-acting β2 agonist (LABA) (as a free or fixed combination), or ICS with a long- acting muscarinic antagonist (LAMA), or LABA with LAMA (as a free or fixed combination), or LAMA monotherapy as maintenance treatment for at least 1 month before screening

7.Current or previous cigarette/beedi smokers with a history of cigarette/beedi smoking of at least 10 pack/years. (Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Screening Visit)

Exclusion Criteria

1.Patients who are currently receiving triple drug treatment with LABA+LAMA+ICS

2.Known respiratory disorders other than COPD including, but not limited to the following: asthma, tuberculosis, alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.

3.Evidence or history of other clinically significant cardiovascular disease or abnormality (such as, but not limited to, congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, arrhythmia, long QT syndrome, atrial fibrillation), renal, neurological, endocrine, immunological, psychiatric, hepatic, or hematological disease or abnormality which, in the opinion of the investigator, are clinically significant and would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates during the study

4.Significant abnormality that suggests chest disease other than COPD, on chest X-ray or computed tomography (CT) scan taken within six months before screening. If there is no chest X-ray/CT scan is taken within six months prior to screening, a chest X-ray will be performed during screening to rule out any other significant abnormality

5.History of paradoxical bronchospasm, uncontrolled narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, or severe renal impairment or urinary retention or any other condition, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic or long-acting beta-agonist agent

6.History of allergy or hypersensitivity to any of the ingredients of study drugs or components of the delivery system

7.Suspected or confirmed SARS-COV2 infection at screening (prior to randomization the subjects will be tested for COVID 19 through rapid antigen test).

8.Hospitalization for COPD exacerbation or pneumonia within three months prior to screening. Any subject who experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded

9.Use of oral/parenteral corticosteroids or antibiotics for COPD exacerbation within six weeks prior to screening

10.Clinically significant abnormal electrocardiogram (ECG) finding at screening

11.Lung volume reduction surgery within 12 months prior to the initiation of the study

12.Requirement of long term ( > 12 hours daily) oxygen therapy

13.Unable to stop the following medications at the defined times prior to screening spirometry:

Medication Required washout period prior to screening spirometry

Ipratropium or 8 Hrs

ipratropium/salbutamol

combination product

Inhaled short acting β-agonists 6 hours

Oral β 2-agonists 48 hours

Long acting β-agonists

(salmeterol and formoterol)

or ICS/LABA combination products 48 hours

Xanthines 48 hours

Cromolyn and nedocromil inhalers 24 hours

Zafirlukast, montelukast, zileuton 48 hours

Long-acting anticholinergics

(Tiotropium etc.) 48 hours

Oral or parenteral corticosteroids 6 weeks

Any other investigational me

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in trough FEV1Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
1. Change from baseline in Trough FEV1 <br/ ><br>2.Change from baseline in 2 h post-dose FEV1 <br/ ><br>3.Proportion of patients requiring use of rescue medication over treatment period <br/ ><br>4. Proportion of patients with COPD exacerbations during the treatment period <br/ ><br>5. Change from baseline in mMRC scoreTimepoint: 1.week 4 and week 8 <br/ ><br>2.week 12 <br/ ><br>3.week 12 <br/ ><br>4.week 12 <br/ ><br>5. week 4, week 8 and week 12