A study to evaluate efficacy and safety of combination of Glycopyrronium 25mcg/ Arformoterol 15mcg solution for inhalation in patients with chronic obstructive pulmonary disease.
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2020/05/025323
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male or female, aged >40 (40 years completed) to <=75 years at the time of informed consent.
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.
Patients with a diagnosis of COPD for a period of at least 6 months prior to screening visit
Patients receiving stable treatment for COPD for at least 1 month before screening, i.e. no change in the dose, dosing regimen, medication and other interventions for COPD for at least 1 month before screening.
Patients currently not receiving a fixed or free combination of long-acting muscarinic antagonist (LAMA) and long-acting beta-2 agonist (LABA), with or without inhaled corticosteroid.
Post-bronchodilator FEV1 >=30% and <80% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) ratio < 0.70
A modified Medical Research Council dyspnoea scale (mMRC) grade 2 or greater.
Provide written informed consent
Female subjects must have a negative pregnancy test at Screening Visit , and agree to use an adequate forms of non-hormonal contraception during the study (i.e., women of child bearing potential must use a highly effective method of birth control, such as condom and spermicide, diaphragm or cervical cap and spermicide, condom and diaphragm or cervical cap, non-hormonal IUD), or females who are of non-child bearing potential i.e., who are surgically sterile (history of hysterectomy or bilateral tubal ligation or bilateral oophorectomy; partial hysterectomy is not sufficient or vasectomized partner) or postmenopausal (12 months of spontaneous amenorrhea) or who agree to remain abstinent.
Male subjects must agree to either remain abstinent or use a highly effective method of birth control as described above.
Willing and able to comply with all aspects of the protocol.
Ability to use the inhalation devices independently & correctly.
History or current diagnosis of asthma
Known respiratory disorders other than COPD including but not limited to alpha-1 antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease.
Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation (including the mild COPD exacerbation) within 6 weeks prior to screening or during the run-in period
Hospitalization for COPD exacerbation or pneumonia within 3 months prior to Screening Visit.
Chest X-ray or CT scan, which reveals evidence of clinically significant abnormalities, not believed to be due to the presence of COPD (e.g., evidence of pneumonia, other infection, atelectasis, or pneumothorax)..
.
Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy (Subjects with a transurethral resection of prostate, subjects who have undergone full re-section of the prostate will be considered for the study, as well as subjects who are asymptomatic and stable on pharmacological treatment for the condition).
Use of oral/depot corticosteroids or antibiotics for COPD within 6 weeks prior to Screening Visit or subject has had a change in dose or type of any medications for COPD within 1 month before the Screening Visit.
Has a clinically relevant laboratory abnormality or a clinically significant condition, in the judgment of the investigator, such as (but not limited to):
Unstable ischemic heart disease, left ventricular failure (New York Heart Association Class III and IV), history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation). Subjects with such events not considered clinically significant by the investigator will be considered for inclusion in the study
Uncontrolled hypo- or hyperthyroidism, hypokalaemia or hyperadrenergic state or any condition, which might compromise subject safety or compliance, interfere with evaluation, or preclude completion of the study.
An abnormal and clinically significant 12-lead electrocardiogram (ECG) as per investigatorâ??s discretion. For the purposes of this study, an abnormal ECG will be defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:
Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome)
Myocardial ischemia
Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia)
A QTcF value at screening >=450 msec (for males) / >=470 msec (for females)
Patients with abnormal liver function tests defined as Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or total bilirubin >= 2.5 times upper limit of normal ranges at screening
Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in peak FEV1 at week 12 (day 85)Timepoint: Week 12 (day 85)
- Secondary Outcome Measures
Name Time Method Change from baseline in mMRC score at week 12Timepoint: Week 12;Change from baseline in standardized FEV1 AUC0-2 h, at week 12 (Day 85)Timepoint: Week 12;Change from baseline in total daily symptom score, daytime symptom score and night-time symptom score at week 12Timepoint: Week 12;Change from baseline in trough FEV1 at week 12 (Day 86)Timepoint: Week 12;Change from baseline in trough forced vital capacity (FVC) at week 12 (Day 86)Timepoint: Week 12;Treatment Emergent Adverse Events (TEAE) throughout the study periodTimepoint: Throughout the study period