Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2020/05/025323
CTRI/2020/05/025323
Not yet recruiting
Phase 3

A 12-week treatment, multi-centre, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy, safety, and tolerability of a fixed dose combination of nebulized Glycopyrronium 25mcg/ Arformoterol 15mcg solution for inhalation in comparison with Glycopyrronium 25mcg inhalation solution in subjects with chronic obstructive pulmonary disease.

Glenmark Pharmaceuticals Ltd0 sites0 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: J449- Chronic obstructive pulmonary disease, unspecified

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
Sponsor
Glenmark Pharmaceuticals Ltd
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Study of efficacy and safety of QVA149 compared to standard of care, acombination of fluticasone/salmeterol, in patients with moderate to severeCOPD
EUCTR2012-005102-22-CZovartis Pharma AG555
Active, not recruiting
Not Applicable
A multi-centre randomized double blind 12-week study to assess the efficacy, safety and tolerability of QVA149 in patients with COPD who have moderate to severe airflow limitatioChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2012-003346-32-PLovartis Pharma Services AG1,000
Completed
Phase 3
A 12 week study to assess theefficacy and safety of switching from salmeterol/fluticasone to QVA149 in symptomatic COPDpatients.
CTRI/2015/08/006128ovartis Healthcare Pvt Ltd88
Active, not recruiting
Not Applicable
A 12-week treatment, multi-center, randomized, double-blind, placebo controlled, parallel group study to assess the efficacy and safety of indacaterol (150 µg o.d.) in patients with chronic obstructive pulmonary disease.COPD: chronic obstructive pulmonary diseaseMedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
EUCTR2008-000301-11-DEovartis Pharma Services AG450
Active, not recruiting
Not Applicable
A multi-centre randomized double blind 12-week study to assess the efficacy, safety and tolerability of QVA149 in patients with COPD who have moderate to severe airflow limitatioChronic Obstructive Pulmonary Disease (COPD)MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
EUCTR2012-003347-30-HUovartis Pharma Services AG1,000