glycopyrrolate inhalation (CHF 5259) / Chiesi - LARVOL DELTA

A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD (clinicaltrials.gov) - P2 | N=46 | Completed | Sponsor: Verona Pharma plc | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects with COPD (clinicaltrials.gov) - P2 | N=46 | Active, not recruiting | Sponsor: Verona Pharma plc | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison table: Inhaled drugs for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Drugs for COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tobacco Cessation

A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Verona Pharma plc | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Phase IIb Study of Glycopyrrolate Inhalation Solution Over 1 Week in Subjects With COPD (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Verona Pharma plc

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Impact of Indacaterol/Glycopyrrolate on Pulmonary Function and St. George's Respiratory Questionnaire Score in Individuals with Stable Chronic Obstructive Pulmonary Disease. (PubMed, Altern Ther Health Med) - "The conventional group received oral carbocisteine tablets, while the combined compound preparation group received indacaterol/glycopyrrolate inhalation powder spray in addition to the conventional treatment. In treatment of stable COPD patients, the combination of indacaterol/glycopyrrolate with carbocisteine tablets enhances pulmonary function, alleviates airway inflammatory reactions, improves clinical efficacy, enhances psychological resilience, and elevates the quality of life compared to carbocisteine tablets alone. These findings underscore the potential therapeutic benefits of the combined compound preparation in managing stable COPD."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL6 • TNFA

A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV) (clinicaltrials.gov) - P1 | N=95 | Completed | Sponsor: Chiesi Farmaceutici S.p.A. | Recruiting ➔ Completed

Trial completion • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV) (clinicaltrials.gov) - P1 | N=95 | Recruiting | Sponsor: Chiesi Farmaceutici S.p.A.

New P1 trial • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Budesonide/Glycopyrrolate/Formoterol Fumarate Co-suspension Metered Dose Inhaler: A Triple Therapy for the Treatment of Chronic Obstructive Pulmonary Disease. (PubMed, Ann Pharmacother) - "The findings from phase 3 trials support the efficacy and safety of triple therapy in COPD. Future studies are needed to confirm potential mortality benefit and the role of triple therapy in patients without an exacerbation history."

Journal • Candidiasis • Chronic Obstructive Pulmonary Disease • Dysphonia • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Clinically Important Deterioration Among Patients with Chronic Obstructive Pulmonary Disease (COPD) Treated with Nebulized Glycopyrrolate: A Post Hoc Analysis of Pooled Data from Two Randomized, Double-Blind, Placebo-Controlled Studies. (PubMed, Int J Chron Obstruct Pulmon Dis) - P3 | "Using a composite endpoint, pooled data from two 12-week Phase III placebo-controlled trials (GOLDEN 3, NCT02347761; GOLDEN 4, NCT02347774) were analyzed to determine whether glycopyrrolate inhalation solution (25 mcg and 50 mcg) administered twice daily (BID) via the eFlow Closed System nebulizer (GLY) reduced the risk of clinically important deterioration (CID) in patients with moderate-to-very-severe COPD...Subjects <65 years (OR 0.45 [0.29-0.68]) and those with PIFR <60 L/min (OR 0.36 [0.20-0.67]) exhibited the largest benefit. Nebulized GLY over 12 weeks significantly reduced the risk of CID and provided greater short-term stability in patients with moderate-to-very-severe COPD."

Clinical • Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Comparison table: Inhaled corticosteroids for treatment of COPD. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Chronic Obstructive Pulmonary Disease

A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease. (clinicaltrials.gov) - P4; N=46; Completed; Sponsor: Sunovion Respiratory Development Inc.; Recruiting ➔ Completed; N=20 ➔ 46

Clinical • Enrollment change • Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Satisfaction with the Use of eFlow Closed-System Nebulizer in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease: Findings from a Long-Term Safety Study. (PubMed, J Aerosol Med Pulm Drug Deliv) - "High levels of satisfaction, confidence, and ease of use were reported with the eFlow CS nebulizer in this study. These findings support the use of the eFlow CS for maintenance treatment of COPD with glycopyrrolate inhalation solution."

Clinical • Journal

A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease. (clinicaltrials.gov) - P4; N=20; Recruiting; Sponsor: Sunovion Respiratory Development Inc.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open

Effect of smoking status on lung function, patient-reported outcomes, and safety among COPD patients treated with glycopyrrolate inhalation powder: pooled analysis of GEM1 and GEM2 studies. (PubMed, Respir Res) - "In this post-hoc analysis of GEM1 and GEM2, glycopyrrolate use led to significant improvements in lung function, independent of baseline smoking status; improvements were less marked among patients receiving background ICS, regardless of baseline smoking status. Improvements in PROs were greater with glycopyrrolate than placebo, and the magnitude of changes was numerically greater among current smokers. The safety profile of glycopyrrolate was comparable between current smokers and ex-smokers."

Journal • Retrospective data

A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease. (clinicaltrials.gov) - P4; N=20; Active, not recruiting; Sponsor: Sunovion Respiratory Development Inc.; Not yet recruiting ➔ Active, not recruiting

Clinical • Enrollment closed