Glycopyrrolate Inhalation for COPD

No longer recruiting at 6 trial locations

Overseen By Verona Pharma Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Verona Pharma plc

Must not be taking: Glucocorticoids, Anticholinergics

Disqualifiers: Asthma, Lung cancer, Glaucoma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an inhaled medication called glycopyrrolate to determine its effectiveness for people with COPD, a chronic lung disease that makes breathing difficult. Researchers aim to assess the safety and effectiveness of different doses compared to a placebo, which contains no active drug. Participants will try three different doses over separate weeks, with breaks in between, to identify the most effective dose. Suitable candidates have COPD symptoms that match specific guidelines and have smoked the equivalent of at least 10 cigarettes a day for 10 years. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial requires participants to stop using short-acting bronchodilators for 4 hours and BID LABA ± ICS therapy for 24 hours before spirometry testing. Other medication requirements are not specified in the protocol.

Is there any evidence suggesting that glycopyrrolate inhalation is likely to be safe for humans?

Research has shown that inhaled glycopyrrolate is generally safe for people with COPD. Studies indicate it does not significantly increase the risk of heart or blood vessel issues compared to a placebo. In fact, individuals using nebulized glycopyrrolate have reported it to be safe for the heart.

Long-term studies have also found that using glycopyrrolate inhalation over time is as safe as other common COPD treatments. While some side effects might occur, they are usually mild and not serious. However, it is important to note that it should not be used during a severe COPD attack.

Overall, inhaled glycopyrrolate appears safe and is well-tolerated for treating COPD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Glycopyrrolate inhalation is unique because it offers a more targeted delivery method for treating COPD symptoms directly in the lungs. Unlike standard treatments like long-acting beta-agonists or corticosteroids, glycopyrrolate is an anticholinergic that works by blocking specific receptors in the airways, leading to relaxation and opening of the air passages. Researchers are excited about this treatment because it has the potential to provide fast relief with fewer systemic side effects, making it a promising option for those with COPD.

What evidence suggests that glycopyrrolate inhalation could be an effective treatment for COPD?

Research has shown that inhaled glycopyrrolate can help people with COPD. One study found that glycopyrrolate significantly improved lung function compared to a placebo, allowing patients to breathe better. Another study demonstrated that glycopyrrolate quickly opened the airways, easing breathing. These improvements were both statistically significant and clinically important, suggesting it could help people with COPD breathe more easily. Overall, evidence supports glycopyrrolate as a promising option for improving lung health in COPD patients. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with COPD, a type of obstructive lung disease. Participants will use a jet nebulizer to inhale the study medication or placebo twice daily for one week during different periods.

Inclusion Criteria

Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines

I can use the study nebulizer correctly.

I agree to use contraception during and for 30 days after the study.

Exclusion Criteria

I have had issues with bladder emptying or needed a catheter in the last 6 months.

My kidney function is severely reduced.

I have a history of narrow angle glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive glycopyrrolate inhalation solution or placebo for 1 week, followed by a 1-week washout period. This cycle is repeated for four treatment periods.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Glycopyrrolate

Trial Overview The trial tests three doses of Glycopyrrolate (14 μg, 42.5 μg, and 85 μg) against a placebo to evaluate effectiveness and safety in managing COPD symptoms when administered via nebulizer over one-week treatment periods.

How Is the Trial Designed?

Group I: Dose Level C Experimental Treatment 1 Intervention

The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Group II: Dose Level B Experimental Treatment 1 Intervention

The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Group III: Dose Level A Experimental Treatment 1 Intervention

The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Group IV: Dose Level D Placebo Group 1 Intervention

The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Who Is Running the Clinical Trial?

Verona Pharma plc

Lead Sponsor

Trials

16

Recruited

3,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6003532/

Inhaled glycopyrrolate for the treatment of chronic obstructive ... The GLOW1 study showed that glycopyrrolate 50 µg QD had a rapid onset of bronchodilation in patients with COPD, with a significant improvement ...

2. nature.com nature.com/articles/s41533-021-00255-7

Impact of baseline clinical features on outcomes ... This review highlights outcomes among subpopulations of patients with comorbidities (eg, anxiety/depression, cardiovascular disease), and their impact on the ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422000485

Comparative Study on the effectiveness of Glycopyrrolate ... Comparative Study on the effectiveness of Glycopyrrolate/Formoterol versus Tiotropium/Formoterol in patients with Chronic Obstructive Pulmonary Disease.

4. resmedjournal.com resmedjournal.com/article/S0954-6111(17)30210-X/fulltext

Efficacy and safety of glycopyrrolate/eFlow® CS (nebulized ... The results of these studies demonstrated statistically significant and clinically important improvements in pulmonary function and patient- ...

5. journal.copdfoundation.org journal.copdfoundation.org/jcopdf/id/1099/Efficacy-and-Safety-of-Twice-Daily-Glycopyrrolate-Versus-Placebo-in-Patients-With-COPD-The-GEM2-Study

Efficacy and Safety of Twice-Daily Glycopyrrolate Versus ... Compared with placebo, glycopyrrolate showed significant improvements in lung function parameters (p<0.001). Health status (SGRQ total score and COPD assessment ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26316734/

Safety of inhaled glycopyrronium in patients with COPD Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports ...

7. mayoclinic.org mayoclinic.org/drugs-supplements/glycopyrrolate-inhalation-route/description/drg-20165175

Glycopyrrolate (inhalation route) - Side effects & dosage Safety and efficacy have not been established. ... COPD attack, severe—Should not be used if you are having a severe COPD attack, or if symptoms ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0954611116300452

Long-term safety of glycopyrrolate: A randomized study in ... GEM3 was a long-term safety (52 weeks) study in patients with COPD. · Long-term safety of glycopyrrolate 15.6 μg b.i.d. was comparable to indacaterol 75 μg q.d..