Glycopyrrolate Inhalation for COPD

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

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized, double-blind, placebo-controlled complete block cross-over study designed to assess the efficacy, safety, and pharmacokinetics of 3 dose levels of glycopyrrolate inhalation solution delivered twice daily via standard jet nebulizer over three 1-week active treatment periods and one 1-week placebo period in subjects with chronic obstructive pulmonary disease (COPD).

Eligibility Criteria

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

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

I can use the study nebulizer correctly.

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

Exclusion Criteria

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

I have a history of narrow angle glaucoma.

I have not had major surgery in the last 6 weeks or I have fully recovered from any recent surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+