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Anticholinergic

Glycopyrrolate Inhalation for COPD

Phase 2
Recruiting
Research Sponsored by Verona Pharma plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Capable of using the study nebulizer correctly
Subjects with an established clinical history of COPD as defined by ATS/ERS guidelines with symptoms compatible with COPD
Must not have
History of narrow angle glaucoma
Major surgery in the 6 weeks prior to Screening or lack of full recovery from surgery at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to test the effectiveness, safety, and how the body processes different doses of a medication called glycopyrrolate inhalation solution in patients with chronic obstructive pulmonary disease (COP

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Glycopyrrolate may cause dry mouth, sore throat, headache, urinary retention, constipation, blurred vision and can worsen narrow-angle glaucoma or lead to difficulty urinating.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can use the study nebulizer correctly.
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I have been diagnosed with COPD according to official guidelines.
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I have smoked at least 10 pack-years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of narrow angle glaucoma.
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I have not had major surgery in the last 6 weeks or I have fully recovered from any recent surgery.
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My kidney function is severely reduced.
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I have a lung condition that is not COPD.
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I had lung surgery less than a year ago.
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I use oxygen therapy for more than 12 hours daily.
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I do not have severe health issues like unstable heart conditions.
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I have not had any cancer in the past 5 years, except for skin cancer.
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I haven't had a COPD flare-up or used treatments for it in the last 6 months.
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I have not had a lung infection in the last 6 weeks and do not currently have an infection.
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I have a severe lung condition that has been life-threatening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose Level CExperimental Treatment1 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 BExperimental Treatment1 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 AExperimental Treatment1 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 DPlacebo Group1 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

Find a Location

Who is running the clinical trial?

Verona Pharma plcLead Sponsor
15 Previous Clinical Trials
2,997 Total Patients Enrolled
~0 spots leftby Dec 2024
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