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A Phase IIb Ensifentrine-glycopyrrolate Fixed-dose Combination Dose Ranging Study in Subjects With COPD

ConditionChronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorVerona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

About this trial

This study will assess the safety and efficacy of fixed dose combinations of ensifentrine with two different glycopyrrolate dose levels compared to placebo and to the individual components of the fixed dose combinations, each administered twice a day via standard jet nebulizer, in adult subjects with chronic obstructive pulmonary disease (COPD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males are eligible to participate if they agree to use contraception or abstinence, and refrain from donating fresh unwashed semen during the study and for at least 30 days post-study

Not a woman of child-bearing potential OR

Agrees to follow the contraceptive guidance from screening throughout the study and for at least 30 days post-study

Agrees not to donate eggs for the purpose of reproduction from screening throughout the study and for at least 30 days post-study

Disqualifiers

Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure [CPAP] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease

Within 6 months prior to randomization, a COPD exacerbation requiring hospitalization

Within 3 months prior to randomization, use of oral or systemic therapies for COPD exacerbations (for example, oral, intravenous, or intramuscular glucocorticoids, antibiotics, theophylline, and roflumilast)

History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ensifentrine 3 mg

    Drug

    Administered by a standard jet nebulizer, twice daily for 28 consecutive days

  • Glycopyrrolate 21.25 mcg

    Drug

    Administered by a standard jet nebulizer, twice daily for 28 consecutive days

  • Glycopyrrolate 42.5 mcg

    Drug

    Administered by a standard jet nebulizer, twice daily for 28 consecutive days

  • Placebo

    Drug

    Administered by a standard jet nebulizer, twice daily for 28 consecutive days

Treatment groups

480 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Treatment Arm A: Ensifentrine plus GlycopyrrolateExperimental treatment 2 interventions
Group B: Treatment Arm B: Ensifentrine plus GlycopyrrolateExperimental treatment 2 interventions
Group C: Treatment Arm C: GlycopyrrolateActive comparator 1 intervention
Group D: Treatment Arm D: GlycopyrrolateActive comparator 1 intervention
Group E: Treatment Arm E: EnsifentrineActive comparator 1 intervention
Group F: Treatment Arm F: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in average forced expiry volume in 1 second (FEV1) area under the curve versus time, from time 0 to 4 hours (AUC0-4h)

Time frame
Baseline and Day 28

Secondary outcomes

1

Change from baseline in peak FEV1 measured over 4 hours post-dose

Time frame
Baseline and Day 28
2

Change from baseline in average FEV1 area under the curve versus time, from time 0 to 12 hours (AUC0-12h)

Time frame
Baseline and Day 28
3

Change from baseline in morning trough FEV1 on Day 29

Time frame
Baseline and Day 29
4

Change from baseline in evening trough FEV1 on Day 28

Time frame
Baseline and Day 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Verona Pharma, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA

Lead sponsor

Source ClinicalTrials.gov
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