A Phase 1b Study of PUR1800 in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomised, placebo-controlled, double-blind 3-way crossover study in which
      PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD
      over three discrete TPs. Subjects will be randomised to one of the following 3 treatment
      sequences:

      Sequence Period 1 Period 2 Period 3

        1. Placebo PUR1800 250 μg PUR1800 500 μg

        2. PUR1800 250 μg Placebo PUR1800 500 μg

        3. PUR1800 250 μg PUR1800 500 μg Placebo

      Since this is the first study in humans in which the iSPERSE formulation is being
      administered, the 3 treatment sequences are designed in order to ensure that the lower dose
      of PUR1800 (250 μg) is administered prior to the administration of the higher dose of PUR1800
      (500 μg).
    

Detailed description: 
      The study design is as follows

      Informed Consent: Before any study specific procedures are conducted or study requirements
      are expected of a patient, the patient must review and sign an IEC-approved informed consent
      form.

      Screening: Subjects will be screened for eligibility to participate in the study within 28
      days before randomisation (i.e. TP1, Day 1).

      Treatment Periods:

      Period 1: On Day 1 all subjects who are eligible for entry into the study will be randomised
      to 1 of 3 treatment sequences and receive either placebo or the lowest nominal dose of
      PUR1800 (PUR1800 250 μg) for 14 consecutive days.

      Period 2: Following a washout period of at least 28 days after the completion of Period 1
      dosing, subjects will receive a treatment other than what the subject received during Period
      1 for 14 consecutive days.

      Period 3: Following a washout period of at least 28 days after the completion of Period 2
      dosing, subjects will receive the treatment that the subject had not received during Periods
      1 or 2 (either placebo or PUR1800, 500 μg) for 14 consecutive days.

      End of Study (EOS): Subjects will return to the study site 28 days after the last dose of the
      last TP (or in the event of early withdrawal after the last dose received, if possible) for
      an EOS visit. Unscheduled visits are permitted at the discretion of the investigator.
    

Intervention name(s): Placebo Comparator; PUR1800 250 ug; PUR1800 500 ug
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning.; The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 250 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning.; The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 500 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: PUR1800, or placebo is dosed daily for 14 consecutive days in adult subjects with stable COPD over three discrete TPs. Subjects will be randomised to one of the following 3 treatment sequences: Sequence Period 1 Period 2 Period 3
Placebo PUR1800 250 μg PUR1800 500 μg
PUR1800 250 μg Placebo PUR1800 500 μg
PUR1800 250 μg PUR1800 500 μg Placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment