Badanie skuteczności PF‑07275315 u dorosłych z umiarkowaną‑do‑ciężką przewlekłą obturacyjną chorobą płuc (COPD) – randomizowane, podwójnie ślepe, placebo‑kontrolowane

Randomization and first injection

After joining the study you are assigned by a computer to receive either placebo or PF-07275315. the assignment is unknown to you and the study staff who interact with you.

The first dose is given as a subcutaneous (under the skin) injection of a solution for injection. The recorded dose in the study documents is 0 mg for both groups.

Baseline assessments

Immediately after the first injection you undergo baseline measurements that include a lung function test called forced expiratory volume in one second (FEV1), a test of lung capacity called forced vital capacity (FVC), and questionnaires that evaluate breathing difficulty and quality of life.

These results are used as the reference point for all later comparisons.

Regular follow‑up visits during phase 2 (up to week 24)

You return to the study site at scheduled intervals, typically every 4 weeks, for additional injections and safety checks.

At each visit lung function tests (FEV1 and FVC) are repeated, vital signs are recorded, and any side effects are documented.

The primary efficacy measurement for phase 2 is the change in pre‑bronchodilator FEV1 at week 24 compared with the baseline value.

Continuation to phase 3 (up to week 52)

If you remain in the study after week 24, treatment continues under the same double‑blind conditions for an additional period up to week 52.

Follow‑up visits continue at similar intervals, and lung function tests are performed at week 12 and week 52.

The primary efficacy measurement for phase 3 is the yearly rate of moderate or severe exacerbations of chronic obstructive pulmonary disease (COPD).

Final assessments and study completion

At the end of week 52 a final set of measurements is performed, including lung function tests, questionnaires, and a review of any adverse events that occurred during the study.

After these assessments you are discharged from the study and no further study‑specific medication is given.