A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients

A Phase I, 2-Part, Single-dose, Placebo and Active-Controlled, Dose-ranging, Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01921712

Enrollment

Registered

2013-08-13

Start date

2013-07-31

Completion date

2013-12-31

Last updated

2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, Chronic Obstructive Pulmonary Disease

Brief summary

The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.

Detailed description

This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.

Interventions

DRUGPUR0200

Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator

DRUGPUR0200 Placebo

Randomized, single dose of inhaled placebo matched to PUR0200

DRUGActive comparator

Randomized single dose of inhaled active comparator product

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * A clinical diagnosis of moderate to severe COPD according to the following criteria: * Current or ex-smokers with at least 10 pack-year smoking history * Post-bronchodilator FEV1 \>/= 35% and \</= 80% of predicted normal value * Post-bronchodilator FEV1/FVC (forced vital capacity) ratio \<0.70 * Post-bronchodilator improvement in FEV1 \>/= 100 mL Key

Exclusion criteria

* Current evidence or recent history of clinically significant or unstable disease (other than COPD) * Current diagnosis of asthma * Presence of history of clinically significant allergy requiring treatment * COPD exacerbation within 6 weeks * Use of daily oxygen therapy \> 10 hours * Thoracotomy with pulmonary resection * Use of systemic steroids within 3 months * Lower respiratory tract infection within 30 days * Upper respiratory tract infection within 30 days requiring treatment with antibiotics * History of tuberculosis, bronchiectasis, or other non-specific pulmonary disease * Prolonged corrected QT (QTc) interval \>450 msec males and \>470 msec females, or history of long QT syndrome

Design outcomes

Primary

Measure	Time frame	Description
Peak plasma concentration (Cmax) of PUR0200	0 to 24 hours	—
Time to reach peak plasma (Tmax) concentration of PUR0200	0 to 24 hours	—
Area under the plasma concentration versus time (AUC) of PUR0200	0 to 24 hours	—
Trough forced expiratory volume in 1 second (FEV1)	24 hours	—
Trough FEV1 difference from baseline	24 hours	—
Number of participants with adverse events	up to 14 days post-dose	adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026