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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 1b Study of PUR1800 in Patients With COPD

NCT04759807

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED PHASE1

Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118

NCT01333904

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE1

A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease

NCT01033487

Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases +2 more

COMPLETED PHASE2

Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

NCT00783406

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE2

A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

NCT00559910

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PUR0200 low dose

PUR0200 low dose, single dose inhalation

Group Type EXPERIMENTAL

PUR0200

Intervention Type DRUG

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

PUR0200 mid dose

PUR0200 mid dose, single dose inhalation

Group Type EXPERIMENTAL

PUR0200

Intervention Type DRUG

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

PUR0200 high dose

PUR0200 high dose, single dose inhalation

Group Type EXPERIMENTAL

PUR0200

Intervention Type DRUG

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

Placebo

PUR0200 matched placebo, single dose, inhalation

Group Type PLACEBO_COMPARATOR

PUR0200 Placebo

Intervention Type DRUG

Randomized, single dose of inhaled placebo matched to PUR0200

Active Comparator

Active Comparator, single dose, inhalation

Group Type ACTIVE_COMPARATOR

Active comparator

Intervention Type DRUG

Randomized single dose of inhaled active comparator product

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PUR0200

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

Intervention Type DRUG

PUR0200 Placebo

Randomized, single dose of inhaled placebo matched to PUR0200

Intervention Type DRUG

Active comparator

Randomized single dose of inhaled active comparator product

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No