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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921712
• Other study ID #: 601-0010P
• Status: Completed
• Phase: Phase 1
• First received: August 9, 2013
• Last updated: March 17, 2014
• Start date: July 2013
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Pulmatrix Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PUR0200
Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
• PUR0200 Placebo
Randomized, single dose of inhaled placebo matched to PUR0200
• Active comparator
Randomized single dose of inhaled active comparator product

Locations

Country	Name	City	State
United Kingdom	Medicines Evaluation Unit	Manchester
United Kingdom	Quotient Clinical	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Pulmatrix Inc.	Quotient Clinical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak plasma concentration (Cmax) of PUR0200		0 to 24 hours	No
Primary	Time to reach peak plasma (Tmax) concentration of PUR0200		0 to 24 hours	No
Primary	Area under the plasma concentration versus time (AUC) of PUR0200		0 to 24 hours	No
Primary	Trough forced expiratory volume in 1 second (FEV1)		24 hours	No
Primary	Trough FEV1 difference from baseline		24 hours	No
Primary	Number of participants with adverse events	adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated	up to 14 days post-dose	No