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Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

PUR118

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Main Inclusion Criteria Parts I & II

Healthy males or non pregnant, non lactating healthy females;
Age 18-65 years of age;
Must be willing and able to communicate in English and participate in the whole study;
Must provide written informed consent.

Main Exclusion Criteria Parts I & II

Current smokers and those who have smoked within the last 12 months;
Females of child bearing age not willing to use an acceptable form of contraception;
Presence or history of allergy requiring treatment;
Serious adverse reaction or hypersensitivity to any drug;

Main Inclusion Criteria: Parts III and IV

Males or non pregnant, non lactating females;
Age 45-70 years;
Current (Part III only) or ex-smokers who at least a 15 pack-year smoking history. For Part IV, subjects must be non-smokers for at least 3 months;
Medically stable, with no evidence of uncontrolled co-existing conditions at screening;
Must not be taking any inhaled or oral corticosteroids;
FEV1/FVC ratio <70% and FEV1 60 - 80% (or >/= 60% for Part IV only) of predicted following administration of a bronchodilator;
Patients must have a medical history of COPD confirmed by their General Practitioner (GP) or treating hospital physician or must have a chest x-ray (CXR) which is normal or consistent with mild COPD and excludes other clinically significant respiratory abnormalities;
Must be willing and able to communicate in English and participate in the whole study;
Must provide written informed consent.

Main Exclusion Criteria: Parts III and IV

Must agree to use an adequate method of contraception;
Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 60 days;
Patients taking medication that may affect the respiratory tract within 14 days of the first study day other than their usual COPD medication;
No active exacerbations requiring antibiotics or steroids within 60 days of dosing.

Sites / Locations

Quotient Bioresearch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PUR118

Arm Description

Outcomes

Primary Outcome Measures

Safety and tolerability assessed by changes in clinical signs and symptoms, clinical safety laboratory tests, vital signs, ECG, spirometry, oxygen saturation, telemetry and adverse events

Secondary Outcome Measures

Assessment of biomarkers of inflammation and COPD in induced sputum in mild COPD subjects after short multi-dosing with PUR118 compared to baseline

Assessment of changes in mucociliary clearance after treatment with PUR118 in mild COPD subjects compared to baseline

Full Information

NCT ID

NCT01333904

First Posted

April 7, 2011

Last Updated

September 6, 2012

Sponsor

Pulmatrix Inc.

Collaborators

Quotient Bioresearch

1. Study Identification

Unique Protocol Identification Number

NCT01333904

Brief Title

Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118

Official Title

A Four-Part Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of PUR118 and Placebo in Normal Healthy Volunteers and Subjects With COPD

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pulmatrix Inc.

Collaborators

Quotient Bioresearch

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to establish single and multiple dose safety in healthy subjects and subjects with mild chronic pulmonary obstructive disease (COPD). In addition, the study will evaluate preliminary proof of concept endpoints in COPD subjects such as biomarkers in sputum and mucociliary clearance.

Detailed Description

The proposed initial trial in healthy subjects and subjects with mild COPD will establish the tolerability of PUR118 in these subjects over single and short multi-day dosing periods. The study will also provide preliminary data regarding PUR118's potential impact on biomarkers in COPD. Finally, this trial will assess PUR118's effect on mucociliary clearance. This is a four part study enrolling healthy volunteers in a single ascending dose design (SAD; Part I), followed by multiple ascending dose design (MAD; Part II). Contingent on demonstration of safety in a healthy subject population, the study will enroll mild COPD subjects for a short multi-dose design (Part III) incorporating safety and pharmacodynamic endpoints. Lastly Part IV of the trial will assess the effect of PUR118 on mucociliary clearance in mild COPD subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PUR118

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

PUR118

Intervention Description

inhaled

Primary Outcome Measure Information:

Title

Safety and tolerability assessed by changes in clinical signs and symptoms, clinical safety laboratory tests, vital signs, ECG, spirometry, oxygen saturation, telemetry and adverse events

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Assessment of biomarkers of inflammation and COPD in induced sputum in mild COPD subjects after short multi-dosing with PUR118 compared to baseline

Time Frame

2 days

Title

Assessment of changes in mucociliary clearance after treatment with PUR118 in mild COPD subjects compared to baseline

Time Frame

single dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria Parts I & II Healthy males or non pregnant, non lactating healthy females; Age 18-65 years of age; Must be willing and able to communicate in English and participate in the whole study; Must provide written informed consent. Main Exclusion Criteria Parts I & II Current smokers and those who have smoked within the last 12 months; Females of child bearing age not willing to use an acceptable form of contraception; Presence or history of allergy requiring treatment; Serious adverse reaction or hypersensitivity to any drug; Main Inclusion Criteria: Parts III and IV Males or non pregnant, non lactating females; Age 45-70 years; Current (Part III only) or ex-smokers who at least a 15 pack-year smoking history. For Part IV, subjects must be non-smokers for at least 3 months; Medically stable, with no evidence of uncontrolled co-existing conditions at screening; Must not be taking any inhaled or oral corticosteroids; FEV1/FVC ratio <70% and FEV1 60 - 80% (or >/= 60% for Part IV only) of predicted following administration of a bronchodilator; Patients must have a medical history of COPD confirmed by their General Practitioner (GP) or treating hospital physician or must have a chest x-ray (CXR) which is normal or consistent with mild COPD and excludes other clinically significant respiratory abnormalities; Must be willing and able to communicate in English and participate in the whole study; Must provide written informed consent. Main Exclusion Criteria: Parts III and IV Must agree to use an adequate method of contraception; Upper respiratory tract infection within 30 days of the first study day, or lower respiratory tract infection within the last 60 days; Patients taking medication that may affect the respiratory tract within 14 days of the first study day other than their usual COPD medication; No active exacerbations requiring antibiotics or steroids within 60 days of dosing.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stuart Mair, MD

Organizational Affiliation

Quotient Bioresearch

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quotient Bioresearch

City

Nottingham

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

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Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118

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