Safety, Tolerability, and Pharmacodynamic Effect Study of PUR118

This study has been completed.
Sponsor:
Collaborator:
Quotient Bioresearch
Information provided by (Responsible Party):
Pulmatrix Inc.
ClinicalTrials.gov Identifier:
NCT01333904
First received: April 7, 2011
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: PUR118
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pulmatrix Inc.:

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 [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Assessment of changes in mucociliary clearance after treatment with PUR118 in mild COPD subjects compared to baseline [ Time Frame: single dose ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: February 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PUR118 Drug: PUR118
inhaled

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333904

Locations
United Kingdom
Quotient Bioresearch
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Pulmatrix Inc.
Quotient Bioresearch
Investigators
Principal Investigator: Stuart Mair, MD Quotient Bioresearch
  More Information

No publications provided

Responsible Party: Pulmatrix Inc.
ClinicalTrials.gov Identifier: NCT01333904     History of Changes
Other Study ID Numbers: 601-0004
Study First Received: April 7, 2011
Last Updated: September 6, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2014