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Completed

NCT Number: NCT01921712

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medicines Evaluation Unit, Manchester, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PUR0200

Drug

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

PUR0200 Placebo

Drug

Randomized, single dose of inhaled placebo matched to PUR0200

Active Comparator

Drug

Randomized single dose of inhaled active comparator product

Primary outcomes

  1. Peak plasma concentration (Cmax) of PUR0200

    Time frame: 0 to 24 hours

  2. Time to reach peak plasma (Tmax) concentration of PUR0200

    Time frame: 0 to 24 hours

  3. Area under the plasma concentration versus time (AUC) of PUR0200

    Time frame: 0 to 24 hours

  4. Trough forced expiratory volume in 1 second (FEV1)

    Time frame: 24 hours

  5. Trough FEV1 difference from baseline

    Time frame: 24 hours

  6. Number of participants with adverse events

    Time frame: up to 14 days post-dose

    adverse events, vital signs, clinical laboratory changes, and ECG changes will be evaluated

Sponsors and collaborators

Lead sponsor

Pulmatrix Inc.

Industry

Collaborators

  • Quotient Clinical

Registry information

Official study 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)

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 13, 2013
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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