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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01921712
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : March 18, 2014
Sponsor:
Collaborator:
Quotient Clinical
Information provided by (Responsible Party):
Pulmatrix Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: PUR0200 Drug: PUR0200 Placebo Drug: Active comparator Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: PUR0200 low dose
PUR0200 low dose, single dose inhalation
Drug: PUR0200
Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator

Experimental: PUR0200 mid dose
PUR0200 mid dose, single dose inhalation
Drug: PUR0200
Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator

Experimental: PUR0200 high dose
PUR0200 high dose, single dose inhalation
Drug: PUR0200
Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator

Placebo Comparator: Placebo
PUR0200 matched placebo, single dose, inhalation
Drug: PUR0200 Placebo
Randomized, single dose of inhaled placebo matched to PUR0200

Active Comparator: Active Comparator
Active Comparator, single dose, inhalation
Drug: Active comparator
Randomized single dose of inhaled active comparator product




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921712


Locations
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United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Quotient Clinical
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Pulmatrix Inc.
Quotient Clinical
Investigators
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Study Director: David Hava, Ph.D. Pulmatrix Inc.

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Responsible Party: Pulmatrix Inc.
ClinicalTrials.gov Identifier: NCT01921712     History of Changes
Other Study ID Numbers: 601-0010P
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Pulmatrix Inc.:
COPD
Chronic Obstructive Pulmonary Disease

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