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

Pulmatrix

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: PUR0200; Drug: PUR0200 Placebo; Drug: Active comparator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01921712

601-0010P

Details and patient eligibility

About

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.

Full description

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

Enrollment: 38 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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38 participants in 5 patient groups, including a placebo group

PUR0200 low dose

Experimental group

Description:

PUR0200 low dose, single dose inhalation

Treatment:

Drug: PUR0200

PUR0200 mid dose

Experimental group

Description:

PUR0200 mid dose, single dose inhalation

Treatment:

Drug: PUR0200

PUR0200 high dose

Experimental group

Description:

PUR0200 high dose, single dose inhalation

Treatment:

Drug: PUR0200

Placebo

Placebo Comparator group

Description:

PUR0200 matched placebo, single dose, inhalation

Treatment:

Drug: PUR0200 Placebo

Active Comparator

Active Comparator group

Description:

Active Comparator, single dose, inhalation

Treatment:

Drug: Active comparator