Testing the effects of a new drug on people with Chronic Obstructive Pulmonary Disease (COPD)

What we are studying

The purpose of this study is to see if BFF MDI (PT009), and FF MDI (PT005) have an effect on the rate of COPD exacerbations (worsening of COPD symptoms). This is a research study to test investigational drugs for which the study sponsor, Pearl Therapeutics, plans to seek approval from the US Food and Drug Administration (FDA) and Regulatory Authorities which approve medicines for human use in other countries. Pearl Therapeutics is developing two investigational products for the treatment of COPD. These products are investigational because they are not approved by the US FDA or any international Regulatory Authorities for commercial use or sale. The two investigational products are: 1) an orally inhaled (breathed through the mouth) combination of budesonide and formoterol fumarate called Budesonide and Formoterol Fumarate Inhalation Aerosol Metered Dose Inhaler (also known as BFF MDI or PT009) and 2) an orally inhaled (breathed through the mouth) drug called Formoterol Fumarate Inhalation Aerosol Metered Dose Inhaler (also known as FF MDI or PT005). In this study, Ventolin® HFA will be used as a rescue inhaler throughout the study for the immediate relief of your COPD symptoms. Albuterol (salbutamol) Sulfate (Ventolin HFA Inhalation Aerosol) is approved by the U.S. FDA and Regulatory Authorities in other countries as a medication given as an inhaler to control the symptoms of COPD. Ventolin HFA is made by GlaxoSmithKline and not by Pearl Therapeutics.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 40 - 80

Eligibility Criteria

  • Diagnosed with COPD
  • Receiving on 1 or more inhaled bronchodilators as maintenance therapy for their COPD management for at least 6 weeks prior to screening
  • History of exacerbations
  • Current or former smokers
  • Willing and able to adjust current COPD therapy
  • Screening ECG; Chest X-ray; and/or CT scan must be acceptable to the Investigator
  • No current diagnosis of asthma
  • Not hospitalized due to poorly controlled COPD within 6 weeks prior to Visit 1
  • Not treatment with systemic corticosteroids and/or antibiotics within 4 weeks prior to Visit 1
  • Not pregnant; planning to become pregnant; or lactating during the study

What is involved

  • Informed Consent (once)
  • Review eligibility Criteria (3 times)
  • Verify Continued Eligibility (5 times)
  • Reversibility Testing (once)
  • Demographics and Medical/Surgical History (once)
  • Smoking Status (8 times)
  • Questionnaire CAT (once)
  • Prior/Concomitant Medications (14 times)
  • Spirometry (8 times)
  • Physical Examination (twice)
  • Vital Signs (8 times)
  • 12-Lead ECG (5 times)
  • Pregnancy Test (4 times)
  • Clinical Laboratory Testing (5 times)
  • Chest Image or MRI (once)
  • Adjust COPD Medications (twice)
  • Adverse Events/COPD Exacerbations (continuously)
  • Inhalation Device and Dose Indicator Training (3 times)
  • Study Drug Dispensing/Collection (7 times)
  • Study Drug Administration (6 times)
  • Questionnaire BDI/TDI (6 times)
  • Questionnaire SGRQ (6 times)
  • Questionnaire EQ-5D-5 (6 times)
  • Questionnaire HCRU (11 times)
  • Telephone Contact (6 times)
  • Ediary Dispensing/Collection (twice)
  • Ediary Training / Re-Training (twice if needed)
  • Ediary Review (13 times)

Compensation

$1,007 for completing all study visits. Withdrawal from the study for any reason will result in payment of each completed visit. Visit 1(screening), 2, 3, 4, 6, 9, 11, 14: $82.00. Visit 5, 7, 8, 10, 12, 13: $58.50.

Contact Information

Study Coordinator
Bob Hmieleski
Email
[email protected]
Phone
-8550
Principal Investigator
Eugene Bleecker, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.