A study to assess the Effects of PT001 and PT005 on specific image based parameters in subjects with moderate to severe COPD
- Conditions
- Moderate to severe Chronic obstructive pulmonary disease (COPD)MedDRA version: 20.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000015472Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-001744-11-BE
- Lead Sponsor
- Pearl Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1. Give their signed written informed consent to participate.
2. Are at least 40 years of age and no older than 80 at Visit 1.
3. A female is eligible to enter and participate in the study if she is of:
Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or
Child bearing potential, has a negative urine pregnancy test at Visit 1, and agrees to one of the following acceptable contraceptive methods used consistently and correctly as outlined below (ie, in accordance with the approved product label and the instructions of the physician for the duration of the study) from Visit 1 (Screening) until 14 days after Visit 5.:
- Complete abstinence from intercourse; or
- Implants of levonorgestrel inserted for at least 1 month prior to the study drug administration but not beyond the third successive year following insertion; or
- Injectable progestogen administered for at least 1 month prior to study drug administration; or
- Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study drug administration; or
- Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
- An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
- Estrogenic vaginal ring; or
- Percutaneous contraceptive patches.
4. A Male is eligible to enter and participate in the study if he is willing not to father a child during the study.
5. COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) (Celli, 2004) characterized by: Airflow limitation that is not fully reversible. Progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.
6. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking. [Number of pack-years = (number of cigarettes per day / 20) x number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years)].
7. Severity of Disease: Subjects with an established clinical history of COPD and severity defined as:
- At Visit 1 pre-bronchodilator FEV1/FVC ratio of <0.70.
- At Visit 1 post-bronchodilator FEV1 must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.
8. Stability criteria:
At Visit 4 if the pre-dose -60 minute FEV1 value is outside of the ±20% range compared to the average (-30 and -60 minute) pre-dose FEV1 value of Visit 2, the visit may be rescheduled at the Investigator’s discretion, or the subject may be discontinued.
9. Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.
10. Screening clinical laboratory tests must be acceptable to the Investigator.
11. Screening ECG must be acceptable to the Investigator.
12. Chest X-ray or CT-scan of the chest/lungs within 6 months prior to Visit 1 must be acceptable to the Investigator. Subjects who have a chest X-ray (or CT scan) that reveals clinically significant abnormalities not believed to b
Due to the extended exclusion criteria in this study the provided characters in this box are not sufficient. Please refer to protocol section 5: STUDY POPULATION SELECTION AND WITHDRAWAL CRITERIA for the full list of the exclusion criteria (page 42, section 5.2: Exclusion Criteria)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this trial is to assess the effect of treatment with GP MDI, twice daily (BID) and FF MDI, twice daily (BID) on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after two weeks treatment.;Secondary Objective: The secondary study objective is to assess the effects of GP MDI and FF MDI on various Functional Respiratory Imaging (FRI) parameters and to assess the effects of GP MDI and FF MDI on pulmonary function test (PFT) parameters. <br>;Primary end point(s): FRI Parameters:<br>• Specific airway volume (siVaw)<br>• Specific airway resistance (siRaw)<br>;Timepoint(s) of evaluation of this end point: Visit 2, 3, 4, and visit 5.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): FRI Parameters:<br>• Airway volume (iVaw)<br>• Airway resistance (iRaw)<br> <br>Spirometry Parameters:<br>• Forced expiratory volume in one second (FEV1)<br><br>Body Plethysmography Parameters:<br>• FRC<br><br>;Timepoint(s) of evaluation of this end point: Visit 2, 3, 4, and visit 5.