A PHASE 2B, PARALLEL, DOUBLE BLIND, DOUBLE DUMMY, ACTIVE COMPARATOR AND PLACEBO CONTROLLED STUDY TO INVESTIGATE THE SAFETY, TOLERATION AND EFFICACY OF 6-WEEK QD ADMINISTRATION OF PF-00610355 CRC-749 DPI IN PATIENTS WITH MODERATE COPD

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2010
INTERVENTION: Product Code: PF‐00610355 Pharmaceutical Form: Inhalation powder CAS Number: 862541‐45‐5 Current Sponsor code: PF‐00610355 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Trade Name: Serevent Accuhaler™ Pharmaceutical Form: Inhalation powder CAS Number: 89365‐50‐4 Current Sponsor code: Salmeterol Other descriptive name: 2‐(hydroxymethyl)‐4‐{1‐hydroxy‐2‐[6‐(4‐phenylbutoxy) hexylamino]ethyl}phenol Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Product Code: PF‐00610355 Pharmaceutical Form: Inhalation powder CAS Number: 862541‐45‐5 Current Sponsor code: PF‐00610355 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 300‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use Product Code: PF‐00610355 Pharmaceutical Form: Inhalation powder CAS Number: 862541‐45‐5 Current Sponsor code: PF‐00610355 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 600‐ Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use CONDITION: Chronic Obstructive Pulmonary Disease ; MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD PRIMARY OUTCOME: Main Objective: To test all doses (100, 300 and 600 µg QD) of PF‐00610355 and salmeterol 50 µg (BID) for superior efficacy on trough FEV1 vs placebo at Week 6. Primary end point(s): Change from baseline in trough FEV1 at Week 6. Secondary Objective: To test all doses of PF‐00610355 and salmeterol 50 µg for superior efficacy on peak FEV1 vs placebo at Day 1 and Week 6.; To characterise dose/response vs placebo at Week 6.; To test all doses of PF‐00610355 and salmeterol for superior efficacy on QOL, COPD; symptoms, and dyspnea and rescue medication use vs placebo.; To test all doses and salmeterol for superior efficacy vs placebo at Weeks 2 and 4.; To investigate the dose response relationship of PF‐00610355 vs ß2‐mediated extra; pulmonary effects in COPD patients, specifically: heart rate, blood pressure, QTc,; arrhythmias and plasma potassium. INCLUSION CRITERIA: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 2. Male or female patients between, and including, the ages of 40 and 80 years. Females may be of either childbearing or non‐child bearing potential. Females of non‐childbearing potential will be defined as: ‐ Females over the age of 60 years. ‐ Females who are 40‐60 years of age who have been amenorrheic for at least 2 years and who have a serum FSH level >30 IU/L in the absence of hormone replacement therapy, or ‐ Females with a documented hysterectomy. All females of childbearing potential may be included provided they ar
Epistemonikos ID: 6b0b9d68e1e5c31026bd8d312c6e2f2baaec0cde
First added on: Jul 27, 2021