Chronic Dosing Cross-Over Study to Assess the Efficacy and Safety of Glycopyrronium (PT001) in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

NCT02433834 | Completed Phase 2 Results

• 1 other identifier: PT001101-00
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 43

Brief Summary

A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Peak Change From Baseline in FEV1 Within 3 Hours Post-dosing on Day 15

  Forced Expiratory Volume in 1 second (FEV1) within 3 hours post-dosing on Day 15

  From Day 1 to Within 3 hours post dosing on Day 15 in each of 5 treatment periods

Secondary Outcomes (6)

• Change From Baseline in Morning Pre-dose Trough FEV1 on Day 15

  Day 1-Day 15 in each of 5 treatment periods

• FEV1 AUC0-3 on Day 15

  Day 1-Day 15 in each of 5 treatment periods

• Change From Baseline in Average Daily Pre-dose PEFR Over 14 Days

  Day 1-Day 15 in each of 5 treatment periods

• Change From Baseline in Average Daily Post-dose PEFR Over 14 Days

  Day 1-Day 15 in each of 5 treatment periods

• Change From Baseline in Average Daily Rescue Medication Use Over 14 Days

  Day 1-Day 15 in each of 5 treatment periods

Study Arms (7)

GP MDI 28.8 μg

EXPERIMENTAL

GP MDI (PT001) 28.8 μg

Drug: Glycopyrronium MDI

GP MDI 14.4 μg

EXPERIMENTAL

GP MDI (PT001) 14.4 μg

Drug: Glycopyrronium MDI

GP MDI 7.2 μg

EXPERIMENTAL

GP MDI (PT001) 7.2 μg

Drug: Glycopyrronium MDI

GP MDI 3.6 μg per

EXPERIMENTAL

GP MDI (PT001) 3.6 μg

Drug: Glycopyrronium MDI

GP MDI 1.9 μg

EXPERIMENTAL

GP MDI (PT001) 1.9 μg

Drug: Glycopyrronium MDI

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Serevent® Diskus® 50 μg per inhalation

ACTIVE COMPARATOR

Serevent® Diskus® 50 μg per inhalation

Drug: Serevent Diskus 50 μg

Interventions

Glycopyrronium MDI DRUG

GP MDI

GP MDI 1.9 μg; GP MDI 14.4 μg; GP MDI 28.8 μg; GP MDI 3.6 μg per; GP MDI 7.2 μg

Serevent Diskus 50 μg DRUG

Serevent® Diskus® 50 μg per inhalation

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Give their signed written informed consent to participate
• Males and females ranging in age between 18 to 70 years, inclusive, before Screening (Visit 1a)
• 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 serum pregnancy test at Screening (Visit 1a), and agrees to 1 of the following acceptable contraceptive methods used consistently and correctly (ie., in accordance with the approved product label and the instructions of the physician for the duration of the study, from Screening \[Visit 1a\] until 14 days after Visit 12):
• 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 and administered for 1 month following study completion; 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 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
• Asthma History: Have a diagnosis of intermittent asthma or mild to moderate persistent asthma, diagnosed at least 6 months prior to Screening (Visit 1a)
• Reversibility: Diagnosis of asthma confirmed at Screening (Visits 1 and 2) with demonstration of reversibility to a bronchodilator defined as an FEV1 increase of at least 12% and at least 200 mL, 30 to 60 minutes after the inhalation of 4 puffs of salbutamol/albuterol (Ventolin HFA)
• Pulmonary Function: Must have a pre-bronchodilator FEV1 ≥60% and ≤90% of predicted normal value at Visit 1a/b and Visit 2a/b

You may not qualify if:

• Life-Threatening Asthma: A subject must not have life-threatening asthma. Lifethreatening asthma is defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within the 12 months prior to Visit 1a (Screening).
• Worsening Asthma: A subject must not have experienced a worsening of asthma that involved an emergency department visit, hospitalization, or use of oral/parenteral corticosteroids within 6 weeks of Screening (Visit 1a).
• Seasonal or Exercise-Induced Asthma Alone: Subjects with only seasonal or exerciseinduced asthma are excluded from participation.
• Concurrent Respiratory Disease: A subject must not have current evidence or diagnosis of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, COPD, or other respiratory abnormalities other than asthma.
• Concurrent Conditions/Diseases: A subject with historical or current evidence of any clinically significant, or comorbid or uncontrolled condition or disease state that, in the opinion of the Investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
• Smoking History: Current smokers or former smokers who have stopped smoking within 6 months prior to enrollment or with a \>10 pack year history of cigarettes, cigars, or pipe smoking. E-cigarettes and inhaled marijuana should be treated in the same manner as tobacco products.
• Inhaled Anticholinergic Use: Subjects must not have used inhaled anticholinergics for at least the 2 weeks prior to Screening (Visit 1a).
• Pregnant women or nursing mothers
• Respiratory Tract Infection: Subjects who have had a respiratory tract infection within 6 weeks prior to Screening (Visit 1a). Subjects who develop a respiratory tract infection during the Screening Period must discontinue from the trial, but will be permitted to reenroll at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
• Uncontrolled Hypertension: Subjects who, in the opinion of the Investigator, have clinically significant uncontrolled hypertension.
• Liver Function: Subjects with abnormal liver function tests defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or total bilirubin ≥1.5 times the upper limit of normal on repeat testing.
• Renal: a. Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator (if treated and asymptomatic, the subject is eligible for enrollment). Subjects with a trans-urethral resection of prostate or full resection of the prostate within 6 months prior to Visit 1a are excluded from the study.
• b. Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator. c. Subjects with a calculated creatinine clearance ≤30 mL/minute using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \[Levey, 2009\] at Visit 1a and on repeat testing prior to Visit 3. Note: Subjects with overactive bladder syndrome treated with oral anticholinergics that have been on treatment for at least one month are allowed in the study.
• Glaucoma: Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of glaucoma (non-angle closure), that in the opinion of the Investigator, has not been adequately treated will also be excluded. Subjects with previously diagnosed glaucoma who have intraocular pressure controlled with medication(s) are eligible. All medications approved for control of intraocular pressures are allowed including topical ophthalmic non-selective β-blockers such as betaxolol, carteolol, levobunolol, metipranolol, or timolol.
• Cancer: Subjects who have cancer that has not been in complete remission for at least 5 years.

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (43)

Pearl Therapeutics Inc.

Birmingham, Alabama, 35209, United States

Location

Pearl Therapeutics Inc.

Anaheim, California, 92801, United States

Location

Pearl Therapeutics Inc.

Bakersfield, California, 93301, United States

Location

Pearl Therapeutics Inc.

Cerritos, California, 90703, United States

Location

Pearl Therapeutics Inc.

Los Angeles, California, 90017, United States

Location

Pearl Therapeutics Inc.

Los Angeles, California, 90025, United States

Location

Pearl Therapeutics Inc.

Los Angeles, California, 90036, United States

Location

Pearl Therapeutics Inc.

Los Angeles, California, 90048, United States

Location

Pearl Therapeutics Inc.

Quartz Hill, California, 90036, United States

Location

Pearl Therapeutics Inc.

Rancho Mirage, California, 92270, United States

Location

Pearl Therapeutics Inc.

Rolling Hills Estates, California, 90274, United States

Location

Pearl Therapeutics Inc.

Stockton, California, 95207, United States

Location

Pearl Therapeutics Inc.

Colorado Springs, Colorado, 80907, United States

Location

Pearl Therapeutics Inc.

Kissimmee, Florida, 34744, United States

Location

Pearl Therapeutics Inc.

Miami, Florida, 33126, United States

Location

Pearl Therapeutics Inc.

Miami, Florida, 33186, United States

Location

Pearl Therapeutics Inc.

Ormond Beach, Florida, 32174, United States

Location

Pearl Therapeutics Inc.

Evanston, Illinois, 60201, United States

Location

Pearl Therapeutics Inc.

Iowa City, Iowa, 52240, United States

Location

Pearl Therapeutics Inc.

Fall River, Massachusetts, 02720, United States

Location

Pearl Therapeutics Inc.

North Dartmouth, Massachusetts, 02747, United States

Location

Pearl Therapeutics Inc.

St Louis, Missouri, 63141, United States

Location

Pearl Therapeutics Inc.

Omaha, Nebraska, 68114, United States

Location

Pearl Therapeutics Inc.

Skillman, New Jersey, 08558, United States

Location

Pearl Therapeutics Inc.

Verona, New Jersey, 07044, United States

Location

Pearl Therapeutics Inc.

Asheville, North Carolina, 28801, United States

Location

Pearl Therapeutics Inc.

Cornelius, North Carolina, 28031, United States

Location

Pearl Therapeutics Inc.

Gastonia, North Carolina, 28054, United States

Location

Pearl Therapeutics Inc.

Monroe, North Carolina, 28112, United States

Location

Pearl Therapeutics Inc.

Raleigh, North Carolina, 28054, United States

Location

Pearl Therapeutics Inc.

Shelby, North Carolina, 28152, United States

Location

Pearl Therapeutics Inc.

Grove City, Ohio, 43123, United States

Location

Pearl Therapeutics Inc.

Middleburg Heights, Ohio, 44130, United States

Location

Pearl Therapeutics Inc.

Lake Oswego, Oregon, 97035, United States

Location

Pearl Therapeutics Inc.

Medford, Oregon, 97504, United States

Location

Pearl Therapeutics Inc.

Columbia, South Carolina, 29201, United States

Location

Pearl Therapeutics Inc.

Dallas, Texas, 75254, United States

Location

Pearl Therapeutics Inc.

El Paso, Texas, 79903, United States

Location

Pearl Therapeutics Inc.

Killeen, Texas, 76543, United States

Location

Pearl Therapeutics Inc.

McKinney, Texas, 75070, United States

Location

Pearl Therapeutics Inc.

New Braunfels, Texas, 78130, United States

Location

Pearl Therapeutics Inc.

San Antonio, Texas, 78229, United States

Location

Pearl Therapeutics Inc.

Waco, Texas, 76712, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Paul Dorinsky, MD, FCCP
• Organization: Pearl Therapeutics, Inc.

pdorinsky@pearltherapeutics.com

650-305-2600

Study Officials

• Shahid Siddiqui

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2015
• First Posted: May 5, 2015
• Study Start: May 27, 2015
• Primary Completion: March 26, 2016
• Study Completion: March 26, 2016
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-05

Locations

US (43)