Overview

This trial is active, not recruiting.

Condition asthma
Treatments glycopyrronium mdi, serevent diskus 50 μg, placebo
Phase phase 2
Sponsor Pearl Therapeutics, Inc.
Start date April 2015
End date April 2016
Trial size 249 participants
Trial identifier NCT02433834, PT001101-00

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
GP MDI (PT001) 28.8 μg
glycopyrronium mdi
GP MDI
(Experimental)
GP MDI (PT001) 14.4 μg
glycopyrronium mdi
GP MDI
(Experimental)
GP MDI (PT001) 7.2 μg
glycopyrronium mdi
GP MDI
(Experimental)
GP MDI (PT001) 3.6 μg
glycopyrronium mdi
GP MDI
(Experimental)
GP MDI (PT001) 1.9 μg
glycopyrronium mdi
GP MDI
(Placebo Comparator)
Placebo
placebo
(Active Comparator)
Serevent® Diskus® 50 μg per inhalation
serevent diskus 50 μg

Primary Outcomes

Measure
Primary Efficacy Endpoint (Peak change from baseline in FEV1)
time frame: Peak change from baseline in FEV1 within 3 hours post-dosing on Day 15

Secondary Outcomes

Measure
Secondary Efficacy Endpoints: (Change from baseline in morning pre-dose trough FEV1)
time frame: Change from baseline in morning pre-dose trough FEV1 on Day 15
Secondary Efficacy Endpoints: (Forced expiratory volume)
time frame: Forced expiratory volume in 1 second area under the curve from time 0 to 3 hours on Day 15
Secondary Efficacy Endpoints: (Change from baseline in average daily pre-dose peak expiratory flow rate (PEFR)
time frame: Change from baseline in average daily pre-dose peak expiratory flow rate (PEFR) over 14 days
Secondary Efficacy Endpoints: (Change from baseline in average daily post-dose PEFR)
time frame: Change from baseline in average daily post-dose PEFR over 14 days
Secondary Efficacy Endpoints: Change from baseline in average daily rescue medication use
time frame: Change from baseline in average daily rescue medication use over 14 days
Secondary Efficacy Endpoints: Change from baseline in Asthma Control Questionnaire-5
time frame: Change from baseline in Asthma Control Questionnaire-5 on Day 15
Safety Endpoints Adverse Events
time frame: Adverse Events up to 24 weeks (from Visit 1 Screening to Follow up phone contact)
Safety Endpoints 12-Lead electrocardiograms
time frame: 12-Lead electrocardiograms up to 22 weeks (from Visit 1 Screening to the final visit)
Safety Endpoints Clinical laboratory testing
time frame: Clinical laboratory testing up to 22 weeks (from Visit 1 Screening to the final visit)
Safety Endpoints Vital sign measurements
time frame: Vital sign measurements up to 22 weeks (from Visit 1 Screening to the final visit)

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: 1. Give their signed written informed consent to participate 2. Males and females ranging in age between 18 to 70 years, inclusive, before Screening (Visit 1a) 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 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 4. Asthma History: Have a diagnosis of intermittent asthma or mild to moderate persistent asthma, diagnosed at least 6 months prior to Screening (Visit 1a) 5. 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) 6. Pulmonary Function: Must have a pre-bronchodilator FEV1 ≥60% and ≤90% of predicted normal value at Visit 1a/b and Visit 2a/b 7. Asthma Maintenance Therapy: For those subjects receiving asthma maintenance therapy, they must be on a stable dose of ICS or non-ICS therapy (eg., LTRA) for at least 4 weeks prior to Screening (Visit 1a). 8. Results of clinical laboratory tests conducted at Screening (Visit 1a) must be acceptable to the Investigator. Exclusion Criteria: 1. 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). 2. 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). 3. Seasonal or Exercise-Induced Asthma Alone: Subjects with only seasonal or exerciseinduced asthma are excluded from participation. 4. 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. 5. 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. 6. 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. 7. Inhaled Anticholinergic Use: Subjects must not have used inhaled anticholinergics for at least the 2 weeks prior to Screening (Visit 1a). 8. Pregnant women or nursing mothers 9. 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). 10. Uncontrolled Hypertension: Subjects who, in the opinion of the Investigator, have clinically significant uncontrolled hypertension. 11. 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. 12. 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. 13. 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. 14. Cancer: Subjects who have cancer that has not been in complete remission for at least 5 years. Note: Subjects with squamous cell carcinoma and basal cell carcinoma of the skin that have been resected for cure are not considered exclusionary. Subjects with localized prostate cancer that in the opinion of the Investigator, has been adequately worked up, is clinically controlled, and the subject's participation in the study would not represent a safety concern, are eligible. 15. Drug Allergy: Subjects who have a history of hypersensitivity to lactose, milk proteins, or to any component of the MDI or dry powder inhaler (DPI) 16. Substance Abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2-year period prior to Screening (Visit 1a). 17. Cardiac Conditions/Disease: Subjects with documented myocardial infarction within a year from the Screening (Visit 1a) are to be excluded. Subjects with a recent history of acute coronary syndrome, or who have undergone percutaneous coronary intervention or coronary artery bypass graft within 3 months of Screening (Visit 1a) are to be excluded.

Additional Information

Official title A Randomized, Double-Blind, Chronic-Dosing (14 Days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of PT001 Relative to Placebo Metered Dose Inhaler and Open-Label Serevent® Diskus® in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Pearl Therapeutics, Inc..