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AsthmaPhase 2NCT02433834

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

A Phase 2 study testing Glycopyrronium MDI and Serevent Diskus 50 μg in people with Asthma, run by Pearl Therapeutics, Inc. at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Asthma
What is being tested?
Glycopyrronium MDI and Serevent Diskus 50 μg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
43 sitesUnited States
Study dates
27 May 2015to 26 Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • 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).
  • Results of clinical laboratory tests conducted at Screening (Visit 1a) must be acceptable to the Investigator.

Who cannot join

  • 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.
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  • 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.
  • 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.
  • 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.
  • 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)
  • 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).
  • 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.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Pearl Therapeutics Inc.

    Anaheim, California, 92801

  • Pearl Therapeutics Inc.

    Asheville, North Carolina, 28801

  • Pearl Therapeutics Inc.

    Bakersfield, California, 93301

  • Pearl Therapeutics Inc.

    Birmingham, Alabama, 35209

  • Pearl Therapeutics Inc.

    Cerritos, California, 90703

  • Pearl Therapeutics Inc.

    Colorado Springs, Colorado, 80907

  • Pearl Therapeutics Inc.

    Columbia, South Carolina, 29201

  • Pearl Therapeutics Inc.

    Cornelius, North Carolina, 28031

  • Pearl Therapeutics Inc.

    Dallas, Texas, 75254

  • Pearl Therapeutics Inc.

    El Paso, Texas, 79903

  • Pearl Therapeutics Inc.

    Evanston, Illinois, 60201

  • Pearl Therapeutics Inc.

    Fall River, Massachusetts, 02720

  • Pearl Therapeutics Inc.

    Gastonia, North Carolina, 28054

  • Pearl Therapeutics Inc.

    Grove City, Ohio, 43123

  • Pearl Therapeutics Inc.

    Iowa City, Iowa, 52240

  • Pearl Therapeutics Inc.

    Killeen, Texas, 76543

  • Pearl Therapeutics Inc.

    Kissimmee, Florida, 34744

  • Pearl Therapeutics Inc.

    Lake Oswego, Oregon, 97035

  • Pearl Therapeutics Inc.

    Los Angeles, California, 90017

  • Pearl Therapeutics Inc.

    Los Angeles, California, 90025

  • Pearl Therapeutics Inc.

    Los Angeles, California, 90036

  • Pearl Therapeutics Inc.

    Los Angeles, California, 90048

  • Pearl Therapeutics Inc.

    McKinney, Texas, 75070

  • Pearl Therapeutics Inc.

    Medford, Oregon, 97504

  • Pearl Therapeutics Inc.

    Miami, Florida, 33126

  • Pearl Therapeutics Inc.

    Miami, Florida, 33186

  • Pearl Therapeutics Inc.

    Middleburg Heights, Ohio, 44130

  • Pearl Therapeutics Inc.

    Monroe, North Carolina, 28112

  • Pearl Therapeutics Inc.

    New Braunfels, Texas, 78130

  • Pearl Therapeutics Inc.

    North Dartmouth, Massachusetts, 02747

  • Pearl Therapeutics Inc.

    Omaha, Nebraska, 68114

  • Pearl Therapeutics Inc.

    Ormond Beach, Florida, 32174

  • Pearl Therapeutics Inc.

    Quartz Hill, California, 90036

  • Pearl Therapeutics Inc.

    Raleigh, North Carolina, 28054

  • Pearl Therapeutics Inc.

    Rancho Mirage, California, 92270

  • Pearl Therapeutics Inc.

    Rolling Hills Estates, California, 90274

  • Pearl Therapeutics Inc.

    San Antonio, Texas, 78229

  • Pearl Therapeutics Inc.

    Shelby, North Carolina, 28152

  • Pearl Therapeutics Inc.

    Skillman, New Jersey, 08558

  • Pearl Therapeutics Inc.

    St Louis, Missouri, 63141

  • Pearl Therapeutics Inc.

    Stockton, California, 95207

  • Pearl Therapeutics Inc.

    Verona, New Jersey, 07044

  • Pearl Therapeutics Inc.

    Waco, Texas, 76712

Other trials in United States

About this study

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

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
Being tested
Glycopyrronium MDI, Serevent Diskus 50 μg, Placebo
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glycopyrronium MDIDrug

    GP MDI

  • Serevent Diskus 50 μgDrug

  • PlaceboDrug

Study groups in NCT02433834
Study groupRoleWhat they receive
GP MDI 28.8 μgExperimentalGP MDI (PT001) 28.8 μg
Receives: Drug: Glycopyrronium MDI
GP MDI 14.4 μgExperimentalGP MDI (PT001) 14.4 μg
Receives: Drug: Glycopyrronium MDI
GP MDI 7.2 μgExperimentalGP MDI (PT001) 7.2 μg
Receives: Drug: Glycopyrronium MDI
GP MDI 3.6 μg perExperimentalGP MDI (PT001) 3.6 μg
Receives: Drug: Glycopyrronium MDI
GP MDI 1.9 μgExperimentalGP MDI (PT001) 1.9 μg
Receives: Drug: Glycopyrronium MDI
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
Serevent® Diskus® 50 μg per inhalationActive comparatorSerevent® Diskus® 50 μg per inhalation
Receives: Drug: Serevent Diskus 50 μg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (6)

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

    Change from baseline in morning pre-dose trough FEV1 on Day 15

    Measured: Day 1-Day 15 in each of 5 treatment periods

  2. FEV1 AUC0-3 on Day 15

    FEV1 AUC0-3 is the area under the curve for the change from baseline in FEV1 calculated using the trapezoidal rule. All observed data will be used with the trapezoidal rule to calculate AUC. To aid in interpretation, all AUC values will be normalized by dividing the AUC by the time from the first to the last non-missing value (typically 3 hours).

    Measured: Day 1-Day 15 in each of 5 treatment periods

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

    Change from baseline in average daily pre-dose peak expiratory flow rate (PEFR) over 14 days Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.

    Measured: Day 1-Day 15 in each of 5 treatment periods

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

    Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.

    Measured: Day 1-Day 15 in each of 5 treatment periods

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

    Daily pre-dose PEFR and daily post-dose PEFR will each be calculated as the average of the AM and PM measurements recorded for a given day. If either the AM or PM assessment is missing, only the single measurement will be used. Analyses of average daily pre-dose PEFR, average daily post-dose PEFR, and rescue Ventolin HFA usage will use the average of the non-missing daily values recorded in the subject diaries over each week and over the last week of treatment within each period.

    Measured: Day 1-Day 15 in each of 5 treatment periods

  6. Change From Baseline in Asthma Control Questionnaire (ACQ-5) on Day 15

    The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum

    Measured: Day 1-Day 15 in each of 5 treatment periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2015 (estimated)
  2. Study start27 May 2015
  3. Primary completion26 Mar 2016
  4. Study completion26 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02433834
Sponsor's protocol ID
PT001101-00
Status last verified
May 2017
First submitted
24 Apr 2015
Last updated
2 Jul 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glycopyrronium MDI and Serevent Diskus 50 μg in people with Asthma, run by Pearl Therapeutics, Inc. at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Change From Baseline in FEV1 Within 3 Hours Post-dosing on Day 15 (time frame: From Day 1 to Within 3 hours post dosing on Day 15 in each of 5 treatment periods). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02433834.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017; AzTrials last refreshed its copy on 3 Nov 2026.

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