24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003 and Placebo MDI

• ClinicalTrials.gov Identifier: NCT02347085
• Recruitment Status: Completed
• First Posted: January 27, 2015
• Results First Posted: April 19, 2017
• Last Update Posted: July 19, 2018
• Sponsor: Pearl Therapeutics, Inc.
• Information provided by (Responsible Party): Pearl Therapeutics, Inc.

Study Description

Brief Summary:

Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003 and Placebo MDI

Condition or disease	Intervention/treatment	Phase
COPD	Drug: GFF MDI (PT003); Drug: Placebo MDI	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Phase IIIb, Two-period, Two-treatment Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects With Moderate to Very Severe COPD After 4 Weeks of Treatment With PT003 and Placebo MDI
• Actual Study Start Date: February 1, 2015
• Actual Primary Completion Date: June 1, 2015
• Actual Study Completion Date: June 1, 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: GFF MDI (PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)	Drug: GFF MDI (PT003); Other Name: Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
Placebo Comparator: Placebo MDI; Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol	Drug: Placebo MDI; Other Name: Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol

Outcome Measures

Primary Outcome Measures :

1. FEV1 AUC0-24 on Day 29 [ Time Frame: Day 29 ]
   Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC)0-24 on Day 29

Secondary Outcome Measures :

1. FEV1 AUC12-24 on Day 29 [ Time Frame: Day 29 ]
   FEV1 AUC12-24 on Day 29
2. FEV1 AUC0-12 on Day 29 [ Time Frame: Day 29 ]
   FEV1 AUC0-12 on Day 29
3. Peak Change From Baseline in FEV1 on Day 29 [ Time Frame: Day 29 ]
   Peak Change From Baseline in FEV1 following evening Dose on Day 29
4. Peak Change From Baseline in FEV1 on Day 29 [ Time Frame: Day 29 ]
   Peak Change From Baseline in FEV1 following the morning dose on Day 29
5. Morning Pre-Dose Trough FEV1 on Day 29 [ Time Frame: Day 29 ]
   Morning Pre-Dose Trough FEV on Day 29
6. Morning Pre-Dose Trough FEV1 on Day 30 [ Time Frame: Day 30 ]
   Morning Pre-Dose Trough FEV1 on Day 30
7. Peak Change From Baseline in Inspiratory Capacity (IC) Following the Evening Dose on Day 29 [ Time Frame: Day 29 ]
   Peak Change from Baseline in Inspiratory Capacity (IC) following the evening dose on Day 29
8. Peak Change From Baseline in IC Following the Morning Dose on Day 29 [ Time Frame: Day 29 ]
   Peak Change from Baseline in IC following the morning dose on Day 29

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• At least 40 years of age and no older than 80 at Screening
• Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit
• Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
• Current or former smokers with a history of at least 10 pack-years of cigarette smoking
• Pre- and post-bronchodilator FEV1/FVC ratio of <0.70
• Post-bronchodilator FEV1 must be <80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥750 mL if FEV1 <30% of predicted normal value

Exclusion Criteria:

• Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
• Women who are pregnant or lactating
• Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma
• Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening or during the Screening Period
• Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period
• Subjects who have clinically significant uncontrolled hypertension.
• Subjects who have cancer that has not been in complete remission for at least five years
• Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing
• 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 open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible
• Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study
• Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator

Contacts and Locations

Sponsors and Collaborators

Pearl Therapeutics, Inc.

Investigators

• Study Chair: Colin Reisner, MD; Pearl Therapeutics

More Information

Additional Information:

Redacted Protocol 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reisner C, Gottschlich G, Fakih F, Koser A, Krainson J, Delacruz L, Arora S, Feldman G, Pudi K, Siddiqui S, Orevillo C, Maes A, St Rose E, Martin U. 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD. Respir Res. 2017 Aug 18;18(1):157. doi: 10.1186/s12931-017-0636-4.

• Responsible Party: Pearl Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02347085
• Other Study ID Numbers: PT003012
• First Posted: January 27, 2015
• Results First Posted: April 19, 2017
• Last Update Posted: July 19, 2018
• Last Verified: June 2018

Additional relevant MeSH terms:

Glycopyrrolate; Formoterol Fumarate; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adjuvants, Anesthesia; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents