To Assess the Efficacy and Safety of PT010 Compared to PT009 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

NCT03081247 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: PT010017
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)

  Week 12

Secondary Outcomes (7)

• Change from baseline in morning pre-dose trough FEV1

  Week 12

• Peak change from baseline in inspiratory capacity

  Week 12

• Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)

  Week 12

• Time to first clinically important deterioration (CID) in COPD

  12 weeks

• Change from baseline in average daily rescue Ventolin HFA use

  12 weeks

Study Arms (2)

BGF 320/14.4/9.6 µg MDI BID

EXPERIMENTAL

Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)

Drug: BGF 320/14.4/9.6 µg MDI

BFF 320/9.6 µg MDI BID

EXPERIMENTAL

Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

Drug: BFF 320/9.6 µg

Interventions

BGF 320/14.4/9.6 µg MDI DRUG

Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)

Also known as: PT010

BGF 320/14.4/9.6 µg MDI BID

BFF 320/9.6 µg DRUG

Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)

Also known as: PT009

BFF 320/9.6 µg MDI BID

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Subjects with an established clinical history of COPD
• Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be \<0.70 and FEV1 must be \<80% predicted normal value
• All subjects must have been on 2 or more inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening
• Current or former smokers with a history of at least 10 pack-years of cigarette smoking
• Women of Non-childbearing potential
• Women of childbearing potential and sexually active agree to prevent pregnancy by using acceptable contraceptive methods consistently

You may not qualify if:

• Significant diseases or conditions other than COPD, 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, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception
• Current diagnosis of asthma
• Uncontrolled sleep apnea
• Other Serious Respiratory Disorders
• Hospitalized due to poorly controlled COPD within 6 weeks
• Poorly Controlled COPD
• Immune deficiency and/or severe neurological disorders affecting control of the upper airway
• Hypersensitivity to β2-agonists, corticosteroids, or muscarinic anticholinergics

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Colin Reisner, MD

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 16, 2017
• Study Start: April 16, 2018
• Primary Completion: December 7, 2018
• Study Completion: December 7, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share