Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01085045 | Completed Phase 2 Results

• 1 other identifier: PT0031002
• Study Type: interventional
• Target: 118
• Locations: 3 countries
• Sites: 16

Brief Summary

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• FEV1 AUC 0-12 on Day 7

  Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration

  "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7

Secondary Outcomes (12)

• Peak Change From BL in FEV1 on Day 1

  Day 1

• Peak Change From BL in FEV1 on Day 7

  Day 7

• Peak Change From BL in Inspiratory Capacity on Day 1

  Day 1

• Peak Change From BL IC on Day 7

  Day 7

• Time to Onset of Action >=10% Improvement in FEV1 on Day 1

  Day 1

Study Arms (8)

Inhaled PT003 (Dose 1)

EXPERIMENTAL

PT003 MDI Dose 1

Drug: PT003 MDI

Inhaled PT003 (Dose 2)

EXPERIMENTAL

PT003 MDI Dose 2

Drug: PT003 MDI

Inhaled PT005 (Dose 1)

EXPERIMENTAL

PT005 MDI Dose 1

Drug: PT005 MDI

Inhaled PT005 (Dose 2)

EXPERIMENTAL

PT005 MDI Dose 2

Drug: PT005 MDI

Inhaled Placebo

PLACEBO COMPARATOR

Placebo MDI

Drug: Placebo MDI

Tiotropium bromide 18 μg (Spiriva Handihaler®)

ACTIVE COMPARATOR

Tiotropium Bromide inhalation powder

Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

ACTIVE COMPARATOR

Formoterol fumarate inhalation powder 12 μg

Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Inhaled PT001 (Dose 1)

EXPERIMENTAL

PT001 MDI Dose 1

Drug: PT001 MDI

Interventions

PT003 MDI DRUG

Inhaled PT003 MDI administered as two puffs BID for 7 days

Inhaled PT003 (Dose 1); Inhaled PT003 (Dose 2)

PT005 MDI DRUG

Inhaled PT005 MDI administered as two puffs BID for 7 days

Inhaled PT005 (Dose 1); Inhaled PT005 (Dose 2)

Placebo MDI DRUG

Inhaled placebo administered as two puffs BID for 7 days

Inhaled Placebo

Tiotropium bromide 18 μg (Spiriva Handihaler®) DRUG

Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days

Tiotropium bromide 18 μg (Spiriva Handihaler®)

Formoterol Fumarate 12 μg (Foradil® Aerolizer®) DRUG

Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

PT001 MDI DRUG

Inhaled PT001 MDI administered as two puffs BID for 7 days

Inhaled PT001 (Dose 1)

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 written informed consent
• years of age
• Clinical history of COPD with airflow limitation that is not fully reversible
• Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
• Current/former smokers with at least a 10 pack-year history of cigarette smoking
• A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
• A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
• Able to change COPD treatment as required by protocol

You may not qualify if:

• Women who are pregnant or lactating
• Primary diagnosis of asthma
• Alpha-1 antitrypsin deficiency as the cause of COPD
• Active pulmonary diseases
• Prior lung volume reduction surgery
• Abnormal chest X-ray (or CT scan) not due to the presence of COPD
• Hospitalized due to poorly controlled COPD within 3 months of Screening
• Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
• Cancer that has not been in complete remission for at least 5 years
• Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (16)

Clinical Research of West Florida, Inc.

Clearwater, Florida, 33765, United States

Location

American Health Research

Charlotte, North Carolina, 28207, United States

Location

Clinical Research Institute of Southern Oregon, PC

Medford, Oregon, 97504, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Austrials

Caringbah, New South Wales, 2229, Australia

Location

Woolcock

Glebe, New South Wales, 2037, Australia

Location

Austrials

Hornsby, New South Wales, 2077, Australia

Location

Austrials

Auchenflower, Queensland, 4066, Australia

Location

Q-Pharm

Herston, Queensland, 4006, Australia

Location

Respiratory Research Foundation - Burnside War Memorial Hospital

Adelaide, South Australia, Australia

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

Lung Institute of WA

Nedlands, Western Australia, 6006, Australia

Location

Greenlane Clinical Centre

Epsom, Auckland, 1051, New Zealand

Location

NZ Respiratory & Sleep Institute

Greenlane East, Auckland, 1051, New Zealand

Location

Waikato Hospital

Hamilton, Waikato Region, 3240, New Zealand

Location

P3 Research

Crofton Downs, Wellington Region, 6143, New Zealand

Location

Related Publications (1)

• Reisner C, Fabbri LM, Kerwin EM, Fogarty C, Spangenthal S, Rabe KF, Ferguson GT, Martinez FJ, Donohue JF, Darken P, St Rose E, Orevillo C, Strom S, Fischer T, Golden M, Dwivedi S. A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease. Respir Res. 2017 Jan 6;18(1):8. doi: 10.1186/s12931-016-0491-8.

  PMID: 28061907 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines

Results Point of Contact

• Title: Colin Reisner, MD, FCCP, FAAAAI
• Organization: Pearl Therapeutics, Inc

creisner@pearltherapeutics.com

650-305-2600

Study Officials

• Colin Reisner, M.D.

  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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 11, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 26, 2017
• Results First Posted: April 26, 2017

Record last verified: 2017-03

Locations

AU (8); NZ (4); US (4)