A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

Chronic Obstructive Pulmonary Disorder Clinical Trial

Official title:

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727660
• Other study ID #: PT009003
• Status: Completed
• Phase: Phase 3
• Start date: April 29, 2016
• Est. completion date: April 4, 2018

Study information

• Verified date: August 2019
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Description:

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1876
• Est. completion date: April 4, 2018
• Est. primary completion date: April 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Give their signed written informed consent to participate

2. At least 40 years of age and no older than 80 years of age

3. COPD patients who are symptomatic

4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

5. Must have a documented history of COPD exacerbations

Exclusion Criteria:

1. Current diagnosis of asthma

2. COPD due to a1-Antitrypsin Deficiency

3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.

4. Long-term-oxygen therapy (= 15 hours a day).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disorder
• Lung Diseases

Intervention

Drug:
• BFF MDI (PT009) 320/9.6 µg
Blinded Treatment
• BFF MDI (PT009) 160/9.6 µg
Blinded Treatment
• FF MDI (PT005) 9.6 µg
Blinded Treatment

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Ciudad Autónoma de Buenos Aire
Argentina	Research Site	Ciudad Autonomade Buenos Aires
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Concepción del Uruguay
Argentina	Research Site	Córdoba
Argentina	Research Site	Florencio Varela
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Mendoza
Argentina	Research Site	Nueve de julio
Argentina	Research Site	Ranelagh
Argentina	Research Site	Rosario
Argentina	Research Site	San Fernando
Argentina	Research Site	San Miguel de Tucuman
Austria	Research Site	Bludenz
Austria	Research Site	Feldbach
Austria	Research Site	Hallein
Austria	Research Site	Linz
Belgium	Research Site	Brussels
Belgium	Research Site	Erpent
Belgium	Research Site	Gilly
Belgium	Research Site	Jambes
Belgium	Research Site	Liège
Belgium	Research Site	Roeselare
Brazil	Research Site	Botucatu
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Santo Andre
Brazil	Research Site	Sao Bernardo do Campo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	Sorocaba
Brazil	Research Site	Uberlandia
Brazil	Research Site	Vitória
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	St Charles Borromee	Quebec
Canada	Research Site	Trois-Rivières	Quebec
Canada	Research Site	Windsor	Ontario
Canada	Research Site	Windsor	Ontario
Chile	Research Site	Curico
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Talca
Chile	Research Site	Talcahuano
Denmark	Research Site	Aarhus N
Denmark	Research Site	Ålborg
Denmark	Research Site	Hvidovre
Denmark	Research Site	København NV
Denmark	Research Site	Kolding
Denmark	Research Site	Odense C
Denmark	Research Site	Roskilde
Denmark	Research Site	Silkeborg
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Cottbus
Germany	Research Site	Frankfurt
Germany	Research Site	Köln
Germany	Research Site	Leipzig
Germany	Research Site	Lübeck
Germany	Research Site	Rodgau-Dudenhofen
Italy	Research Site	Bari
Italy	Research Site	Catania
Italy	Research Site	Ferrara
Italy	Research Site	Legnago
Italy	Research Site	Monza
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Pavia
Italy	Research Site	Riccione
Italy	Research Site	Rimini
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Sassari
Mexico	Research Site	Cdmx
Mexico	Research Site	Durango
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara
Mexico	Research Site	Minatitlán
Mexico	Research Site	Monterrey
Mexico	Research Site	Sonora
Mexico	Research Site	Villahermosa
Norway	Research Site	Arendal
Norway	Research Site	Hønefoss
Norway	Research Site	Kråkeroy
Norway	Research Site	Stavanger
Norway	Research Site	Svelvik
Norway	Research Site	Trondheim
Peru	Research Site	Chancay
Peru	Research Site	Cusco
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Piura
Puerto Rico	Research Site	Ponce
Puerto Rico	Research Site	San Juan
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Omsk
Russian Federation	Research Site	Penza
Russian Federation	Research Site	Perm
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	StPetersburg
Russian Federation	Research Site	Ulyanovsk
South Africa	Research Site	Bloemfontein
South Africa	Research Site	Cape Town
South Africa	Research Site	Cape Town
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Johannesburg
South Africa	Research Site	Lenasia Ext8
South Africa	Research Site	Mowbray
South Africa	Research Site	Parow
South Africa	Research Site	Pretoria
South Africa	Research Site	Stanger
Spain	Research Site	Alicante
Spain	Research Site	Alzira (Valencia)
Spain	Research Site	Benalmádena (Málaga)
Spain	Research Site	Cáceres
Spain	Research Site	Jerez de la Frontera
Spain	Research Site	Laredo
Spain	Research Site	Loja (Granada)
Spain	Research Site	Malaga
Spain	Research Site	Marbella (Málaga)
Spain	Research Site	Palma de Mallorca
Spain	Research Site	Sagunto(Valencia)
Spain	Research Site	Sant Boi de Llobregat
Sweden	Research Site	Lund
Sweden	Research Site	Lund
Sweden	Research Site	Malmo
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Chertsey
United Kingdom	Research Site	Chester
United Kingdom	Research Site	Doncaster
United Kingdom	Research Site	Lancaster
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Wishaw
United States	Research Site	Amarillo	Texas
United States	Research Site	Anderson	South Carolina
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aurora	Illinois
United States	Research Site	Austin	Texas
United States	Research Site	Baytown	Texas
United States	Research Site	Biddeford	Maine
United States	Research Site	Boulder	Colorado
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Bronx	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Brownsburg	Indiana
United States	Research Site	Canton	Ohio
United States	Research Site	Chesterfield	Missouri
United States	Research Site	Chicago	Illinois
United States	Research Site	Chiefland	Florida
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Ohio
United States	Research Site	Costa Mesa	California
United States	Research Site	Cumberland	Rhode Island
United States	Research Site	Dacula	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Dayton	Ohio
United States	Research Site	Daytona Beach	Florida
United States	Research Site	Decatur	Georgia
United States	Research Site	Denver	Colorado
United States	Research Site	Dothan	Alabama
United States	Research Site	East Providence	Rhode Island
United States	Research Site	Edmond	Oklahoma
United States	Research Site	Evansville	Indiana
United States	Research Site	Everett	Washington
United States	Research Site	Flagstaff	Arizona
United States	Research Site	Franklin	Tennessee
United States	Research Site	Gaffney	South Carolina
United States	Research Site	Gaffney	South Carolina
United States	Research Site	Gastonia	North Carolina
United States	Research Site	Gold River	California
United States	Research Site	Hazard	Kentucky
United States	Research Site	Hialeah	Florida
United States	Research Site	Hickory	North Carolina
United States	Research Site	Hickory	North Carolina
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Iowa City	Iowa
United States	Research Site	Johnstown	Pennsylvania
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kerrville	Texas
United States	Research Site	Kissimmee	Florida
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Lancaster	South Carolina
United States	Research Site	Leesburg	Florida
United States	Research Site	Lehigh Acres	Florida
United States	Research Site	Lenoir	North Carolina
United States	Research Site	Lewisville	Texas
United States	Research Site	Lincoln	Nebraska
United States	Research Site	Lincoln	California
United States	Research Site	Long Beach	California
United States	Research Site	Lufkin	Texas
United States	Research Site	Manassas	Virginia
United States	Research Site	Marion	Ohio
United States	Research Site	McKinney	Texas
United States	Research Site	McKinney	Texas
United States	Research Site	Medford	Oregon
United States	Research Site	Merritt Island	Florida
United States	Research Site	Metairie	Louisiana
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Olathe	Kansas
United States	Research Site	Orangeburg	South Carolina
United States	Research Site	Orlando	Florida
United States	Research Site	Ormond Beach	Florida
United States	Research Site	Palo Alto	California
United States	Research Site	Peoria	Illinois
United States	Research Site	Plano	Texas
United States	Research Site	Port Arthur	Texas
United States	Research Site	Port Orange	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Reno	Nevada
United States	Research Site	Renton	Washington
United States	Research Site	Rochester	Minnesota
United States	Research Site	Rock Hill	South Carolina
United States	Research Site	Saint Charles	Missouri
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	Sarasota	Florida
United States	Research Site	Scottdale	Pennsylvania
United States	Research Site	Seneca	South Carolina
United States	Research Site	Sheffield	Alabama
United States	Research Site	Sherman	Texas
United States	Research Site	Smyrna	Tennessee
United States	Research Site	Snellville	Georgia
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Spring	Texas
United States	Research Site	Stockbridge	Georgia
United States	Research Site	Sunset	Louisiana
United States	Research Site	Syracuse	New York
United States	Research Site	Tabor City	North Carolina
United States	Research Site	Tampa	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Toms River	New Jersey
United States	Research Site	Topeka	Kansas
United States	Research Site	Upland	California
United States	Research Site	Valparaiso	Indiana
United States	Research Site	Waco	Texas
United States	Research Site	Warwick	Rhode Island
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Park	Florida
United States	Research Site	Wooster	Ohio
United States	Research Site	Wyomissing	Pennsylvania
United States	Research Site	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Denmark,  Germany,  Italy,  Mexico,  Norway,  Peru,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning Pre-dose Trough FEV1	Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12	at Week 12
Secondary	Time to First Moderate or Severe COPD Exacerbation	Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks	over 52 weeks
Secondary	Change From Baseline in Average Daily Rescue Ventolin HFA Use	Change from baseline in average daily rescue Ventolin HFA use over 12 weeks	over 12 weeks
Secondary	Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score	The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.	at Week 12

External Links

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