A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

NCT00808288 | Completed Phase 2 DMC

• 1 other identifier: A7881013
• Study Type: interventional
• Target: 405
• Locations: 12 countries
• Sites: 75

Brief Summary

To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Lung Diseases, Obstructive

Keywords

COPD Respiratory Long acting beta agonist

Outcome Measures

Primary Outcomes (1)

• Change from baseline in trough FEV1

  6 week

Secondary Outcomes (6)

• Maximal and mean changes from baseline in heart rate, QTc and plasma potassium

  each visit

• Change from baseline in peak FEV1

  0-6 hours /6 weeks

• Change from baseline in trough and peak FEV6, FVC and IC

  6 weeks

• Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)

  2 and 4 weeks

• Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)

  2,4,6 weeks

Study Arms (5)

PF-00610355

EXPERIMENTAL

Drug: PF-00610355

PF- 00610355

EXPERIMENTAL

Drug: PF - 00610355

PF - 00610355

EXPERIMENTAL

Drug: PF- 00610355

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Salmeterol

ACTIVE COMPARATOR

Drug: Salmeterol

Interventions

PF-00610355 DRUG

oral, inhaled, dry powder, 600ug, OD

PF-00610355

PF- 00610355 DRUG

oral, inhaled, dry powder, 100ug, OD

PF - 00610355

Placebo DRUG

oral, inhaled, dry powder, placebo, OD

Placebo

Salmeterol DRUG

salmeterol, 50ug, BID

Salmeterol

Eligibility Criteria

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

You may qualify if:

• Post-bronchodilator FEV1/FVC ratio \<0.7 and a post-bronchodilator FEV1 of 50-80%.
• Diagnosis of moderate COPD for a minimum of 6 months.
• Stable disease for at least 1 month prior to screening

You may not qualify if:

• More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
• History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (75)

Pfizer Investigational Site

Fairhope, Alabama, 36532, United States

Location

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San Diego, California, 92120, United States

Location

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Spring Valley, California, 91978, United States

Location

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Wheat Ridge, Colorado, 80033, United States

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Daytona Beach, Florida, 32114, United States

Location

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Ormond Beach, Florida, 32174, United States

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Tampa, Florida, 33613, United States

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Trinity, Florida, 34655, United States

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Austell, Georgia, 30106, United States

Location

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Overland Park, Kansas, 66211, United States

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Overland Park, Kansas, 66212, United States

Location

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Fridley, Minnesota, 55432, United States

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Minneapolis, Minnesota, 55407, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63141, United States

Location

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Rochester, New York, 14618, United States

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Charlotte, North Carolina, 28207, United States

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Cincinnati, Ohio, 45227, United States

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Cincinnati, Ohio, 45231, United States

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Cincinnati, Ohio, 45242, United States

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Cincinnati, Ohio, 45245, United States

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Oklahoma City, Oklahoma, 73112, United States

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Lincoln, Rhode Island, 02865, United States

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Pawtucket, Rhode Island, 02860, United States

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Charleston, South Carolina, 29407, United States

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Charleston, South Carolina, 29414, United States

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Columbia, South Carolina, 29204, United States

Location

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78212, United States

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Morgantown, West Virginia, 26505, United States

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Rosario, Santa Fe Province, 2000, Argentina

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Buenos Aires, 1426, Argentina

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Buenos Aires, C1405BCH, Argentina

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Rousse, 7002, Bulgaria

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Sofia, 1431, Bulgaria

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Sofia, 1606, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Troyan Municipality, 5600, Bulgaria

Location

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Zagreb, 10000, Croatia

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Kutná Hora, 283 01, Czechia

Location

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Liberec, 460 01, Czechia

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Prague, 153 00, Czechia

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Tábor, 39001, Czechia

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Berlin, 12687, Germany

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Berlin, 14057, Germany

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Frankfurt, 60596, Germany

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Hamburg, 20354, Germany

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Kassel, 34121, Germany

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Lübeck, 23552, Germany

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Schwerin, 19055, Germany

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Wiesbaden, 65187, Germany

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Budapest, 1125, Hungary

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Debrecen, 4012, Hungary

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Szeged, 6772, Hungary

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Szombathely, 9700, Hungary

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Törökbálint, 2045, Hungary

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Lodz, 90-153, Poland

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Sopot, 81-741, Poland

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Warsaw, 04-141, Poland

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Wejherowo, 84-200, Poland

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Bojnice, 972 01, Slovakia

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Bratislava, 826 06, Slovakia

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Liptovský Hrádok, 033 01, Slovakia

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Nové Zámky, 940 01, Slovakia

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Poprad, 058 01, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Bellville, Cape Town, 7530, South Africa

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Tygerberg, Cape Town, 7505, South Africa

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Bloemfontein, Free State, 9301, South Africa

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Bloemfontein, South Africa

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Gatesville, Cape Town, 7764, South Africa

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Salt, Girona, 17190, Spain

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Pozuelo de Alarcón, Madrid, 28223, Spain

Location

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Istanbul, 34098, Turkey (Türkiye)

Location

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Izmir, 35100, Turkey (Türkiye)

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Lung Diseases, Obstructive

Interventions

N-((4'-hydroxybiphenyl-3-yl)methyl)-2-(3-(2-((-2-hydroxy-2-(4-hydroxy-3-((methylsulfonyl)amino)phenyl)ethyl)amino)-2-methylpropyl)phenyl)acetamide; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 15, 2008
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

ZA (5); CR (1); HU (5); BU (5); SL (6); TU (2); ES (2); US (30); PL (4); AR (3); CZ (4); DE (8)