NCT00430300

Brief Summary

Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
5 countries

22 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
5 years until next milestone

Results Posted

Study results publicly available

July 8, 2013

Completed
Last Updated

July 8, 2013

Status Verified

May 1, 2013

Enrollment Period

1.5 years

First QC Date

January 30, 2007

Results QC Date

May 17, 2013

Last Update Submit

May 17, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Dry Powder for InhalationChronic Obstructive Pulmonary DiseaseLung Function testing

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6

    FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.

    Pre-dose at Baseline, Week 6

Secondary Outcomes (18)

  • Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8

    Pre-dose at Baseline, Week 2, 4, 8

  • Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8

    Pre-dose at Baseline, Week 2, 4, 6, 8

  • Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8

    Pre-dose at Baseline, Week 2, 4, 6, 8

  • Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8

    Pre-dose at Baseline, Week 2, 4, 6, 8

  • Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6

    15 to 30 minutes post-dose at Baseline, Week 2, 4, 6

  • +13 more secondary outcomes

Other Outcomes (5)

  • Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6

    Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4

  • Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6

    Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 1, 6; 3-hour post-dose on Week 0, 2, 4

  • Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (QT, QTc, QTcB, QTcF, QRS, RR and PR) at Week 0, 1, 2, 4, 6, and 8

    Baseline (pre-dose at Week 0); Pre-dose and 3-hour post-dose on Week 6; 3-hour post-dose on Week 0, 1, 2, 4; Week 8 (follow-up)

  • +2 more other outcomes

Study Arms (2)

150mcg, 450mcg or 1350mcg

EXPERIMENTAL

Active treatment given BID via a double pin monodose capsule inhaler device

Drug: UK-432,097

Placebo

PLACEBO COMPARATOR

Placebo treatment given BID via a single pin monodose inhaler device

Drug: Placebo

Interventions

UK-432,097DRUG

Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.

150mcg, 450mcg or 1350mcg
PlaceboDRUG

Capsules containing 100% lactose administered BID using an atomizer device

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease
  • Patients must have a smoking history of at least 10 pack-years
  • Patients must have stable disease for at least 1 month prior to screening.

You may not qualify if:

  • More than 2 exacerbations of COPD in the preceding year
  • History of a lower respiratory tract infection or significant disease instability during the month proceding screening or during the time between screen and randomization.
  • History or presence of respiratory failure, cor pulmonale or right ventricular failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Pfizer Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

Pfizer Investigational Site

Glebe, New South Wales, 2037, Australia

Location

Pfizer Investigational Site

Daw Park, South Australia, 5041, Australia

Location

Pfizer Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

Pfizer Investigational Site

Calgary, Alberta, T1Y 6J4, Canada

Location

Pfizer Investigational Site

Red Deer, Alberta, T4N 6V7, Canada

Location

Pfizer Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Pfizer Investigational Site

Québec, Quebec, G1V 4G5, Canada

Location

Pfizer Investigational Site

Trois-Rivières, Quebec, G8T 7A1, Canada

Location

Pfizer Investigational Site

Almelo, 7609 PP, Netherlands

Location

Pfizer Investigational Site

Eindhoven, 5623 EJ, Netherlands

Location

Pfizer Investigational Site

Zuthpen, 7207 BA, Netherlands

Location

Pfizer Investigational Site

Bydgoszcz, Poland, 85-326, Poland

Location

Pfizer Investigational Site

Gdansk, Poland, 80-952, Poland

Location

Pfizer Investigational Site

Warsaw, Poland, 01-138, Poland

Location

Pfizer Investigational Site

Lodz, 90-153, Poland

Location

Pfizer Investigational Site

Chertsey, Surrey, KT16 0PZ, United Kingdom

Location

Pfizer Investigational Site

Leicester, LE3 9QP, United Kingdom

Location

Pfizer Investigational Site

London, E2 9ZY, United Kingdom

Location

Pfizer Investigational Site

Manchester, M23 QZ, United Kingdom

Location

Pfizer Investigational Site

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Pfizer Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was terminated prematurely due to futility based on results of interim analysis.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

January 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

July 8, 2013

Results First Posted

July 8, 2013

Record last verified: 2013-05

Locations

GB(6)NL(3)PL(4)CA(5)AU(4)