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Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UK-432,097
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Dry Powder for Inhalation, Chronic Obstructive Pulmonary Disease, Lung Function testing

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

150mcg, 450mcg or 1350mcg

Placebo

Arm Description

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

Placebo treatment given BID via a single pin monodose inhaler device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
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.
Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.
Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Change From Baseline in Post-Bronchodilator 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. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Change From Baseline in Post-Bronchodilator FEV6 at Week 6
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Change From Baseline in Post-Bronchodilator FVC at Week 6
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Change From Baseline in Post-Bronchodilator IC at Week 6
IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week.
Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
Participants were issued with rescue medication (Salbutamol MDI [100 mcg/actuation]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week.
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week.
Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.

Full Information

First Posted
January 30, 2007
Last Updated
May 17, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00430300
Brief Title
Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
Official Title
A Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group Study To Evaluate the Efficacy And Safety of UK-432,097 Dry Powder For Inhalation In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Terminated
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Dry Powder for Inhalation, Chronic Obstructive Pulmonary Disease, Lung Function testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
150mcg, 450mcg or 1350mcg
Arm Type
Experimental
Arm Description
Active treatment given BID via a double pin monodose capsule inhaler device
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo treatment given BID via a single pin monodose inhaler device
Intervention Type
Drug
Intervention Name(s)
UK-432,097
Intervention Description
Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules containing 100% lactose administered BID using an atomizer device
Primary Outcome Measure Information:
Title
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
Description
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.
Time Frame
Pre-dose at Baseline, Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
Description
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.
Time Frame
Pre-dose at Baseline, Week 2, 4, 8
Title
Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
Description
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Trough FEV6 was obtained from spirometry, performed before study treatment administration.
Time Frame
Pre-dose at Baseline, Week 2, 4, 6, 8
Title
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
Description
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was obtained from spirometry, performed before study treatment administration.
Time Frame
Pre-dose at Baseline, Week 2, 4, 6, 8
Title
Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
Description
IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Trough IC was obtained from spirometry, performed before study treatment administration.
Time Frame
Pre-dose at Baseline, Week 2, 4, 6, 8
Title
Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
Description
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Time Frame
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Title
Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
Description
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-study drug FEV6 was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Time Frame
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Title
Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
Description
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-study drug FVC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Time Frame
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Title
Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
Description
IC is the maximum amount of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-study drug IC was obtained from spirometry, performed 15-30 minutes after study treatment administration.
Time Frame
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Title
Change From Baseline in Post-Bronchodilator FEV1 at Week 6
Description
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-bronchodilator FEV1 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Time Frame
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Title
Change From Baseline in Post-Bronchodilator FEV6 at Week 6
Description
FEV6 is the maximal volume of air exhaled in the first 6 seconds of a forced expiration from a position of full inspiration. Post-bronchodilator FEV6 was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Time Frame
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Title
Change From Baseline in Post-Bronchodilator FVC at Week 6
Description
FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Post-bronchodilator FVC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Time Frame
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Title
Change From Baseline in Post-Bronchodilator IC at Week 6
Description
IC is the maximum volume of air that can be inhaled into the lungs from the normal resting position after breathing out normally. Post-bronchodilator IC was obtained from spirometry, performed 15-30 minutes after bronchodilator (salbutamol) administration.
Time Frame
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Title
Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
Description
BDI: 24-item questionnaire to assess baseline dyspnea in 3 domains, functional impairment; magnitude of task; magnitude of effort. Each item rated on 5-point scale: 0 (very severe), 4 (no impairment). BDI total score range: 0 to 12, lower score=more severe dyspnea. TDI: 24-item questionnaire to measure changes in dyspnea severity from baseline in same 3 domains, as in BDI. Each item rated on 7-point scale: -3 (major deterioration) to 3 (major improvement). TDI total score range: -9 to 9, lower score=more deterioration. BDI/TDI total scores were obtained by adding scores for each of 3 domains.
Time Frame
Baseline, Week 2, 4, 6
Title
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
Description
COPD symptom score: participants rated the severity of their COPD symptoms (cough, breathlessness, and sputum production) in daily symptom dairy according to how they felt during the past 24 hours on a 4-point scale ranging from 0 (none) to 3 (severe). A participant's daily score for each symptom was averaged over each week.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
Description
Participants were issued with rescue medication (Salbutamol MDI [100 mcg/actuation]) and were instructed to use 1-2 puffs as required, as a rescue therapy. All rescue medication use was recorded in daily paper dairy by participant. A participant's daily use (puffs/day) was averaged over each week.
Time Frame
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Title
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
Description
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with a hand-held peak flow device and instructed to perform twice daily (morning and evening) prior to taking any medication. A participant's daily values were averaged over each week.
Time Frame
Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Title
Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
Description
CGI-C: clinician's global impression of a participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time Frame
Week 6
Title
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Description
PGI-C: participant rated instrument to measure participant's clinical condition in terms of change relative to the start of treatment. Rated on a 7-point scale from 1 (very much improved) to 7 (very much worse). Higher score = more affected.
Time Frame
Week 6
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6
Description
Pulse rate: the number of pulsations noted in a peripheral artery per unit of time after participant rested supine for 5 minutes, reported as beats per minute (bpm).
Time Frame
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
Title
Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6
Description
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). BP was measured by sphygmomanometer (manual or semi-automated) using appropriate-sized and calibrated cuff after participant rested in supine position for 5 minutes.
Time Frame
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
Title
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
Description
Standard 12-lead ECG was performed after participant has rested for at least 10 minutes in supine position. ECG intervals (Int) included PR Int (time between onset of atrial depolarization and onset of ventricular depolarization), QRS Int (represented ventricular depolarization), RR Int (time between 2 QRS complex), QT Int (time corresponding to the beginning of depolarization to repolarization of the ventricles), corrected QT (QTc) Int, QT Int corrected by Fridericia's formula (QTcF=QT divided by cube root of RR Int) and Bazett's formula (QTcB=QT divided by square root of RR Int).
Time Frame
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)
Title
Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8
Description
Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.
Time Frame
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)
Title
Change in Post-Study Drug Forced Expiratory Volume in 1 Second (FEV1) Compared to Pre-Study Drug Forced Expiratory Volume in 1 Second (FEV1) at Week 0, 1, 2, 4, and 6
Description
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Post-study drug FEV1 was obtained from spirometry, performed 15-30 minutes after study treatment administration. Pre-study drug FEV1 was obtained from spirometry, performed before study treatment administration.
Time Frame
Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Pfizer Investigational Site
City
Glebe
State/Province
New South Wales
ZIP/Postal Code
2037
Country
Australia
Facility Name
Pfizer Investigational Site
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Zuthpen
ZIP/Postal Code
7207 BA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-326
Country
Poland
Facility Name
Pfizer Investigational Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Pfizer Investigational Site
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
E2 9ZY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
ZIP/Postal Code
M23 QZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3971013&StudyName=Safety%20And%20Efficacy%20Of%20UK-432%2C097%20In%20Chronic%20Obstructive%20Pulmonary%20Disease.
Description
To obtain contact information for a study center near you, click here.

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Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.

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