Clinical trial NCT00430300: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Dry Powder for Inhalation
Chronic Obstructive Pulmonary Disease
Lung Function testing
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-01
Enrollment: 87
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
timeFrame: Pre-dose at Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
timeFrame: Pre-dose at Baseline, Week 2, 4, 8
measure: Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
timeFrame: Pre-dose at Baseline, Week 2, 4, 6, 8
measure: Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
timeFrame: Pre-dose at Baseline, Week 2, 4, 6, 8
measure: Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
timeFrame: Pre-dose at Baseline, Week 2, 4, 6, 8
measure: Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
timeFrame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
measure: Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
timeFrame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
measure: Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
timeFrame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
measure: Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
timeFrame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
measure: Change From Baseline in Post-Bronchodilator FEV1 at Week 6
timeFrame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
measure: Change From Baseline in Post-Bronchodilator FEV6 at Week 6
timeFrame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
measure: Change From Baseline in Post-Bronchodilator FVC at Week 6
timeFrame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
measure: Change From Baseline in Post-Bronchodilator IC at Week 6
timeFrame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
measure: Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
timeFrame: Baseline, Week 2, 4, 6
measure: Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
measure: Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
measure: Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
timeFrame: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
measure: Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
timeFrame: Week 6
measure: Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
timeFrame: Week 6
Other outcomes:
measure: Change From Baseline in Pulse Rate at Week 0, 1, 2, 4, and 6
timeFrame: 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
measure: Change From Baseline in Blood Pressure at Week 0, 1, 2, 4, and 6
timeFrame: 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
measure: 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
timeFrame: 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)
measure: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (Heart Rate) at Week 0, 1, 2, 4, 6, and 8
timeFrame: 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)
measure: 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
timeFrame: Pre-dose and 15 to 30 minutes Post-dose at Week 0, 1, 2, 4, 6
Locations:
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Glebe
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Daw Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Québec
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Almelo
country: Netherlands
facility: Pfizer Investigational Site
city: Eindhoven
country: Netherlands
facility: Pfizer Investigational Site
city: Zuthpen
country: Netherlands
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Chertsey
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: