Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00430300




Registration number
NCT00430300
Ethics application status
Date submitted
30/01/2007
Date registered
1/02/2007
Date last updated
8/07/2013

Titles & IDs
Public title
Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
Scientific 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.
Secondary ID [1] 0 0
A3971013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UK-432,097
Treatment: Drugs - Placebo

Experimental: 150mcg, 450mcg or 1350mcg - Active treatment given BID via a double pin monodose capsule inhaler device

Placebo Comparator: Placebo - Placebo treatment given BID via a single pin monodose inhaler device


Treatment: Drugs: UK-432,097
Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.

Treatment: Drugs: Placebo
Capsules containing 100% lactose administered BID using an atomizer device
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
Timepoint [1] 0 0
Pre-dose at Baseline, Week 6
Secondary outcome [1] 0 0
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
Timepoint [1] 0 0
Pre-dose at Baseline, Week 2, 4, 8
Secondary outcome [2] 0 0
Change From Baseline in Trough Forced Expiratory Volume in 6 Seconds (FEV6) at Week 2, 4, 6 and 8
Timepoint [2] 0 0
Pre-dose at Baseline, Week 2, 4, 6, 8
Secondary outcome [3] 0 0
Change From Baseline in Trough Forced Vital Capacity (FVC) at Week 2, 4, 6 and 8
Timepoint [3] 0 0
Pre-dose at Baseline, Week 2, 4, 6, 8
Secondary outcome [4] 0 0
Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
Timepoint [4] 0 0
Pre-dose at Baseline, Week 2, 4, 6, 8
Secondary outcome [5] 0 0
Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
Timepoint [5] 0 0
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Secondary outcome [6] 0 0
Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
Timepoint [6] 0 0
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Secondary outcome [7] 0 0
Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
Timepoint [7] 0 0
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Secondary outcome [8] 0 0
Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
Timepoint [8] 0 0
15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Secondary outcome [9] 0 0
Change From Baseline in Post-Bronchodilator FEV1 at Week 6
Timepoint [9] 0 0
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Secondary outcome [10] 0 0
Change From Baseline in Post-Bronchodilator FEV6 at Week 6
Timepoint [10] 0 0
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Secondary outcome [11] 0 0
Change From Baseline in Post-Bronchodilator FVC at Week 6
Timepoint [11] 0 0
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Secondary outcome [12] 0 0
Change From Baseline in Post-Bronchodilator IC at Week 6
Timepoint [12] 0 0
15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Secondary outcome [13] 0 0
Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
Timepoint [13] 0 0
Baseline, Week 2, 4, 6
Secondary outcome [14] 0 0
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
Timepoint [14] 0 0
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [15] 0 0
Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
Timepoint [15] 0 0
Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [16] 0 0
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
Timepoint [16] 0 0
Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [17] 0 0
Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
Timepoint [17] 0 0
Week 6
Secondary outcome [18] 0 0
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Timepoint [18] 0 0
Week 6

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Glebe
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Daw Park
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2037 - Glebe
Recruitment postcode(s) [3] 0 0
5041 - Daw Park
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Netherlands
State/province [4] 0 0
Almelo
Country [5] 0 0
Netherlands
State/province [5] 0 0
Eindhoven
Country [6] 0 0
Netherlands
State/province [6] 0 0
Zuthpen
Country [7] 0 0
Poland
State/province [7] 0 0
Bydgoszcz
Country [8] 0 0
Poland
State/province [8] 0 0
Gdansk
Country [9] 0 0
Poland
State/province [9] 0 0
Lodz
Country [10] 0 0
Poland
State/province [10] 0 0
Warszawa
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Surrey
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Leicester
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Manchester
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Newcastle upon Tyne
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in
patients with chronic obstructive pulmonary disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00430300
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00430300