Please note that the ANZCTR website will be unavailable from 9am until 9.30am (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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) - 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.
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) - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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/show/NCT00430300