Pulmonary Disease, Chronic ObstructivePhase 2NCT00430300
Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
A Phase 2 study testing UK-432,097 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 22 sites in 5 countries.
Trial summary
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- UK-432,097
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Jan 2007to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
United Kingdom6 sites
Pfizer Investigational Site
Chertsey, Surrey, KT16 0PZ
Pfizer Investigational Site
Leicester, LE3 9QP
Pfizer Investigational Site
London, E2 9ZY
Pfizer Investigational Site
Manchester, M23 QZ
Pfizer Investigational Site
Newcastle upon Tyne, NE7 7DN
Pfizer Investigational Site
Southampton, SO16 6YD
Canada5 sites
Pfizer Investigational Site
Calgary, Alberta, T1Y 6J4
Pfizer Investigational Site
Hamilton, Ontario, L8N 3Z5
Pfizer Investigational Site
Québec, Quebec, G1V 4G5
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Pfizer Investigational Site
Trois-Rivières, Quebec, G8T 7A1
Australia4 sites
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Daw Park, South Australia, 5041
Pfizer Investigational Site
Glebe, New South Wales, 2037
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Poland4 sites
Pfizer Investigational Site
Bydgoszcz, Poland, 85-326
Pfizer Investigational Site
Gdansk, Poland, 80-952
Pfizer Investigational Site
Lodz, 90-153
Pfizer Investigational Site
Warsaw, Poland, 01-138
Netherlands3 sites
Pfizer Investigational Site
Almelo, 7609 PP
Pfizer Investigational Site
Eindhoven, 5623 EJ
Pfizer Investigational Site
Zuthpen, 7207 BA
About this study
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.
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- UK-432,097, Placebo
- Keywords
- Dry Powder for Inhalation, Chronic Obstructive Pulmonary Disease, Lung Function testing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
Capsules containing 100% lactose administered BID using an atomizer device
| Study group | Role | What they receive |
|---|---|---|
| 150mcg, 450mcg or 1350mcg | Experimental | Active treatment given BID via a double pin monodose capsule inhaler device Receives: Drug: UK-432,097 |
| Placebo | Placebo comparator | Placebo treatment given BID via a single pin monodose inhaler device Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Pre-dose at Baseline, Week 2, 4, 6, 8
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.
Measured: Pre-dose at Baseline, Week 2, 4, 6, 8
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.
Measured: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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.
Measured: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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.
Measured: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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.
Measured: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
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.
Measured: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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.
Measured: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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.
Measured: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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.
Measured: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
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.
Measured: Baseline, Week 2, 4, 6
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.
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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.
Measured: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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.
Measured: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
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.
Measured: Week 6
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.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430300
- Sponsor's protocol ID
- A3971013
- Status last verified
- May 2013
- First submitted
- 30 Jan 2007
- Last updated
- 8 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00430300
- Acronym / sponsor ID
- A3971013
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Dry Powder for Inhalation, Chronic Obstructive Pulmonary Disease, Lung Function testing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 87 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 1 Feb 2007 (estimated)
- Results
- Posted 8 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in patients with chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 150mcg, 450mcg or 1350mcg | Experimental | Drug: UK-432,097Active treatment given BID via a double pin monodose capsule inhaler device |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo treatment given BID via a single pin monodose inhaler device |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UK-432,097Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID. | Drug | 150mcg, 450mcg or 1350mcg |
| PlaceboCapsules containing 100% lactose administered BID using an atomizer device | Drug | Placebo |
Primary outcome
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6
Time frame: Pre-dose at Baseline, 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.
18 secondary outcomes
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2, 4 and 8
Time frame: 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
Time frame: 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
Time frame: Pre-dose at Baseline, Week 2, 4, 6, 8
Change From Baseline in Trough Inspiratory Capacity (IC) at Week 2, 4, 6 and 8
Time frame: Pre-dose at Baseline, Week 2, 4, 6, 8
Change From Baseline in Post-Study Drug FEV1 at Week 2, 4, and 6
Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Change From Baseline in Post-Study Drug FEV6 at Week 2, 4, and 6
Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Change From Baseline in Post-Study Drug FVC at Week 2, 4, and 6
Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Change From Baseline in Post-Study Drug IC at Week 2, 4, and 6
Time frame: 15 to 30 minutes post-dose at Baseline, Week 2, 4, 6
Change From Baseline in Post-Bronchodilator FEV1 at Week 6
Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Change From Baseline in Post-Bronchodilator FEV6 at Week 6
Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Change From Baseline in Post-Bronchodilator FVC at Week 6
Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Change From Baseline in Post-Bronchodilator IC at Week 6
Time frame: 15 to 30 minutes post-bronchodilator administration at Baseline, Week 6
Change From Baseline in Dyspnea (Baseline Dyspnea Index/Transition Dyspnea Index [BDI/TDI]) at Week 2, 4, and 6
Time frame: Baseline, Week 2, 4, 6
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptom Score at Week 1, 2, 3, 4, 5, 6, 7, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Change From Baseline in Rescue Bronchodilator Use at Week 1, 2, 3, 4, 5, 6, 7, and 8
Time frame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEFR) at Week 1, 2, 3, 4, 5, 6, 7, and 8
Time frame: Pre-dose at Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8
Number of Participants With Categorical Scores on Clinical Global Impression of Change (CGI-C)
Time frame: Week 6
Number of Participants With Categorical Scores on Patient Global Impression of Change (PGI-C)
Time frame: Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UK-432,097 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Canada, Australia, Poland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 6 (time frame: Pre-dose at Baseline, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2013.