Chronic Obstructive Pulmonary DiseasePhase 2NCT00949975
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
A Phase 2 study testing AZD9668 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 105 sites in 12 countries.
Trial summary
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- AZD9668
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 838 participants
- Where
- 105 sitesin 12 countries
- Study dates
- Jul 2009to Aug 2010
- 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
- Diagnosis of COPD with symptoms over 1 year
- Smokers or ex-smokers
- Males or post-menopausal females between 40 and 80 years old
- Able to use electronic devices
Who cannot join
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Patients who require long term oxygen therapy
- Treatment with antibiotics within 4 weeks of study visit 1b
Trial locations and contacts
105 sites in 12 countries.
105 sites in 12 countries
Japan24 sites
Research Site
Asahikawa, Hokkaido
Research Site
Bunkyō City
Research Site
Chūō, Tokyo
Research Site
Fukuoka, Fukuoka
Research Site
Himeji, Hyōgo
Research Site
Hiroshima, Hiroshima
Research Site
Kagoshima, Kagoshima-ken
Research Site
Kawasaki, Kanagawa
Research Site
Kishiwada, Osaka
Research Site
Kita-ku, Sakai, Osaka
Research Site
Kochi, Kochi
Research Site
Matsue, Shimane
Research Site
Matsumoto, Nagano
Research Site
Nakano-ku, Tokyo
Research Site
Nihommatsu, Fukushima
Research Site
Noda, Chiba
Research Site
Saiki, Oita Prefecture
Research Site
Sapporo, Hokkaido
Research Site
Seto, Aichi-ken
Research Site
Tanabe, Wakayama
Research Site
Touon, Ehime
Research Site
Ukyo-ku, Kyoto, Kyoto
Research Site
Yokohama, Kanagawa
Research Site
Yukuhashi, Fukuoka
Canada14 sites
Research Site
Antigonish Nova Scotia, Nova Scotia
Research Site
Edmonton, Alberta
Research Site
Grimsby, Ontario
Research Site
Hamilton, Ontario
Research Site
Kingston, Ontario
Research Site
La Malbaie, Quebec
Research Site
Mirabel, Quebec
Research Site
Mississauga, Ontario
Research Site
Mount Pearl, Newfoundland and Labrador
Research Site
Québec, Quebec
Research Site
Saint-Léonard, Quebec
Research Site
Saskatoon, Saskatchewan
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Slovakia11 sites
Research Site
Bardejov
Research Site
Bojnice
Research Site
Bratislava
Research Site
Košice
Research Site
Nové Mesto nad Váhom
Research Site
Nové Zámky
Research Site
Poprad
Research Site
Prešov
Research Site
Trnava
Research Site
Žilina
Research Site
Zvolen
United States9 sites
Research Site
Boerne, Texas
Research Site
Council Bluffs, Iowa
Research Site
Fullerton, California
Research Site
Gaffney, South Carolina
Research Site
Greenville, South Carolina
Research Site
Hickory, North Carolina
Research Site
Jefferson Hills, Pennsylvania
Research Site
Spartanburg, South Carolina
Research Site
Valparaiso, Indiana
Poland9 sites
Research Site
Bydgoszcz
Research Site
Chęciny
Research Site
Krakow
Research Site
Ostrów Wielkopolski
Research Site
Poznan
Research Site
Proszowice
Research Site
Tczew
Research Site
Wroclaw
Research Site
Zawadzkie
Australia8 sites
Research Site
Adelaide, South Australia
Research Site
Carina Heights, Queensland
Research Site
Concord, New South Wales
Research Site
Daw Park, South Australia
Research Site
Glebe, New South Wales
Research Site
Kogarah, New South Wales
Research Site
Nedlands, Western Australia
Research Site
Parkville, Victoria
Russia6 sites
Research Site
Barnaul, Russia
Research Site
Kazan', Russia
Research Site
Moscow, Russia
Research Site
Novosibirsk, Russia
Research Site
Saint Petersburg, Russia
Research Site
Yekaterinburg, Russia
South Korea6 sites
Research Site
Anyang
Research Site
Bucheon-si
Research Site
Daegu
Research Site
Seoul
Research Site
Uijeongbu-si, Gyeonggi-do
Research Site
Wŏnju, Gangwon-do
Germany5 sites
Research Site
Berlin
Research Site
Fulda
Research Site
Hanover
Research Site
Leipzig
Research Site
Marburg
Taiwan5 sites
Research Site
Kaohsiung City
Research Site
Keelung
Research Site
Taichung
Research Site
Taipei
Research Site
Taoyuan
Ukraine5 sites
Research Site
Dnipropetrovsk
Research Site
Ivano-Frankivsk, Ivano-Frankivsk Oblast
Research Site
Kharkiv
Research Site
Kyiv
Research Site
Luhansk, Ukraine
Philippines3 sites
Research Site
Iloilo City
Research Site
Lipa City, Batangas
Research Site
Quezon City
About this study
Official title: A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multinational, Phase IIb Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- AZD9668, AZD9668 Placebo
- Keywords
- Chronic, Obstructive, Pulmonary, Lung, Respiratory disease, Efficacy, Safety and tolerability, Placebo-controlled, Pharmacokinetics, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiolitis Obliterans Syndrome, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9668Drug
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
AZD9668Drug
2 x 10 mg oral tablets twice daily (bid) for 12 weeks
AZD9668Drug
2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks
AZD9668 PlaceboDrug
2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AZD9668 active treatment Receives: Drug: AZD9668 |
| 2 | Active comparator | AZD9668 active treatment Receives: Drug: AZD9668 |
| 3 | Active comparator | AZD9668 active treatment Receives: Drug: AZD9668 |
| 4 | Placebo comparator | AZD9668 placebo treatment Receives: Drug: AZD9668 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Pre-bronchodilator FEV1 (L)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Measured: Day 1
End-value Pre-bronchodilator FEV1 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: Measured at clinic visits: 1, 4, 8 and 12 weeks
Secondary outcomes (26)
Post-bronchodilator FEV1 (L) - Baseline
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Measured: Day 1
Post-bronchodilator FEV1 (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: Measured at clinic visits: 1, 4, 8 and 12 weeks
Pre-bronchodilator FVC (L) - Baseline
Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Measured: Day 1
Pre-bronchodilator FVC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: Measured at clinic visits: 1, 4, 8 and 12 weeks
Post-bronchodilator FVC (L) - Baseline
Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Measured: Day 1
Post-bronchodilator FVC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: Measured at clinic visits: 1, 4, 8 and 12 weeks
Pre-bronchodilator IC (L) - Baseline
Inspiratory Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
Measured: Day 1
Pre-bronchodilator IC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: Measured at clinic visits: 1, 4, 8 and 12 weeks
Post-bronchodilator IC (L) - Baseline
Inspiratory Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic
Measured: Day 1
Post-bronchodilator IC (L) - End-value
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: Measured at clinic visits: 1, 4, 8 and 12 weeks
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment
Measured: Baseline
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Peak Expiratory Flow (L/min)
Measured: Last 6 weeks on treatment
FEV1 - Baseline Measured by Patient at Home (L) in the Morning
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.Baseline is the mean of last 10 days of data before start of treatment
Measured: Baseline
FEV1 - End-value Measured by Patient at Home (L) in the Morning
Forced Expiratory Volume in 1 second (L)
Measured: Last 6 weeks on treatment
EXACT - Baseline Total Score
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Baseline is the mean of last 10 days of data before start of treatment.
Measured: Baseline
EXACT - End-value Total Score
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status)scale). Last 6 weeks on treatment.
Measured: Measured daily in the evening for 12 weeks
BCSS - Baseline Total Score
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status)scale).Baseline is the mean of last 10 days of data before start of treatment
Measured: Baseline
BCSS - End-value Total Score
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0(best health status) to 12(worst possible status)scale). Last 6 weeks on treatment
Measured: Measured daily in the evening for 12 weeks
Sputum Colour - Baseline
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).
Measured: Baseline
Sputum Colour - End Value
Sputum Colour as assessed by the Bronkotest scale, reported on a scale from 1 - clear (best health status) to 5 - dark green (worst possible health status).End of treatment week 12
Measured: Measured at clinic visits:1, 4, 8 and 12 weeks
Use of Reliever Medication
Daily average of number of inhalations of reliever medication
Measured: Last 6 weeks on treatment
Six-minute Walk Test - Distance Walked at Baseline (m)
Measured: Day 1
Six-minute Walk Test - End-value Distance Walked (m)
distance walked on vist 6 - last on treatment clinic visit
Measured: Measured Day 1 and 12 weeks
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).
Measured: Day 1
St George's Respiratory Questionnaire (COPD) - End-value Overall Score
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).questionaire assessed on vist 6 -( last on treatment clinic visit)
Measured: Measured Day 1 and 12 weeks
Exacerbations - Clinic Defined
Number of patients having a clinic defined disease exacerbation
Measured: Duration of the the treatment period - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2010
- Study completionAug 2010
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 838 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Volgemeier, Dr., Principal investigator, Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949975
- Sponsor's protocol ID
- D0520C00012
- Status last verified
- Jun 2012
- First submitted
- 21 Jul 2009
- Last updated
- 3 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
PubMed 25287629Leidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
PubMed 24432712Vogelmeier C, Aquino TO, O'Brien CD, Perrett J, Gunawardena KA. A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium. COPD. 2012 Apr;9(2):111-20. doi: 10.3109/15412555.2011.641803.
PubMed 22458939
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multinational, Phase IIb Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at 3 Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
- ClinicalTrials.gov ID
- NCT00949975
- Acronym / sponsor ID
- D0520C00012
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic, Obstructive, Pulmonary, Lung, Respiratory disease, Efficacy, Safety and tolerability, Placebo-controlled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 838 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Posted 3 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AZD9668AZD9668 active treatment |
| 2 | Active comparator | Drug: AZD9668AZD9668 active treatment |
| 3 | Active comparator | Drug: AZD9668AZD9668 active treatment |
| 4 | Placebo comparator | Drug: AZD9668 PlaceboAZD9668 placebo treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COPD with symptoms over 1 year
- Smokers or ex-smokers
- Males or post-menopausal females between 40 and 80 years old
- Able to use electronic devices
Key exclusion criteria (4 listed)
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Patients who require long term oxygen therapy
- Treatment with antibiotics within 4 weeks of study visit 1b
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 |
|---|---|---|
| AZD96682 x 30 mg oral tablets twice daily (bid) for 12 weeks | Drug | 1 |
| AZD96682 x 10 mg oral tablets twice daily (bid) for 12 weeks | Drug | 2 |
| AZD96682 x 2.5 mg oral tablets twice daily (bid) for 12 weeks | Drug | 3 |
| AZD9668 Placebo2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks | Drug | 4 |
Primary outcome
Baseline Pre-bronchodilator FEV1 (L)
Time frame: Day 1
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic
End-value Pre-bronchodilator FEV1 (L)
Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
26 secondary outcomes
Post-bronchodilator FEV1 (L) - Baseline
Time frame: Day 1
Post-bronchodilator FEV1 (L) - End-value
Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks
Pre-bronchodilator FVC (L) - Baseline
Time frame: Day 1
Pre-bronchodilator FVC (L) - End-value
Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks
Post-bronchodilator FVC (L) - Baseline
Time frame: Day 1
Post-bronchodilator FVC (L) - End-value
Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks
Pre-bronchodilator IC (L) - Baseline
Time frame: Day 1
Pre-bronchodilator IC (L) - End-value
Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks
Post-bronchodilator IC (L) - Baseline
Time frame: Day 1
Post-bronchodilator IC (L) - End-value
Time frame: Measured at clinic visits: 1, 4, 8 and 12 weeks
PEF - Baseline Measured by Patient at Home (L/Min) in the Morning
Time frame: Baseline
PEF - End-value Measured by Patient at Home (L/Min) in the Morning
Time frame: Last 6 weeks on treatment
FEV1 - Baseline Measured by Patient at Home (L) in the Morning
Time frame: Baseline
FEV1 - End-value Measured by Patient at Home (L) in the Morning
Time frame: Last 6 weeks on treatment
EXACT - Baseline Total Score
Time frame: Baseline
EXACT - End-value Total Score
Time frame: Measured daily in the evening for 12 weeks
BCSS - Baseline Total Score
Time frame: Baseline
BCSS - End-value Total Score
Time frame: Measured daily in the evening for 12 weeks
Sputum Colour - Baseline
Time frame: Baseline
Sputum Colour - End Value
Time frame: Measured at clinic visits:1, 4, 8 and 12 weeks
Use of Reliever Medication
Time frame: Last 6 weeks on treatment
Six-minute Walk Test - Distance Walked at Baseline (m)
Time frame: Day 1
Six-minute Walk Test - End-value Distance Walked (m)
Time frame: Measured Day 1 and 12 weeks
St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline
Time frame: Day 1
St George's Respiratory Questionnaire (COPD) - End-value Overall Score
Time frame: Measured Day 1 and 12 weeks
Exacerbations - Clinic Defined
Time frame: Duration of the the treatment period - 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25287629Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
- Derived from this study: PubMed 24432712Leidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
- Derived from this study: PubMed 22458939Vogelmeier C, Aquino TO, O'Brien CD, Perrett J, Gunawardena KA. A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium. COPD. 2012 Apr;9(2):111-20. doi: 10.3109/15412555.2011.641803.
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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.
Claus Volgemeier, Dr. principal investigator
Director der Klinik fur Innere Medizin mit Schwerpunkt Pneumologie-Universitatsklinikum GieBen und Marburg, D-35043 Marburg, Germany
105 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD9668 in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 105 sites in 12 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in Japan, Canada, Slovakia, United States, Poland and 7 more countries. 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 3 Aug 2012). 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?
Baseline Pre-bronchodilator FEV1 (L) (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00949975, which also lists 3 linked publications.
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 3 Aug 2012.