Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT01023516
Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
A Phase 2 study testing AZD9668 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 66 sites in 6 countries.
Trial summary
The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the 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 (COPD)
- 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
- 615 participants
- Where
- 66 sitesin 6 countries
- Study dates
- Nov 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
- FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator
- Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
- At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit
Who cannot join
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Patients who require long term oxygen therapy
- Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Trial locations and contacts
66 sites in 6 countries.
66 sites in 6 countries
Slovakia17 sites
Research Site
Bardejov
Research Site
Bojnice
Research Site
Bratislava
Research Site
Dunajská Streda
Research Site
Humenné
Research Site
Košice
Research Site
Liptovský Hrádok
Research Site
Nové Mesto nad Váhom
Research Site
Nové Zámky
Research Site
Poprad
Research Site
Považská Bystrica
Research Site
Prešov
Research Site
Revúca
Research Site
Spišská Nová Ves
Research Site
Trnava
Research Site
Trstená
Research Site
Žilina
Poland16 sites
Research Site
Bialystok
Research Site
Gdynia
Research Site
Gorzow Wlkp
Research Site
Grodzisk Mazowiecki
Research Site
Jelenia Góra
Research Site
Katowice
Research Site
Kielce
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Piła
Research Site
Skierniewice
Research Site
Szczecin
Research Site
Tarnów
Research Site
Warsaw
Research Site
Wroclaw
Hungary11 sites
Research Site
Balassagyarmat
Research Site
Budapest
Research Site
Debrecen
Research Site
Deszk
Research Site
Győr
Research Site
Nyíregyháza
Research Site
Pécs
Research Site
Százhalombatta
Research Site
Szombathely
Research Site
Törökbálint
Research Site
Vásárosnamény
Czechia9 sites
Research Site
Jihlava
Research Site
Jindřichův Hradec
Research Site
Kladno
Research Site
Krnov
Research Site
Nový Jičín
Research Site
Pardubice
Research Site
Prague
Research Site
Rokycany
Research Site
Třebíč
Bulgaria8 sites
Research Site
Lovech
Research Site
Pleven
Research Site
Plovdiv
Research Site
Rousse
Research Site
Sofia
Research Site
Stara Zagora
Research Site
Troyan Municipality
Research Site
Varna
Romania5 sites
Research Site
Bucharest, Romania
Research Site
Bucharest
Research Site
Constanța, Constanța County
Research Site
Deva, Hunedoara County
Research Site
Iași
About this study
Official title: A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Phase IIb Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol
The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD
- Being tested
- AZD9668, Placebo
- Keywords
- Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD, FEV1, St Georges Respiratory Questionnaire
- 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 bd for 12 weeks
PlaceboDrug
2 x matched placebo to oral tablet bd for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD9668 |
| 2 | Placebo comparator | Not described Receives: Drug: 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 (FEV1) 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: up to week 12
Secondary outcomes (36)
Post-bronchodilator FEV1 (L) - Baseline
Forced expiratory volume in 1 second (FEV1) 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: up to week 12
Pre-bronchodilator FVC (L) - Baseline
Forced vital capacity (FVC) 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: up to week 12
Post-bronchodilator FVC (L) - Baseline
Forced vital capacity (FVC) 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: up to week 12
Baseline Pre-bronchodilator FEV6 (L)
Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Measured: Day 1
End-value Pre-bronchodilator FEV6 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: up to week 12
Baseline Post-bronchodilator FEV6 (L)
Forced expiratory volume in 6 seconds (FEV6) as a measure of lung function, measured post after bronchodilator (salbutamol) use in the clinic.
Measured: Day 1
End-value Post-bronchodilator FEV6 (L)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: up to week 12
Baseline Pre-bronchodilator FEF25-75% (L/Sec)
Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
Measured: Day 1
End-value Pre-bronchodilator FEF25-75% (L/Sec)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: up to week 12
Baseline Post-bronchodilator FEF25-75% (L/Sec)
Forced expiratory flow between 25% to 75% of vital capacity (FEF25-75%) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic.
Measured: Day 1
End-value Post-bronchodilator FEF25-75% (L/Sec)
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
Measured: up to week 12
Pre-bronchodilator IC (L) - Baseline
Inspiratory capacity (IC) 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: up to week 12
Post-bronchodilator IC (L) - Baseline
Inspiratory capacity (IC) 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: up to week 12
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 (PEF)
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).
Measured: Last 6 weeks on treatment
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).
Measured: Last 6 weeks on treatment
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: End of treatment week 12
Use of Reliever Medication
Daily average of number of inhalations of reliever medication
Measured: Last 6 weeks on treatment
Incremental Shuttle Walk Test - Baseline
Endurance time (s)
Measured: Day 1
Incremental Shuttle Walk Test - End Value
Measured: Week 12 - visit 6
Endurance Shuttle Walk Test - Baseline
Endurance time (s)
Measured: Day 1
Endurance Shuttle Walk Test - End Value
Assessed at vist 6 -( last on treatment clinic visit)
Measured: Week 12 - visit 6
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 posted2 Dec 2009 (estimated)
- Study startNov 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 Disease (COPD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Kuna, Professor, Principal investigator, Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023516
- Sponsor's protocol ID
- D0520C00020
- Status last verified
- Jun 2012
- First submitted
- 1 Dec 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 24432712Kuna P, Jenkins M, O'Brien CD, Fahy WA. AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in patients with COPD. Respir Med. 2012 Apr;106(4):531-9. doi: 10.1016/j.rmed.2011.10.020. Epub 2011 Dec 23.
PubMed 22197578
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 Study to Evaluate the Efficacy and Safety of 60mg AZD9668 Administered Orally Twice Daily to Subjects With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Budesonide/Formoterol
- ClinicalTrials.gov ID
- NCT01023516
- Acronym / sponsor ID
- D0520C00020
- Keywords
- Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Dec 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 efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD9668 |
| 2 | Placebo comparator | Drug: Placebo |
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
- FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator
- Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
- At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit
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
- Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids 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 bd for 12 weeks | Drug | 1 |
| Placebo2 x matched placebo to oral tablet bd for 12 weeks | Drug | 2 |
Primary outcome
Baseline Pre-bronchodilator FEV1 (L)
Time frame: Day 1
Forced expiratory volume in 1 second (FEV1) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic.
End-value Pre-bronchodilator FEV1 (L)
Time frame: up to week 12
End of treatment value - week 12 for completers, otherwise Last Observation Carried forward (LOCF)
36 secondary outcomes
Post-bronchodilator FEV1 (L) - Baseline
Time frame: Day 1
Post-bronchodilator FEV1 (L) - End-value
Time frame: up to week 12
Pre-bronchodilator FVC (L) - Baseline
Time frame: Day 1
Pre-bronchodilator FVC (L) - End-value
Time frame: up to week 12
Post-bronchodilator FVC (L) - Baseline
Time frame: Day 1
Post-bronchodilator FVC (L) - End-value
Time frame: up to week 12
Baseline Pre-bronchodilator FEV6 (L)
Time frame: Day 1
End-value Pre-bronchodilator FEV6 (L)
Time frame: up to week 12
Baseline Post-bronchodilator FEV6 (L)
Time frame: Day 1
End-value Post-bronchodilator FEV6 (L)
Time frame: up to week 12
Baseline Pre-bronchodilator FEF25-75% (L/Sec)
Time frame: Day 1
End-value Pre-bronchodilator FEF25-75% (L/Sec)
Time frame: up to week 12
Baseline Post-bronchodilator FEF25-75% (L/Sec)
Time frame: Day 1
End-value Post-bronchodilator FEF25-75% (L/Sec)
Time frame: up to week 12
Pre-bronchodilator IC (L) - Baseline
Time frame: Day 1
Pre-bronchodilator IC (L) - End-value
Time frame: up to week 12
Post-bronchodilator IC (L) - Baseline
Time frame: Day 1
Post-bronchodilator IC (L) - End-value
Time frame: up to week 12
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: Last 6 weeks on treatment
BCSS - Baseline Total Score
Time frame: Baseline
BCSS - End-value Total Score
Time frame: Last 6 weeks on treatment
Sputum Colour - Baseline
Time frame: Baseline
Sputum Colour - End Value
Time frame: End of treatment week 12
Use of Reliever Medication
Time frame: Last 6 weeks on treatment
Incremental Shuttle Walk Test - Baseline
Time frame: Day 1
Incremental Shuttle Walk Test - End Value
Time frame: Week 12 - visit 6
Endurance Shuttle Walk Test - Baseline
Time frame: Day 1
Endurance Shuttle Walk Test - End Value
Time frame: Week 12 - visit 6
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 22197578Kuna P, Jenkins M, O'Brien CD, Fahy WA. AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in patients with COPD. Respir Med. 2012 Apr;106(4):531-9. doi: 10.1016/j.rmed.2011.10.020. Epub 2011 Dec 23.
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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.
Piotr Kuna, Professor principal investigator
Samodzielny Publiczny ZOZ Uniwersytecki Szpital Kliniczny
66 sites in 6 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 (COPD), run by AstraZeneca at 66 sites in 6 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 66 sites in Slovakia, Poland, Hungary, Czechia, Bulgaria and 1 more country. 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 NCT01023516, 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.