COPDPhase 2NCT00242333
A Study to Assess the Safety and Efficacy of Different AD 237 Doses in Adults With COPD
A Phase 2 study testing AD 237 in people with COPD, run by Sosei at 33 sites in 4 countries.
Trial summary
The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- AD 237
- How many people
- 300 participants
- Where
- 33 sitesin 4 countries
- Study dates
- Oct 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea.
- Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value.
- Pre-bronchodilator FEV1/FVC ratio of less than 70%.
- Current or ex-smokers with a smoking history of at least 10 pack years.
Who cannot join
- History of asthma, atopy or allergic rhinitis.
- Other serious respiratory or other medical conditions which may interfere with the outcome of the study.
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
Bulgaria9 sites
Specialized Hospital for Active Treatment Pneumophthysiatric Disease "Kudoglu"
Plovdiv, 4000
Regional Dispensary for Pulmonary Diseases Rousse
Rousse, 7002
5-th Multiprofile Hospital for Active Treatment
Sofia, 1233
MHAT "Alexandrovska"
Sofia, 1431
Specialized Hospital for Active Treatment of Pulmonary Diseases "Sveta Sofia"
Sofia, 1431
Central Clinical Base - Medical Institute - Ministry of the Interior
Sofia, 1606
Military Medical Academy
Sofia, 1606
UMHAT "Stara Zagora" EAD
Stara Zagora, 6003
University Hospital
Varna, 9010
Hungary9 sites
Tudogyintezete Nodradgardony
Balassagyarmat, 2661
III. district Outpatient Clinic
Budapest, 1033
Diagnostic Units Hungary Ltd
Budapest, 1036
Gyogyir XI. Kht.II. Tudogondozo Intezet
Budapest, 1221
Selye Janos Hospital
Komárom, 2900
Karolona Hospital
Mosonmagyaróvár, 9200
Szabolcs Szatmar Bereg Megyei Josa Andras Korhaz
Nyíregyháza, 4400
Fejer County Szent Gyorgy Hospital
Székesfehérvár, 8001
Vas County Markusovszky Hospital
Szombathely, 9700
Poland8 sites
Szpital Wojewodzki
Bielsko-Biala, 43-316
10 Wojskowy Szpital Kliniczny Z Poliklinika
Bydgoszcz, 85-681
Samodzielny Publiczny Centralny Szpital Kliniczny SAM
Katowice, 40-752
Specjalistyczny Osrodek Alergologiczny ALL-MED
Krakow, 31-023
Barlicki University Hospital
Lodz, 90-153
Szpital ZOZ
Oława, 55-200
Specjalistyczna Przychodnia Lekarska "Medikard"
Płock, 09-402
Wielkopolskie Centrum Chorob Pluc I Gruzlicy
Poznan, 60-569
Romania7 sites
Spitalul Clinic de Urgenta Floreasca
Bucharest, 11641
Spitalul de Pneumo Ftiziologie "Sf. Stefan"
Bucharest, 20122
Spitalul Clinic "Colentina"
Bucharest, 20125
Institutul National de Boli Infectioase
Bucharest, 21105
Spitalul Clinic de Boli Infectioase si Tropicale " Dr. Victor Babes "
Bucharest, 30317
Institutul de Pneumologie " Marius Nasta "
Bucharest, 50159
Spitalul Clinic de Urgenta Constanta
Constanța, 900591
About this study
Official title: A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo Controlled Study, Including an Additional Open Label Tiotropium Group, to Assess the Efficacy, Safety and Tolerability of 4 Doses of AD 237 Inhaled Once Daily for 28 Days in Subjects With COPD.
The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).
- Conditions
- COPD
- Being tested
- AD 237
- Keywords
- COPD, COAD, Chronic obstructive pulmonary disease, emphysema, chronic bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD 237Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
Secondary outcomes (1)
Pulmonary function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Sosei
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis
- Investigators
- Robert G Tansley, MD, Study director, Arakis Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242333
- Sponsor's protocol ID
- P-AD237-005
- Status last verified
- May 2006
- First submitted
- 19 Oct 2005
- Last updated
- 16 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized, Double-Blind, Parallel Group, Placebo Controlled Study, Including an Additional Open Label Tiotropium Group, to Assess the Efficacy, Safety and Tolerability of 4 Doses of AD 237 Inhaled Once Daily for 28 Days in Subjects With COPD.
- ClinicalTrials.gov ID
- NCT00242333
- Acronym / sponsor ID
- P-AD237-005
- Conditions
- COPD
- Keywords
- COPD, COAD, Chronic obstructive pulmonary disease, emphysema, chronic bronchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- SoseiIndustry (pharma, biotech, devices)
- Collaborators
- Novartis
- Study start
- Oct 2005
- First posted
- 20 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy, safety and tolerability of AD 237 in patients with chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea.
- Post-bronchodilator FEV1 at no more than 65% and at least 30% of the predicted normal value.
- Pre-bronchodilator FEV1/FVC ratio of less than 70%.
- Current or ex-smokers with a smoking history of at least 10 pack years.
Key exclusion criteria (2 listed)
- History of asthma, atopy or allergic rhinitis.
- Other serious respiratory or other medical conditions which may interfere with the outcome of the study.
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 |
|---|---|---|
| AD 237 | Drug | – |
Primary outcome
Pulmonary function
1 secondary outcome
Pulmonary function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2006.
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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.
Robert G Tansley, MD study director
Arakis Ltd
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AD 237 in people with COPD, run by Sosei at 33 sites in 4 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 2 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 16 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Bulgaria, Hungary, Poland, Romania. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pulmonary function. 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 16 May 2006.