Chronic Obstructive Pulmonary DiseasePhase 3OCEANNCT00628862
Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
A Phase 3 study testing Formoterol Turbuhaler® 4.5mg and Formoterol Turbuhaler® 9 mg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 47 sites in 5 countries.
Trial summary
The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Formoterol Turbuhaler® 4.5mg and Formoterol Turbuhaler® 9 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 613 participants
- Where
- 47 sitesin 5 countries
- Study dates
- Dec 2007to Apr 2009
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
- Current or previous smoker with a smoking history of 10 or more pack years
- Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value
Who cannot join
- History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
- Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
- Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.
Trial locations and contacts
47 sites in 5 countries.
47 sites in 5 countries
Japan28 sites
Research Site
Asahikawa, Hokkaido
Research Site
Chitose, Hokkaido
Research Site
Chiyoda City, Tokyo
Research Site
Hiroshima, Hiroshima
Research Site
Kagoshima, Kagoshima-ken
Research Site
Katano, Osaka
Research Site
Kawasaki, Kangawa
Research Site
Kishiwada, Osaka
Research Site
Kochi, Kochi
Research Site
Kyoto, Kyoto
Research Site
Morioka, Iwate
Research Site
Nagoya, Aichi-ken
Research Site
Naka-gun, Ibaraki
Research Site
Noda, Chiba
Research Site
Obihiro, Hokkaido
Research Site
Osaka, Osaka
Research Site
Ōta, Gunma
Research Site
Ōwa, Gunma
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Seto, Aichi-ken
Research Site
Takatsuiki, Osaka
Research Site
Tomakomai, Hokkaido
Research Site
Touon, Ehime
Research Site
Ube, Yamaguchi
Research Site
Wakayama, Wakayama
Research Site
Yabu, Hyōgo
Research Site
Yanagawa, Fukuoka
Bulgaria8 sites
Research Site
Gabrovo
Research Site
Lovech
Research Site
Pleven
Research Site
Rousse
Research Site
Sofia
Research Site
Stara Zagora
Research Site
Troyan Municipality
Research Site
Varna
Romania4 sites
Research Site
Bucharest
Research Site
Constanța
Research Site
Deva, Hunedoara County
Research Site
Iași
Ukraine4 sites
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv
Research Site
Kyiv
Russia3 sites
Research Site
Kazan'
Research Site
Moscow
Research Site
Saint Petersburg
About this study
Official title: A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-national, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Formoterol Turbuhaler® 4.5mg, Formoterol Turbuhaler® 9 mg, Turbuhaler® placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- 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.
Formoterol Turbuhaler® 4.5mgDrug
Also called Oxis
4.5 mg inhaled twice daily
Formoterol Turbuhaler® 9 mgDrug
Also called Oxis
9 mg inhaled twice daily
Turbuhaler® placeboDrug
placebo inhaled twice daily
| Study group | Role | What they receive |
|---|---|---|
| F 4.5 bid | Experimental | Formoterol 4.5 ug twice daily (bid) Receives: Drug: Formoterol Turbuhaler® 4.5mg |
| F 9.0 bid | Experimental | Formoterol 9.0 ug bid Receives: Drug: Formoterol Turbuhaler® 9 mg |
| PBO | Placebo comparator | Placebo Receives: Drug: Turbuhaler® placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose
FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.
Measured: from baseline up to 12 weeks
Secondary outcomes (12)
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Forced Vital Capacity (FVC) is a spirometric measure of lung function. FVC was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value
Measured: from baseline up to 12 weeks
FEV1 Pre-dose
Lung function (FEV1) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value
Measured: baseline at week 0 and pre-dose at weeks 4, 8 and 12
FVC Pre-dose
Lung function (FVC) was measured before administrations of the study drug (pre-dose). The results are expressed as a percentage of mean FEV1 over visists 4-6 in relation to the baseline (visit 3) value
Measured: baseline at week 0 and pre-dose at weeks 4, 8 and 12
FEV1 5 Minutes Post-dose
Lung function (FEV1) was measured 5 minutes after the first dose of study drug. The results are expressed as a percentage in relation to the baseline value
Measured: baseline and 5 minutes anter first dose
FVC 5 Minutes Post-dose
Lung function (FVC) was measured 5 minutes after the first dose of study drug, The results are expressed as a percentage in relation to the baseline value
Measured: baseline and 5 minutes anter first dose
Change in Peak Expiratory Flow (PEF), Morning
Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the morning). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Measured: run-in period and 12 week
Change in Peak Expiratory Flow (PEF), Evening
Patients were asked to measure and record lung function (peak expiratory flow [PEF] measured in the evening). Average values over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Measured: run-in period and 12 week
Change in Night-time Awakenings Due to Symptoms
Patients were asked to record the night-time awakenings due to symptoms (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Measured: run-in period up to 12 weeks
Breathlessness
Patients were asked to record breathlessness (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Measured: run-in period up to 12 weeks
Cough
Patients were asked to record cough (scored from 0-4 with 4 being the most severe). Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Measured: run-in period up to 12 weeks
Use of Reliever Medication
Patients were asked to record reliever medication use. Period averages over the last 10 days of the run-in period and the whole treatment period were calculated. The results are expressed as the change from the run-in period average value
Measured: 12 weeks (end of run-in to last visit)
St George's Respiratory Questionnaire (SGRQ)
Patients were asked to complete the St George's Respiratory Questionnaire (SGRQ). Subscale symptom score ranges from 0 to 100% and measures the effect of respiratory symptoms, frequency, and severity on quality of life. A score of 0 indicates the best possible status. Results are expressed as the change from baseline score with a decrease in score indicating improvement.
Measured: 12 weeks (end of run-in to last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionApr 2009
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 (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars-Goran Carlsson, MD, Study director, AstraZeneca R&D Lund, SwedenMiron A Bogdan, MD, Principal investigator, Clinica Medic Or, Calea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628862
- Sponsor's protocol ID
- D5122C00001
- Other IDs
- EudraCT no 2007-003999-19
- Acronym
- OCEAN
- Status last verified
- Sep 2012
- First submitted
- 24 Jan 2008
- Last updated
- 25 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 mug twice daily in Japanese and European COPD patients: phase III study results. BMC Pulm Med. 2011 Nov 15;11:51. doi: 10.1186/1471-2466-11-51.
PubMed 22085439
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 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, Multi-national, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00628862
- Acronym / sponsor ID
- OCEAN / D5122C00001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Posted 25 Oct 2012
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 show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| F 4.5 bid | Experimental | Drug: Formoterol Turbuhaler® 4.5mgFormoterol 4.5 ug twice daily (bid) |
| F 9.0 bid | Experimental | Drug: Formoterol Turbuhaler® 9 mgFormoterol 9.0 ug bid |
| PBO | Placebo comparator | Drug: Turbuhaler® placeboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
- Current or previous smoker with a smoking history of 10 or more pack years
- Lung function parameters: FEV1/FVC < 70%, post-bronchodilator and post-bronchodilator FEV1 < 80% of predicted normal value
Key exclusion criteria (3 listed)
- History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
- Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
- Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.
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 |
|---|---|---|
| Formoterol Turbuhaler® 4.5mgAlso: Oxis4.5 mg inhaled twice daily | Drug | F 4.5 bid |
| Formoterol Turbuhaler® 9 mgAlso: Oxis9 mg inhaled twice daily | Drug | F 9.0 bid |
| Turbuhaler® placeboplacebo inhaled twice daily | Drug | PBO |
Primary outcome
Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose
Time frame: from baseline up to 12 weeks
FEV1 (expressed as litres [L]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.
12 secondary outcomes
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Time frame: from baseline up to 12 weeks
FEV1 Pre-dose
Time frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12
FVC Pre-dose
Time frame: baseline at week 0 and pre-dose at weeks 4, 8 and 12
FEV1 5 Minutes Post-dose
Time frame: baseline and 5 minutes anter first dose
FVC 5 Minutes Post-dose
Time frame: baseline and 5 minutes anter first dose
Change in Peak Expiratory Flow (PEF), Morning
Time frame: run-in period and 12 week
Change in Peak Expiratory Flow (PEF), Evening
Time frame: run-in period and 12 week
Change in Night-time Awakenings Due to Symptoms
Time frame: run-in period up to 12 weeks
Breathlessness
Time frame: run-in period up to 12 weeks
Cough
Time frame: run-in period up to 12 weeks
Use of Reliever Medication
Time frame: 12 weeks (end of run-in to last visit)
St George's Respiratory Questionnaire (SGRQ)
Time frame: 12 weeks (end of run-in to last visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22085439Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 mug twice daily in Japanese and European COPD patients: phase III study results. BMC Pulm Med. 2011 Nov 15;11:51. doi: 10.1186/1471-2466-11-51.
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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.
Lars-Goran Carlsson, MD study director
AstraZeneca R&D Lund, Sweden
Miron A Bogdan, MD principal investigator
Clinica Medic Or, Calea
47 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Formoterol Turbuhaler® 4.5mg and Formoterol Turbuhaler® 9 mg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 47 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: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Japan, Bulgaria, Romania, Ukraine, Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Oct 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?
Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose (time frame: from baseline up to 12 weeks). 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 NCT00628862, which also lists 1 linked publication.
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 25 Oct 2012.