Chronic Obstructive Pulmonary DiseasePhase 4CODEXNCT00489853
Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD
A Phase 4 study testing budesonide/formoterol Turbuhaler 320/9µg and formoterol Turbuhaler 9µg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 9 sites in 2 countries.
Trial summary
The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease. 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?
- budesonide/formoterol Turbuhaler 320/9µg and formoterol Turbuhaler 9µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jul 2007to Aug 2008
- Phase
- Phase 4
- 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
- >=40 years of age
- diagnosed COPD with symptoms >= 2 years
- pre-bronchodilatory FEV1 <=50% of PN
Who cannot join
- Current respiratory tract disorder other than COPD
- history of asthma or rhinitis
- significant or unstable cardiovascular disorder
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Germany8 sites
Research Site
Berlin
Research Site
Erfurt
Research Site
Fulda
Research Site
Fürth
Research Site
Geesthacht
Research Site
Grobhansdorf
Research Site
Leipzig
Research Site
Neuruppin
About this study
Official title: A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).
The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- budesonide/formoterol Turbuhaler 320/9µg, formoterol Turbuhaler 9µg, Placebo
- Keywords
- 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.
budesonide/formoterol Turbuhaler 320/9µgDrug
Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms
formoterol Turbuhaler 9µgDrug
Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
PlaceboOther
Placebo, 1 inhalation twice daily
| Study group | Role | What they receive |
|---|---|---|
| Symbicort then Formoterol then Placebo | Experimental | Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily Receives: Drug: budesonide/formoterol Turbuhaler 320/9µg; Drug: formoterol Turbuhaler 9µg; Other: Placebo |
| Formoterol then Symbicort then Placebo | Experimental | Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily Receives: Drug: budesonide/formoterol Turbuhaler 320/9µg; Drug: formoterol Turbuhaler 9µg; Other: Placebo |
| Placebo then Formoterol then Symbicort | Placebo comparator | Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily Receives: Drug: budesonide/formoterol Turbuhaler 320/9µg; Drug: formoterol Turbuhaler 9µg; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.
Measured: Single measurement taken1 hour post-dose at the end of each 1-week treatment period
Secondary outcomes (29)
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose
Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.
Measured: Single measurement taken 6 hours post-dose at the end of each 1-week treatment period
Forced Expiratory Flow (FEV1) Pre-dose
The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
Measured: Pre-dose at the start of treatment and pre-dose after one week of treatment
Forced Vital Capacity (FVC) Pre-dose
The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
Measured: Pre-dose at the start of treatment and pre-dose after one week of treatment
Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)
The mean of the changes for each patient between the pre-dose value at the start of treatment and the pre-dose value after one week of treatment.
Measured: Pre-dose at the start of treatment and pre-dose after one week of treatment
Peak Expiratory Flow (PEF) Before Morning Dose
The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period.
Measured: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Sleep Score
The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (symptoms did not cause a sleep problem) to 4 (did not sleep at all due to symptoms).
Measured: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Breathlessness Score
The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any difficulty in breathing) to 4 (almost constant difficulties in breathing). All patients with data from both periods are included.
Measured: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Chest Tightness Score
The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of any discomfort) to 4 (almost constant discomfort).
Measured: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Cough Score
The change in average value for the run-in or wash-out period to the average value of the subsequent treatment period, with an ordinal scale of 0 (unaware of coughing) to 4 (never free of need to cough).
Measured: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Number of Inhalations of Reliever Medication
The change in average daily use for the run-in or wash-out period to the average daily use of the subsequent treatment period.
Measured: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose
The Borg CR10 Scale consists of 10-point score that the patients pointed to so as to indicate their level of dyspnea before and during exercise testing (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness. Patients are allowed to assign an even higher number depending on their perceived level of breathlessness).
Measured: Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose
The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
Measured: Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose
The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort).
Measured: Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose
The level of breathing discomfort experienced by patients, on a scale of 0 (no breathing discomfort at all) to >10 (absolute maximum breathing discomfort). All patients with data are included.
Measured: Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period
Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period
Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET
Treatment means from individual participant data.
Measured: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score
Score from a questionnaire, with scores ranging form 0 (perfect health) to 100 (worst possible state). Includes all patients with data.
Measured: Single measurement taken at the end of each 1-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionAug 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomas Andersson, MD, Study director, AstraZenecaHeinrich Worth, MD, Principal investigator, Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489853
- Sponsor's protocol ID
- D5892C00014
- Other IDs
- Eudract No: 2006-006519-60
- Acronym
- CODEX
- Status last verified
- Jul 2012
- First submitted
- 19 Jun 2007
- Last updated
- 30 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Worth H, Forster K, Eriksson G, Nihlen U, Peterson S, Magnussen H. Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD. Respir Med. 2010 Oct;104(10):1450-9. doi: 10.1016/j.rmed.2010.07.006. Epub 2010 Aug 7.
PubMed 20692140
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00489853
- Acronym / sponsor ID
- CODEX / D5892C00014
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Posted 30 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 purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symbicort then Formoterol then Placebo | Experimental | Drug: budesonide/formoterol Turbuhaler 320/9µg, Drug: formoterol Turbuhaler 9µg, Other: PlaceboSymbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily |
| Formoterol then Symbicort then Placebo | Experimental | Drug: budesonide/formoterol Turbuhaler 320/9µg, Drug: formoterol Turbuhaler 9µg, Other: PlaceboFormoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily |
| Placebo then Formoterol then Symbicort | Placebo comparator | Drug: budesonide/formoterol Turbuhaler 320/9µg, Drug: formoterol Turbuhaler 9µg, Other: PlaceboPlacebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >=40 years of age
- diagnosed COPD with symptoms >= 2 years
- pre-bronchodilatory FEV1 <=50% of PN
Key exclusion criteria (3 listed)
- Current respiratory tract disorder other than COPD
- history of asthma or rhinitis
- significant or unstable cardiovascular disorder
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 |
|---|---|---|
| budesonide/formoterol Turbuhaler 320/9µgSymbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms | Drug | Formoterol then Symbicort then Placebo, Placebo then Formoterol then Symbicort, Symbicort then Formoterol then Placebo |
| formoterol Turbuhaler 9µgFormoterol Turbuhaler 9 micrograms, 1 inhalation twice daily | Drug | Formoterol then Symbicort then Placebo, Placebo then Formoterol then Symbicort, Symbicort then Formoterol then Placebo |
| PlaceboPlacebo, 1 inhalation twice daily | Other | Formoterol then Symbicort then Placebo, Placebo then Formoterol then Symbicort, Symbicort then Formoterol then Placebo |
Primary outcome
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose
Time frame: Single measurement taken1 hour post-dose at the end of each 1-week treatment period
Treatment means from individual patient data. Patients with only one EET value where excluded since this model, with patient and period as fixed factors, required data from at least two periods.
29 secondary outcomes
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 6 Hour Post-dose
Time frame: Single measurement taken 6 hours post-dose at the end of each 1-week treatment period
Forced Expiratory Flow (FEV1) Pre-dose
Time frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
Forced Vital Capacity (FVC) Pre-dose
Time frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
Vital Capacity (VC) Pre-dose (Change From Pre-treatment to Treatment)
Time frame: Pre-dose at the start of treatment and pre-dose after one week of treatment
Peak Expiratory Flow (PEF) Before Morning Dose
Time frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Sleep Score
Time frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Breathlessness Score
Time frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Chest Tightness Score
Time frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Cough Score
Time frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Number of Inhalations of Reliever Medication
Time frame: Daily diary data entered during the 1-week run-in or wash-out period and the subsequent 1-week treatment period
Borg CR10 Score Before Exercise Endurance Time (EET) Performed 1 Hour Post-dose
Time frame: Single measurement performed at rest prior to exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Borg CR10 Score After Exercise Endurance Time (EET) Performed 1 Hour Post-dose
Time frame: Single measurement performed after exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Borg CR10 Score Before Exercise Endurance Time (EET) Performed 6 Hour Post-dose
Time frame: Single measurement performed at rest prior to exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Borg CR10 Score After Exercise Endurance Time (EET) Performed 6 Hours Post-dose
Time frame: Single measurement performed after exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 1 Hour Postdose
Time frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Inspiratory Capacity (IC) Before Exercise Endurance Time (EET) Performed 6 Hours Post-dose
Time frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Vital Capacity (VC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 1hour post-dose at the end of each 1-week treatment period
Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Residual Volume (RV) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 1 Hour Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 1 Hour Post-dose Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 1 hour post-dose at the end of each 1-week treatment period
Vital Capacity (VC) (Body Plethysmography) Performed Before 6 Hour Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Inspiratory Capacity (IC) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Forced Respiratory Capacity (FRC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Residual Volume (RV) (Body Plethysmography) Performed Before 6 Hour Post-dose Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 6 hous post-dose at the end of each 1-week treatment period
Total Lung Capacity (TLC) (Body Plethysmography) Performed Before 6 Hours Post-dose Exercise Endurance Time (EET)
Time frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
Specific Airway Resistance (sRaw) (Body Plethysmography) Performed Before 6 Hours Post-dose EET
Time frame: Single measurement obtained before exercise endurance test performed 6 hours post-dose at the end of each 1-week treatment period
SGRQ-C (St. George's Respiratory Questionnaire for COPD Patients) Total Score
Time frame: Single measurement taken at the end of each 1-week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20692140Worth H, Forster K, Eriksson G, Nihlen U, Peterson S, Magnussen H. Budesonide added to formoterol contributes to improved exercise tolerance in patients with COPD. Respir Med. 2010 Oct;104(10):1450-9. doi: 10.1016/j.rmed.2010.07.006. Epub 2010 Aug 7.
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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.
Tomas Andersson, MD study director
AstraZeneca
Heinrich Worth, MD principal investigator
Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing budesonide/formoterol Turbuhaler 320/9µg and formoterol Turbuhaler 9µg in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 9 sites in 2 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 30 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 9 sites in Germany, Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 30 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?
Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose (time frame: Single measurement taken1 hour post-dose at the end of each 1-week treatment period). 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 NCT00489853, 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 30 Aug 2012.