Chronic Obstructive Pulmonary Disease, COPDPhase 4NCT00496470

Evaluation of Efficacy and Safety of Symbicort® as an add-on Treatment to Spiriva® in Patients With Severe COPD.

A Phase 4 study testing Symbicort (budesonide/formoterol turbuhaler 320/9ug) and Spiriva (tiotropium bromide 18ug) in people with Chronic Obstructive Pulmonary Disease, COPD, run by AstraZeneca at 93 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease, COPD
What is being tested?: Symbicort (budesonide/formoterol turbuhaler 320/9ug) and Spiriva (tiotropium bromide 18ug)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 660 participants
Where: 93 sitesin 9 countries
Study dates: May 2007to Jun 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

93 sites in 9 countries.

Country

City, postcode or hospital

93 sites in 9 countries

France14 sites

Research Site
Chamalières
Research Site
Creil
Research Site
Férolles-Attilly
Research Site
Grasse
Research Site
Lille
Research Site
Marseille
Research Site
Metz
Research Site
Montpellier
Research Site
Perpignan
Research Site
Poitiers
Research Site
Saint-Laurent-du-Var
Research Site
Sélestat
Research Site
Strasbourg
Research Site
Toulouse

Other trials in France

Slovakia13 sites

Research Site
Košice
Research Site
Liptovský Hrádok
Research Site
Lučenec
Research Site
Nové Mesto nad Váhom
Research Site
Nové Zámky
Research Site
Piešťany
Research Site
Poprad
Research Site
Považská Bystrica
Research Site
Prešov
Research Site
Prievidza
Research Site
Revúca
Research Site
Trnava
Research Site
Žilina

Other trials in Slovakia

Hungary12 sites

Research Site
Aszód
Research Site
Baja
Research Site
Balassagyarmat
Research Site
Budapest
Research Site
Cegléd
Research Site
Debrecen
Research Site
Füzesabony
Research Site
Jászberény
Research Site
Komló
Research Site
Nyíregyháza
Research Site
Törökbálint
Research Site
Vásárosnamény

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Canada11 sites

Research Site
Calgary, Alberta
Research Site
Halifax, Nova Scotia
Research Site
La Malbaie, Quebec
Research Site
Mississauga, Ontario
Research Site
Québec
Research Site
Saskatoon, Saskatchewan
Research Site
St. John's, Newfoundland and Labrador
Research Site
Toronto, Ontario
Research Site
Trois-rivires, Quebec
Research Site
Vancouver, British Columbia
Research Site
Winnipeg, Manitoba

Other trials in Canada

Australia10 sites

Research Site
Adelaide, South Australia
Research Site
Auchenflower, Queensland
Research Site
Carina Heights, Queensland
Research Site
Clayton, Victoria
Research Site
Concord, New South Wales
Research Site
Daw Park, South Australia
Research Site
Malvern, Victoria
Research Site
Nedlands, Western Australia
Research Site
North Mackay, Queensland
Research Site
Sydney, New South Wales

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Germany9 sites

Research Site
Berlin
Research Site
Gelsenkirchen
Research Site
Hagen
Research Site
Hanover
Research Site
Kassel
Research Site
Koblenz
Research Site
Leipzig
Research Site
Marburg
Research Site
Potsdam

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Poland9 sites

Research Site
Bydgoszcz
Research Site
Chrzanów
Research Site
Iława
Research Site
Krakow
Research Site
Łomża
Research Site
Piekary Śląskie
Research Site
Tarnów
Research Site
Turek
Research Site
Zawadzkie

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Sweden9 sites

Research Site
Åtvidaberg
Research Site
Höllviken
Research Site
Limhamn
Research Site
Lindesberg, Örebro County
Research Site
Lund
Research Site
Malmö
Research Site
Motala
Research Site
Stockholm
Research Site
Uppsala

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Spain6 sites

Research Site
Barcelona, Catalonia
Research Site
Madrid, Madrid
Research Site
Pontevedra, Galicia
Research Site
Requena (valencia), Valencia
Research Site
Reus (tarragona), Catalonia
Research Site
Valencia, Valencia

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About this study

Official title: A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily

Conditions: Chronic Obstructive Pulmonary Disease, COPD
Being tested: Symbicort (budesonide/formoterol turbuhaler 320/9ug), Spiriva (tiotropium bromide 18ug)
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.

Symbicort (budesonide/formoterol turbuhaler 320/9ug)Drug
Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Spiriva (tiotropium bromide 18ug)Drug
Spiriva (tiotropium bromide 18ug)

Study groups in NCT00496470
Study group	Role	What they receive
Symbicort+TIO	Active comparator	Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily Receives: Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug)
Spiriva® + Placebo Turbuhaler	Active comparator	Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily Receives: Drug: Spiriva (tiotropium bromide 18ug)

What is being measured

The primary outcome is the main question the study is designed to answer.

Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Measured: Baseline to 12 weeks

Secondary outcomes (36)

Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose
Change in the 5 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Measured: Baseline to 12 weeks
Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose
Change in the 60 min post-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Measured: Baseline to 12 weeks
Forced Vital Capacity (FVC) Pre-dose
Change in the pre-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Measured: Baseline to 12 weeks
Forced Vital Capacity (FVC) 5 Minutes Post-dose
Change in the 5 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Measured: Baseline to 12 weeks
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Change in the 60 min post-dose FVC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12
Measured: Baseline to 12 weeks
Inspiratory Capacity (IC) Pre-dose
Change in the pre-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Measured: Baseline to 12 weeks
Inspiratory Capacity (IC) 60 Minutes Post-dose
Change in the 60 min post-dose IC from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)
Measured: Baseline to 12 weeks
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score
Change in total score from baseline (Visit 3) to end of treatment (Visit 6, or last available visit).
SGRQ-C is a health related quality of life questionnaire consisting of 40 items divided into two components: 1) symptoms, 2) activity\& impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.
Measured: Baseline and 12 weeks
Morning Peak Expiratory Flow (PEF) Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Evening Peak Expiratory Flow (PEF) Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Morning Diary FEV1 Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Evening Diary FEV1, Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Morning Diary FEV1, 5 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Morning Diary FEV1, 15 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
Measured: Baseline to 12 weeks
GCSQ Score, 5 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
Measured: Baseline to 12 weeks
GCSQ Score, 15 Minutes Post-dose
Daily diary record. Change in average values from run-in to the full treatment period.
The GCSQ consisted of two questions that required the patient to rate shortness of breath and feelings of chest tightness. The patients recorded their response on a five-point Likert-type scale ranging from 0 (not at all) to 4 (extremely), the total score being calculated as the average score of the two questions.
Measured: Baseline to 12 weeks
Capacity of Day Living in the Morning (CDLM) Score
Daily diary record. Change in average values from run-in to the full treatment period.
The CDLM questionnaire is as a questionnaire to report on patient's ability to carry out each of six different morning activities (score ranging from 0 "not performed" to 1"performed") and rank the difficulty of performing each of those activities (score ranging from 0 "so difficult that the activity could not be carried out by the patient on their own" to 5 "activity was not at all difficult to carry out". Total score for each morning activity range from 0-6. Total score for whole CDLM questionnaire range from 0-36.
Measured: Baseline to 12 weeks
Use of Rescue Medication, Night
Daily diary record - Night, after evening measurement till morning. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Use of Rescue Medication, Morning
Daily diary record - Morning, after morning measurement till midday. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Use of Rescue Medication, Day
Daily diary record - Day, after morning measurement till evening. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
Use of Rescue Medication, Total
Daily diary record - Total, 24 hours, during the night, and during the day. Change in average values from run-in to the full treatment period
Measured: Baseline to 12 weeks
COPD Symptoms, Breathing Score
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Measured: Baseline to 12 weeks
COPD Symptoms, Sleeping Score
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Measured: Baseline to 12 weeks
COPD Symptoms, Chest Score
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Measured: Baseline to 12 weeks
COPD Symptoms, Cough Score
Daily diary record. Change in average values from run-in to the full treatment period. Symptom scale 0 - 4 (0) None (1) Mild (2) Moderate (3) Marked (4) Severe
Measured: Baseline to 12 weeks
Severe COPD Exacerbations
Patients with worsening of COPD leading to treatment with systemic steroids (oral or parenteral), emergency room treatment or hospitalisation
Measured: 12 weeks
Serum High-sensitivity C-reactive Protein (hsCRP)
Ratio of treatment period mean to run-in value
Measured: Baseline to 12 weeks
Serum Interleukin 6 (IL-6)
Ratio of treatment period mean to run-in value
Measured: Baseline to 12 weeks
Serum Interleukin 8 (IL-8)
Ratio of treatment period mean to run-in value
Measured: Baseline to 12 weeks
Serum Monocyte Chemoattractant Protein-1 (MCP-1)
Ratio of treatment period mean to run-in value
Measured: Baseline to 12 weeks
Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)
Ratio of treatment period mean to run-in value
Measured: Baseline to 12 weeks
Serum Tumor Necrosis Factor-alpha (TNF-alpha)
Ratio of treatment period mean to run-in value
Measured: Baseline to 12 weeks
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Ratio of treatment period mean to run-in value
Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2007Jun 2008

First posted4 Jul 2007 (estimated)
Study startMay 2007
Primary completionJun 2008
Study completionJun 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 (4)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease, COPDStudies 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 660 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00496470
Sponsor's protocol ID: D5892C00015
Other IDs: Eudract no:2006-006796-21
Status last verified: Oct 2012
First submitted: 3 Jul 2007
Last updated: 9 Nov 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

Nielsen R, Kankaanranta H, Bjermer L, Lange P, Arnetorp S, Hedegaard M, Stenling A, Mittmann N. Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries. Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.
PubMed 23856511
Mittmann N, Hernandez P, Mellstrom C, Brannman L, Welte T. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. Pharmacoeconomics. 2011 May;29(5):403-14. doi: 10.2165/11590380-000000000-00000.
PubMed 21504240
Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.
PubMed 19897551
Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.
PubMed 19644045

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler®) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva®) 18 µg One Inhalation Once Daily
ClinicalTrials.gov ID: NCT00496470
Acronym / sponsor ID: D5892C00015
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 660 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 4 Jul 2007 (estimated)
Results: Posted 9 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
Symbicort+TIO	Active comparator	Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug)Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
Spiriva® + Placebo Turbuhaler	Active comparator	Drug: Spiriva (tiotropium bromide 18ug)Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

>=40 years of age, diagnosed COPD with symptoms >=2 years, pre-bronchodilatory FEV1 <=50% of PN

Key exclusion criteria (1 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
Symbicort (budesonide/formoterol turbuhaler 320/9ug)Symbicort (budesonide/formoterol turbuhaler 320/9ug)	Drug	Symbicort+TIO
Spiriva (tiotropium bromide 18ug)Spiriva (tiotropium bromide 18ug)	Drug	Spiriva® + Placebo Turbuhaler

Primary outcome

Forced Expiratory Volume in 1 Second (FEV1) Pre-dose
Time frame: Baseline to 12 weeks
Change in the pre-dose FEV1from baseline to week 12 (calculated as a mean using all available data of treatment period between week 1 and week 12)

36 secondary outcomes

Forced Expiratory Volume in 1 Second (FEV1) 5 Min Post-dose
Time frame: Baseline to 12 weeks
Forced Expiratory Volume in 1 Second (FEV1) 60 Min Post-dose
Time frame: Baseline to 12 weeks
Forced Vital Capacity (FVC) Pre-dose
Time frame: Baseline to 12 weeks
Forced Vital Capacity (FVC) 5 Minutes Post-dose
Time frame: Baseline to 12 weeks
Forced Vital Capacity (FVC) 60 Minutes Post-dose
Time frame: Baseline to 12 weeks
Inspiratory Capacity (IC) Pre-dose
Time frame: Baseline to 12 weeks
Inspiratory Capacity (IC) 60 Minutes Post-dose
Time frame: Baseline to 12 weeks
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score
Time frame: Baseline and 12 weeks
Morning Peak Expiratory Flow (PEF) Pre-dose
Time frame: Baseline to 12 weeks
Evening Peak Expiratory Flow (PEF) Pre-dose
Time frame: Baseline to 12 weeks
Morning Peak Expiratory Flow (PEF) 5 Min Post-dose
Time frame: Baseline to 12 weeks
Morning Peak Expiratory Flow (PEF) 15 Min Post-dose
Time frame: Baseline to 12 weeks
Morning Diary FEV1 Pre-dose
Time frame: Baseline to 12 weeks
Evening Diary FEV1, Pre-dose
Time frame: Baseline to 12 weeks
Morning Diary FEV1, 5 Minutes Post-dose
Time frame: Baseline to 12 weeks
Morning Diary FEV1, 15 Minutes Post-dose
Time frame: Baseline to 12 weeks
Global Chest Symptoms Questionnaire (GCSQ) Score, Pre-dose
Time frame: Baseline to 12 weeks
GCSQ Score, 5 Minutes Post-dose
Time frame: Baseline to 12 weeks
GCSQ Score, 15 Minutes Post-dose
Time frame: Baseline to 12 weeks
Capacity of Day Living in the Morning (CDLM) Score
Time frame: Baseline to 12 weeks
Use of Rescue Medication, Night
Time frame: Baseline to 12 weeks
Use of Rescue Medication, Morning
Time frame: Baseline to 12 weeks
Use of Rescue Medication, Day
Time frame: Baseline to 12 weeks
Use of Rescue Medication, Total
Time frame: Baseline to 12 weeks
COPD Symptoms, Breathing Score
Time frame: Baseline to 12 weeks
COPD Symptoms, Sleeping Score
Time frame: Baseline to 12 weeks
COPD Symptoms, Chest Score
Time frame: Baseline to 12 weeks
COPD Symptoms, Cough Score
Time frame: Baseline to 12 weeks
Severe COPD Exacerbations
Time frame: 12 weeks
Serum High-sensitivity C-reactive Protein (hsCRP)
Time frame: Baseline to 12 weeks
Serum Interleukin 6 (IL-6)
Time frame: Baseline to 12 weeks
Serum Interleukin 8 (IL-8)
Time frame: Baseline to 12 weeks
Serum Monocyte Chemoattractant Protein-1 (MCP-1)
Time frame: Baseline to 12 weeks
Serum Soluble Tumor Necrosis Factor-alpha (sTNF-alpha)
Time frame: Baseline to 12 weeks
Serum Tumor Necrosis Factor-alpha (TNF-alpha)
Time frame: Baseline to 12 weeks
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
Time frame: Baseline to 12 weeks

Results and safety

Results posted to the registry on 9 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Symbicort+Tiotropium	329	303
Placebo+Tiotropium	331	302

Primary outcome: Forced Expiratory Volume in 1 Second (FEV1) Pre-dose

Time frame: Baseline to 12 weeks. Mean (Standard Deviation). Unit: Liters

Measure	Symbicort+Tiotropium n = 323	Placebo+Tiotropium n = 327
Value	0.064 (0.198)	-0.001 (0.168)

Population analysed: Full analysis set (FAS) was performed and was based on data from all subjects who were randomized, took at least 1 dose of study medication, and contributed sufficient data for calculation of this outcome Measure.

36 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Symbicort+Tiotropium	10 of 329 (3%)	0 of 329 (0%)	Not reported
Placebo+Tiotropium	16 of 330 (4.8%)	0 of 330 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23856511Nielsen R, Kankaanranta H, Bjermer L, Lange P, Arnetorp S, Hedegaard M, Stenling A, Mittmann N. Cost effectiveness of adding budesonide/formoterol to tiotropium in COPD in four Nordic countries. Respir Med. 2013 Nov;107(11):1709-21. doi: 10.1016/j.rmed.2013.06.007. Epub 2013 Jul 13.
Derived from this study: PubMed 21504240Mittmann N, Hernandez P, Mellstrom C, Brannman L, Welte T. Cost effectiveness of budesonide/formoterol added to tiotropium bromide versus placebo added to tiotropium bromide in patients with chronic obstructive pulmonary disease: Australian, Canadian and Swedish healthcare perspectives. Pharmacoeconomics. 2011 May;29(5):403-14. doi: 10.2165/11590380-000000000-00000.
Derived from this study: PubMed 19897551Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.
Derived from this study: PubMed 19644045Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. doi: 10.1164/rccm.200904-0492OC. Epub 2009 Jul 30.

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Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

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 R&D Lund

Tobias Welte, MD principal investigator

Hannover Medical School

93 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in France, Slovakia, Hungary, Canada, Australia and 4 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. 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 9 Nov 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) Pre-dose (time frame: Baseline 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 NCT00496470, which also lists 4 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 9 Nov 2012.