AsthmaPhase 4NCT00315744

Viapaed Study In Children And Adolescents With Asthma

A Phase 4 study testing Salmeterol/fluticasone, Fluticasone propionate and Salbutamol in people with Asthma, run by GlaxoSmithKline at 98 sites in Germany.

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

Who is it for?: Ages 4 to 16 years
Conditions the study is for: Asthma
What is being tested?: Salmeterol/fluticasone, Fluticasone propionate and Salbutamol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 285 participants
Where: 98 sitesGermany
Study dates: 4 Nov 2004to 12 Apr 2007
Phase: Phase 4
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 4 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children aged 4 to 16 years with an established history of perennial asthma.
Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
Subjects/guardians who have given written informed consent to participate in the study.
Subjects /guardians who are able to understand and complete a diary record card (DRC).

Show all 9Show fewer

Subjects who are able to use a Mini-Wright Peak Flow meter.
Sexually active female adolescents must use adequate contraception.
Willingness to refrain from any other controller medication (including anti-leukotrienes) or from regular use of short-acting beta agonists or anticholinergics during the treatment period.

Who cannot join

None listed.

Trial locations and contacts

98 sites in 1 country.

City, postcode or hospital

98 sites in 1 country

Germany98 sites

GSK Investigational Site
Aachen, North Rhine-Westphalia, 52072
GSK Investigational Site
Bad Krozingen, Baden-Wurttemberg, 79189
GSK Investigational Site
Belm, Lower Saxony, 49191
GSK Investigational Site
Berlin, 10365
GSK Investigational Site
Berlin, 10785
GSK Investigational Site
Berlin, 10965
GSK Investigational Site
Berlin, 10967
GSK Investigational Site
Berlin, 10997
GSK Investigational Site
Berlin, 12161
GSK Investigational Site
Berlin, 12167
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Berlin, 13347
GSK Investigational Site
Berlin, 13355
GSK Investigational Site
Berlin, 14163
GSK Investigational Site
Bielefeld, North Rhine-Westphalia, 33617
GSK Investigational Site
Bobingen, Bavaria, 86399
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44789
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44791
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44795
GSK Investigational Site
Bochum, North Rhine-Westphalia, 44866
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357
GSK Investigational Site
Bottrop, North Rhine-Westphalia, 46242
GSK Investigational Site
Braunfels, Hesse, 35619
GSK Investigational Site
Cossebaude, Saxony, 01462
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Döbeln, Saxony, 04720
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137
GSK Investigational Site
Dresden, Saxony, 01067
GSK Investigational Site
Dresden, Saxony, 01169
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47137
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40599
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Euskirchen, North Rhine-Westphalia, 53879
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944
GSK Investigational Site
Forchheim, Bavaria, 91301
GSK Investigational Site
Frankfurt (Oder), Brandenburg, 15236
GSK Investigational Site
Frankfurt am Main, Hesse, 60316
GSK Investigational Site
Freising, Bavaria, 85354
GSK Investigational Site
Friedrichsfelde, State of Berlin, 10315
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33332
GSK Investigational Site
Halle, North Rhine-Westphalia, 33790
GSK Investigational Site
Hamburg, 22045
GSK Investigational Site
Hamburg, 22415
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Harrislee, Schleswig-Holstein, 24955
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69115
GSK Investigational Site
Kassel, Hesse, 34121
GSK Investigational Site
Kaufbeuren, Bavaria, 87600
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Kempen, North Rhine-Westphalia, 47906
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068
GSK Investigational Site
Konstanz, Baden-Wurttemberg, 78464
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47389
GSK Investigational Site
Lauf, Bavaria, 91207
GSK Investigational Site
Leipzig, Saxony, 04279
GSK Investigational Site
Leipzig, Saxony, 04317
GSK Investigational Site
Lüneburg, Lower Saxony, 21339
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55127
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427
GSK Investigational Site
Munich, Bavaria, 80337
GSK Investigational Site
Munich, Bavaria, 80939
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41462
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41469
GSK Investigational Site
Niedernhausen, Hesse, 65527
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Nuremberg, Bavaria, 90449
GSK Investigational Site
Nuremberg, Bavaria, 90473
GSK Investigational Site
Oberhausen, North Rhine-Westphalia, 46145
GSK Investigational Site
Olching, Bavaria, 82140
GSK Investigational Site
Osnabrück, Lower Saxony, 49082
GSK Investigational Site
Pegnitz, Bavaria, 91257
GSK Investigational Site
Pfullendorf, Baden-Wurttemberg, 88630
GSK Investigational Site
Remscheid, North Rhine-Westphalia, 42899
GSK Investigational Site
Rosenheim, Bavaria, 83026
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Schwedt, Brandenburg, 16303
GSK Investigational Site
Schwetzingen, Baden-Wurttemberg, 68723
GSK Investigational Site
Sinsheim, Baden-Wurttemberg, 74889
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70499
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532
GSK Investigational Site
Villingen-Schwenningen, Baden-Wurttemberg, 78056
GSK Investigational Site
Welzheim, Baden-Wurttemberg, 73642
GSK Investigational Site
Wesel, North Rhine-Westphalia, 46483
GSK Investigational Site
Wetzlar, Hesse, 35576
GSK Investigational Site
Wiesbaden, Hesse, 65205
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877
GSK Investigational Site
Wurzen, Saxony, 04808

Other trials in Germany

About this study

Official title: Steroid-sparing Management of the Salmeterol/Fluticasone 50/100µg b.i.d. Combination Compared to Fluticasone 200µg b.i.d. in Children and Adolescents With Moderate Asthma

Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an adjustment of their asthma therapy. Current guidelines suggest that the treatment options are either an increased dose of inhaled corticosteroid or the addition of other therapy such as a long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to high dose ICS therapy are growth retardation and the suppression of the hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that a combination product that included a LABA as well as the ICS allowed to reduce the steroid dose and was still at least as effective in achieving asthma control as treatment with a higher dose of ICS. These treatment options shall be compared in the present study. Children who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of eight weeks.

Conditions: Asthma
Being tested: Salmeterol/fluticasone, Fluticasone propionate, Salbutamol
Keywords: moderate asthma, fluticasone, children, salmeterol, steroid-sparing, Asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Salmeterol/fluticasoneDrug
Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.
Fluticasone propionateDrug
Also called Salmeterol, SERETIDE
Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
SalbutamolDrug
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.

Study groups in NCT00315744
Study group	Role	What they receive
Subjects receiving salmeterol/fluticasone	Experimental	Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo. Receives: Drug: Salmeterol/fluticasone; Drug: Salbutamol
Subjects receiving fluticasone	Active comparator	Eligible subjects will receive 60 individual fluticasone 100 microgram doses each. Receives: Drug: Fluticasone propionate; Drug: Salbutamol

What is being measured

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

Change from Baseline in mean morning peak expiratory flow (PEF)
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter and will be documented daily at morning in the diary of subjects
Measured: Baseline up to Week 8

Secondary outcomes (11)

Daily Asthma symptom score
Asthma symptoms will be recorded separately for night and day using 2 symptom scores. Symptoms included will be coughing, wheezing, shortness of breath, feeling of tightness in the chest and nocturnal waking due to 1 or more of these symptoms. Score will range from 0-4 where 0 = no complaints and 4= person could not sleep due to asthma symptoms.
Measured: Up to Week 8
Number of calendar days without asthma symptoms
Number of calendar days without asthma symptoms will be defined as the sum of all days for which the patient documented an asthma symptom score of 0 (no complaints) for the day and the previous night.
Measured: Up to Week 8
Number of necessary administrations of salbutamol
The number of necessary administrations of salbutamol will be documented daily by subjects in the diary.
Measured: Up to Week 8
Number of weeks with good asthma control
One week of well controlled asthma will be defined by fulfilling the following criteria: at least 2 of the following criteria (type A): symptoms with a symptom score >1 on at most 2 days, use of rescue medication maximally 4 x per week, morning PEF daily >=80% of the predicted normal value and all the following criteria (type B): no nocturnal waking due to bronchial asthma, no exacerbations, no out-patient or hospitalized emergency treatment due to asthma, no adverse events due to administration of the study medication which would have necessitated a change of treatment, no intolerance or refusal of study medication
Measured: Up to Week 8
Change in forced vital capacity (FVC) in % of reference value
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deep breath.
Measured: Up to Week 8
Change in forced expiratory volume in 1 second (FEV1) in % of reference value
FEV1 is the volume of air exhaled under forced conditions in 1 second.
Measured: Up to Week 8
Change in peak expiratory flow rate (PEFR) in % of reference value
PEFR is a person's maximum speed of expiration.
Measured: Up to Week 8
Change in mean morning peak flow in % of reference value
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter
Measured: Up to Week 8
Percentage of subjects with a peak flow variability of 20%
Morning versus evening peak flow will be calculated and compared.
Measured: Up to Week 8
Number of subject withdrawals due to asthma exacerbations
Asthma exacerbations are acute or sub acute episodes, which are characterized by a progressive increase in one or more typical asthma symptoms.
Measured: Up to Week 8
Number of subjects with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Week 8

Timeline

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

4 Nov 200412 Apr 2007

First posted19 Apr 2006 (estimated)
Study start4 Nov 2004
Primary completion12 Apr 2007
Study completion12 Apr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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
Enrolment: 285 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00315744
Sponsor's protocol ID: 102318
Status last verified: Oct 2017
First submitted: 17 Apr 2006
Last updated: 19 Oct 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Gappa M, Zachgo W, von Berg A, Kamin W, Stern-Strater C, Steinkamp G; VIAPAED Study Group. Add-on salmeterol compared to double dose fluticasone in pediatric asthma: a double-blind, randomized trial (VIAPAED). Pediatr Pulmonol. 2009 Nov;44(11):1132-42. doi: 10.1002/ppul.21120.
PubMed 19824054

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Steroid-sparing Management of the Salmeterol/Fluticasone 50/100µg b.i.d. Combination Compared to Fluticasone 200µg b.i.d. in Children and Adolescents With Moderate Asthma
ClinicalTrials.gov ID: NCT00315744
Acronym / sponsor ID: 102318
Conditions: Asthma
Keywords: moderate asthma, fluticasone, children, salmeterol, steroid-sparing, Asthma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 285 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Nov 2004 (actual)
Primary completion: 12 Apr 2007 (actual)
Study completion: 12 Apr 2007 (actual)
First posted: 19 Apr 2006 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Number of arms: 2

Arm	Type	Receives
Subjects receiving salmeterol/fluticasone	Experimental	Drug: Salmeterol/fluticasone, Drug: SalbutamolEligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.
Subjects receiving fluticasone	Active comparator	Drug: Fluticasone propionate, Drug: SalbutamolEligible subjects will receive 60 individual fluticasone 100 microgram doses each.

Who may qualify

Ages: 4 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

Children aged 4 to 16 years with an established history of perennial asthma.
Subjects who are treated with an inhaled corticosteroid according to BDP (budesonide) 200-400 µg/day or equivalent during the last 4 weeks before run-in.
15 minutes after inhaling 200µg of salbutamol, reversible increase in FEV1 of at least 12% of the pre-dose value.
Willingness to substitute previous controller medication on the twice daily inhalation of fluticasone 100µg bid via DISKUS®.
Subjects/guardians who have given written informed consent to participate in the study.

Key exclusion criteria (0 listed)

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
Salmeterol/fluticasoneSalmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.	Drug	Subjects receiving salmeterol/fluticasone
Fluticasone propionateAlso: Salmeterol, SERETIDEFluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.	Drug	Subjects receiving fluticasone
SalbutamolSalbutamol metered dose inhaler will be provided to all subjects as a rescue medication.	Drug	Subjects receiving fluticasone, Subjects receiving salmeterol/fluticasone

Primary outcome

Change from Baseline in mean morning peak expiratory flow (PEF)
Time frame: Baseline up to Week 8
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter and will be documented daily at morning in the diary of subjects

11 secondary outcomes

Daily Asthma symptom score
Time frame: Up to Week 8
Number of calendar days without asthma symptoms
Time frame: Up to Week 8
Number of necessary administrations of salbutamol
Time frame: Up to Week 8
Number of weeks with good asthma control
Time frame: Up to Week 8
Change in forced vital capacity (FVC) in % of reference value
Time frame: Up to Week 8
Change in forced expiratory volume in 1 second (FEV1) in % of reference value
Time frame: Up to Week 8
Change in peak expiratory flow rate (PEFR) in % of reference value
Time frame: Up to Week 8
Change in mean morning peak flow in % of reference value
Time frame: Up to Week 8
Percentage of subjects with a peak flow variability of 20%
Time frame: Up to Week 8
Number of subject withdrawals due to asthma exacerbations
Time frame: Up to Week 8
Number of subjects with adverse events (AEs)
Time frame: Up to Week 8

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 19 Oct 2017.
Background: PubMed 19824054Gappa M, Zachgo W, von Berg A, Kamin W, Stern-Strater C, Steinkamp G; VIAPAED Study Group. Add-on salmeterol compared to double dose fluticasone in pediatric asthma: a double-blind, randomized trial (VIAPAED). Pediatr Pulmonol. 2009 Nov;44(11):1132-42. doi: 10.1002/ppul.21120.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Asthma

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RecruitingObservational study
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Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
RecruitingObservational study
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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.

GSK Clinical Trials study director

GlaxoSmithKline

98 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Salmeterol/fluticasone, Fluticasone propionate and Salbutamol in people with Asthma, run by GlaxoSmithKline at 98 sites in Germany.

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 9 inclusion and 0 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Germany. 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?

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?

Change from Baseline in mean morning peak expiratory flow (PEF) (time frame: Baseline up to Week 8). 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 NCT00315744, 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 19 Oct 2017.