search
Back to results

Viapaed Study In Children And Adolescents With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Salmeterol/fluticasone
Fluticasone propionate
Salbutamol
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring moderate asthma, fluticasone, children, salmeterol, steroid-sparing, Asthma

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subjects receiving salmeterol/fluticasone

Subjects receiving fluticasone

Arm Description

Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.

Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
Number of necessary administrations of salbutamol
The number of necessary administrations of salbutamol will be documented daily by subjects in the diary.
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
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.
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.
Change in peak expiratory flow rate (PEFR) in % of reference value
PEFR is a person's maximum speed of expiration.
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
Percentage of subjects with a peak flow variability of 20%
Morning versus evening peak flow will be calculated and compared.
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.
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.

Full Information

First Posted
April 17, 2006
Last Updated
October 18, 2017
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00315744
Brief Title
Viapaed Study In Children And Adolescents With Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 4, 2004 (Actual)
Primary Completion Date
April 12, 2007 (Actual)
Study Completion Date
April 12, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
moderate asthma, fluticasone, children, salmeterol, steroid-sparing, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects receiving salmeterol/fluticasone
Arm Type
Experimental
Arm Description
Eligible subjects will receive 60 individual doses of the salmeterol 50 microgram/ fluticasone 100 microgram combination. Subjects will also receive placebo.
Arm Title
Subjects receiving fluticasone
Arm Type
Active Comparator
Arm Description
Eligible subjects will receive 60 individual fluticasone 100 microgram doses each.
Intervention Type
Drug
Intervention Name(s)
Salmeterol/fluticasone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Other Intervention Name(s)
Salmeterol, SERETIDE
Intervention Description
Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.
Intervention Type
Drug
Intervention Name(s)
Salbutamol
Intervention Description
Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
Primary Outcome Measure Information:
Title
Change from Baseline in mean morning peak expiratory flow (PEF)
Description
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
Time Frame
Baseline up to Week 8
Secondary Outcome Measure Information:
Title
Daily Asthma symptom score
Description
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.
Time Frame
Up to Week 8
Title
Number of calendar days without asthma symptoms
Description
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.
Time Frame
Up to Week 8
Title
Number of necessary administrations of salbutamol
Description
The number of necessary administrations of salbutamol will be documented daily by subjects in the diary.
Time Frame
Up to Week 8
Title
Number of weeks with good asthma control
Description
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
Time Frame
Up to Week 8
Title
Change in forced vital capacity (FVC) in % of reference value
Description
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deep breath.
Time Frame
Up to Week 8
Title
Change in forced expiratory volume in 1 second (FEV1) in % of reference value
Description
FEV1 is the volume of air exhaled under forced conditions in 1 second.
Time Frame
Up to Week 8
Title
Change in peak expiratory flow rate (PEFR) in % of reference value
Description
PEFR is a person's maximum speed of expiration.
Time Frame
Up to Week 8
Title
Change in mean morning peak flow in % of reference value
Description
The PEF is a person's maximum speed of expiration. PEF will be measured using a mini wright peak flow meter
Time Frame
Up to Week 8
Title
Percentage of subjects with a peak flow variability of 20%
Description
Morning versus evening peak flow will be calculated and compared.
Time Frame
Up to Week 8
Title
Number of subject withdrawals due to asthma exacerbations
Description
Asthma exacerbations are acute or sub acute episodes, which are characterized by a progressive increase in one or more typical asthma symptoms.
Time Frame
Up to Week 8
Title
Number of subjects with adverse events (AEs)
Description
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.
Time Frame
Up to Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bad Krozingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79189
Country
Germany
Facility Name
GSK Investigational Site
City
Boennigheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74357
Country
Germany
Facility Name
GSK Investigational Site
City
Ettenheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77955
Country
Germany
Facility Name
GSK Investigational Site
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
GSK Investigational Site
City
Kehl
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77694
Country
Germany
Facility Name
GSK Investigational Site
City
Konstanz
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
78464
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
GSK Investigational Site
City
Pfullendorf
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88630
Country
Germany
Facility Name
GSK Investigational Site
City
Schwaebisch-Hall
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74523
Country
Germany
Facility Name
GSK Investigational Site
City
Schwetzingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68723
Country
Germany
Facility Name
GSK Investigational Site
City
Sinsheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74889
Country
Germany
Facility Name
GSK Investigational Site
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70469
Country
Germany
Facility Name
GSK Investigational Site
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70499
Country
Germany
Facility Name
GSK Investigational Site
City
Tauberbischofsheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
97941
Country
Germany
Facility Name
GSK Investigational Site
City
Tuttlingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
78532
Country
Germany
Facility Name
GSK Investigational Site
City
Villingen-Schwenningen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
78056
Country
Germany
Facility Name
GSK Investigational Site
City
Welzheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
73642
Country
Germany
Facility Name
GSK Investigational Site
City
Bobingen
State/Province
Bayern
ZIP/Postal Code
86399
Country
Germany
Facility Name
GSK Investigational Site
City
Forchheim
State/Province
Bayern
ZIP/Postal Code
91301
Country
Germany
Facility Name
GSK Investigational Site
City
Freising
State/Province
Bayern
ZIP/Postal Code
85354
Country
Germany
Facility Name
GSK Investigational Site
City
Kaufbeuren
State/Province
Bayern
ZIP/Postal Code
87600
Country
Germany
Facility Name
GSK Investigational Site
City
Lauf
State/Province
Bayern
ZIP/Postal Code
91207
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80337
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
80939
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90449
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90473
Country
Germany
Facility Name
GSK Investigational Site
City
Olching
State/Province
Bayern
ZIP/Postal Code
82140
Country
Germany
Facility Name
GSK Investigational Site
City
Pegnitz
State/Province
Bayern
ZIP/Postal Code
91257
Country
Germany
Facility Name
GSK Investigational Site
City
Rosenheim
State/Province
Bayern
ZIP/Postal Code
83026
Country
Germany
Facility Name
GSK Investigational Site
City
Friedrichsfelde
State/Province
Berlin
ZIP/Postal Code
10315
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt/Oder
State/Province
Brandenburg
ZIP/Postal Code
15236
Country
Germany
Facility Name
GSK Investigational Site
City
Schwedt
State/Province
Brandenburg
ZIP/Postal Code
16303
Country
Germany
Facility Name
GSK Investigational Site
City
Braunfels
State/Province
Hessen
ZIP/Postal Code
35619
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60316
Country
Germany
Facility Name
GSK Investigational Site
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34121
Country
Germany
Facility Name
GSK Investigational Site
City
Niedernhausen
State/Province
Hessen
ZIP/Postal Code
65527
Country
Germany
Facility Name
GSK Investigational Site
City
Wetzlar
State/Province
Hessen
ZIP/Postal Code
35576
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65205
Country
Germany
Facility Name
GSK Investigational Site
City
Belm
State/Province
Niedersachsen
ZIP/Postal Code
49191
Country
Germany
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
GSK Investigational Site
City
Lueneburg
State/Province
Niedersachsen
ZIP/Postal Code
21339
Country
Germany
Facility Name
GSK Investigational Site
City
Osnabrueck
State/Province
Niedersachsen
ZIP/Postal Code
49082
Country
Germany
Facility Name
GSK Investigational Site
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52072
Country
Germany
Facility Name
GSK Investigational Site
City
Bielefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33617
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44789
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44795
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44866
Country
Germany
Facility Name
GSK Investigational Site
City
Bottrop
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46242
Country
Germany
Facility Name
GSK Investigational Site
City
Detmold
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32756
Country
Germany
Facility Name
GSK Investigational Site
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
Facility Name
GSK Investigational Site
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
GSK Investigational Site
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40599
Country
Germany
Facility Name
GSK Investigational Site
City
Duisburg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47137
Country
Germany
Facility Name
GSK Investigational Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
GSK Investigational Site
City
Euskirchen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
53879
Country
Germany
Facility Name
GSK Investigational Site
City
Guetersloh
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33332
Country
Germany
Facility Name
GSK Investigational Site
City
Halle
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33790
Country
Germany
Facility Name
GSK Investigational Site
City
Kempen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47906
Country
Germany
Facility Name
GSK Investigational Site
City
Kleve-Materborn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47533
Country
Germany
Facility Name
GSK Investigational Site
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47389
Country
Germany
Facility Name
GSK Investigational Site
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32427
Country
Germany
Facility Name
GSK Investigational Site
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41462
Country
Germany
Facility Name
GSK Investigational Site
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41469
Country
Germany
Facility Name
GSK Investigational Site
City
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46145
Country
Germany
Facility Name
GSK Investigational Site
City
Remscheid
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42899
Country
Germany
Facility Name
GSK Investigational Site
City
Wesel
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46483
Country
Germany
Facility Name
GSK Investigational Site
City
Willich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47877
Country
Germany
Facility Name
GSK Investigational Site
City
Koblenz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
56068
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55127
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54294
Country
Germany
Facility Name
GSK Investigational Site
City
Cossebaude
State/Province
Sachsen
ZIP/Postal Code
01462
Country
Germany
Facility Name
GSK Investigational Site
City
Doebeln
State/Province
Sachsen
ZIP/Postal Code
04720
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01067
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01169
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04279
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04317
Country
Germany
Facility Name
GSK Investigational Site
City
Wurzen
State/Province
Sachsen
ZIP/Postal Code
04808
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24944
Country
Germany
Facility Name
GSK Investigational Site
City
Geesthacht
State/Province
Schleswig-Holstein
ZIP/Postal Code
21502
Country
Germany
Facility Name
GSK Investigational Site
City
Harrislee
State/Province
Schleswig-Holstein
ZIP/Postal Code
24955
Country
Germany
Facility Name
GSK Investigational Site
City
Neuhaus am Rennweg
State/Province
Thueringen
ZIP/Postal Code
98724
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10365
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10785
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10965
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10997
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12167
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13355
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14163
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22045
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
19824054
Citation
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.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102318
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102318
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102318
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102318
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102318
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
102318
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Viapaed Study In Children And Adolescents With Asthma

We'll reach out to this number within 24 hrs