6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old

NCT ID: NCT01462344

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 6250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-17
• Study Completion Date: 2015-11-03

Brief Summary

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in children 4-11 years old taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

Detailed Description

Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in May of 2016. This is the final update, as this study is complete.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ADVAIR 100/50mcg

fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

Group Type: EXPERIMENTAL

ADVAIR 100/50mcg

Intervention Type: DRUG

fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

ADVAIR 250/50mcg

fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

Group Type: EXPERIMENTAL

ADVAIR 250/50mcg

Intervention Type: DRUG

fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

FLOVENT 100mcg

fluticasone propionate (100) twice daily (AM and PM) for 6 months

Group Type: ACTIVE_COMPARATOR

FLOVENT 100mcg

Intervention Type: DRUG

fluticasone propionate (100) twice daily (AM and PM) for 6 months

FLOVENT 250mcg

fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

Group Type: ACTIVE_COMPARATOR

FLOVENT 250mcg

Intervention Type: DRUG

fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

Interventions

ADVAIR 100/50mcg

fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

Intervention Type: DRUG

ADVAIR 250/50mcg

fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

Intervention Type: DRUG

FLOVENT 100mcg

fluticasone propionate (100) twice daily (AM and PM) for 6 months

Intervention Type: DRUG

FLOVENT 250mcg

fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

Intervention Type: DRUG

Other Intervention Names

FSC 100/50; FSC 250/50; FP 100; FP 250

Eligibility Criteria

Inclusion Criteria

1. Consent to participate in the study

2. Age 4-11 years old

3. Male or eligible female - Female subjects should not be enrolled if they are pregnant, lactating or plan to become pregnant during the time of study participation

4. Asthma diagnosis for at least 6 months

5. Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS

6. A history of clinical varicella infection or recipient of a varicella vaccine in countries where the product label includes a warning regarding more serious chickenpox infections in patients using corticosteroids.

7. History of at least once occurrence of asthma exacerbation within the prior 12 months

8. Currently being treated for asthma and no change in asthma therapy for the last 4 weeks (Eligible subjects include: subjects with use of short-acting beta-agonist, leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not well-controlled; subjects on low-dose ICS monotherapy whose asthma is not well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS monotherapy whose asthma is either controlled or not well-controlled; and subjects on medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)

Exclusion Criteria

1. History of life-threatening asthma

2. Unstable asthma

3. Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms

4. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.

5. Respiratory infection

6. Subjects with only exercise-induced asthma

7. An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months

8. Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months

9. Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system

10. Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements

11. Participation in an interventional study or used any investigational drug for any disease state within the last 30 days

12. Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication

13. Severe hypersensitivity to cow's milk proteins

14. Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics

15. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)

16. Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.

17. A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Seoul, , South Korea

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Dnipropetrovsk, , Ukraine

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Capital Federal, , Argentina

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San Miguel de Tucumán, , Argentina

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Westmead, New South Wales, Australia

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Auchenflower, Queensland, Australia

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Subiaco, Western Australia, Australia

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Parkville, , Australia

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Randwick, , Australia

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Bregenz, , Austria

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Feldkirch, , Austria

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Vienna, , Austria

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Antwerp, , Belgium

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Brussels, , Belgium

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Leuven, , Belgium

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Natoye, , Belgium

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Blagoevgrad, , Bulgaria

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Pleven, , Bulgaria

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Plovdiv, , Bulgaria

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Rousse, , Bulgaria

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Rousse, , Bulgaria

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Sevlievo, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Varna, , Bulgaria

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Varna, , Bulgaria

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Veliko Tarnovo, , Bulgaria

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Vidin, , Bulgaria

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Brampton, Ontario, Canada

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Burlington, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Santiago, , Chile

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Valdivia, , Chile

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Viña del Mar, , Chile

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Medellín, , Colombia

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Čakovec, , Croatia

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Dubrovnik, , Croatia

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Jastrebarsko, , Croatia

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Rijeka, , Croatia

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Split, , Croatia

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Zagreb, , Croatia

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Brno, , Czechia

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Brno, , Czechia

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Česká Lípa, , Czechia

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Olomouc, , Czechia

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Prague, , Czechia

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Bruchsal, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

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Augsburg, Bavaria, Germany

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Fürth, Bavaria, Germany

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Höchstadt an der Aisch, Bavaria, Germany

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Weißenhorn, Bavaria, Germany

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Frankfurt am Main, Hesse, Germany

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Bad Pyrmont, Lower Saxony, Germany

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Bad Lippspringe, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Detmold, North Rhine-Westphalia, Germany

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Hagen, North Rhine-Westphalia, Germany

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Kleve-Materborn, North Rhine-Westphalia, Germany

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Neuss, North Rhine-Westphalia, Germany

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Telgte, North Rhine-Westphalia, Germany

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Teuchern, Saxony-Anhalt, Germany

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Geesthacht, Schleswig-Holstein, Germany

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Reinfeld, Schleswig-Holstein, Germany

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Berlin, , Germany

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Berlin, , Germany

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Baja, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Miskolc, , Hungary

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Nagykanizsa, , Hungary

GSK Investigational Site

Ráckeve, , Hungary

GSK Investigational Site

Szekszárd, , Hungary

GSK Investigational Site

Törökbálint, , Hungary

GSK Investigational Site

Rome, Lazio, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Brescia, , Italy

GSK Investigational Site

Messina, , Italy

GSK Investigational Site

Milan, , Italy

GSK Investigational Site

Palermo, , Italy

GSK Investigational Site

Roma, , Italy

GSK Investigational Site

Sesto San Giovanni, , Italy

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Riga, , Latvia

GSK Investigational Site

Tukums, , Latvia

GSK Investigational Site

Kaunas, , Lithuania

GSK Investigational Site

Kaunas, , Lithuania

GSK Investigational Site

Utena, , Lithuania

GSK Investigational Site

Vilnius, , Lithuania

GSK Investigational Site

Vilnius, , Lithuania

GSK Investigational Site

Ipoh, , Malaysia

GSK Investigational Site

Kuala Lumpur, , Malaysia

GSK Investigational Site

Kuching, , Malaysia

GSK Investigational Site

Seremban, Negeri Sembilan, , Malaysia

GSK Investigational Site

Sibu, , Malaysia

GSK Investigational Site

Sungai Buloh, , Malaysia

GSK Investigational Site

Guadalajara, Jalisco, Mexico

GSK Investigational Site

Monterrey, Nuevo León, Mexico

GSK Investigational Site

Chihuahua City, , Mexico

GSK Investigational Site

Huixquilucan, , Mexico

GSK Investigational Site

Monterrey, , Mexico

GSK Investigational Site

Miraflores, Lima region, Peru

GSK Investigational Site

San Martín de Porres, Lima region, Peru

GSK Investigational Site

Santiago de Surco, Lima region, Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

Lima, , Peru

GSK Investigational Site

San Borja, , Peru

GSK Investigational Site

Dasmariñas, Cavite, , Philippines

GSK Investigational Site

Davao City, , Philippines

GSK Investigational Site

Pulilan, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Bialystok, , Poland

GSK Investigational Site

Cieszyn, , Poland

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Jelenia Góra, , Poland

GSK Investigational Site

Karpacz, , Poland

GSK Investigational Site

Koszalin, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Lodz, , Poland

GSK Investigational Site

Lubin, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Lublin, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Rzeszów, , Poland

GSK Investigational Site

Sandomierz, , Poland

GSK Investigational Site

Skarżysko-Kamienna, , Poland

GSK Investigational Site

Skierniewice, , Poland

GSK Investigational Site

Szczecin, , Poland

GSK Investigational Site

Szczecin, , Poland

GSK Investigational Site

Tarnów, , Poland

GSK Investigational Site

Warsaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Zabrze, , Poland

GSK Investigational Site

Zabrze, , Poland

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Sibiu, , Romania

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Nizhny Novgorod, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saratov, , Russia

GSK Investigational Site

St'Petersburg, , Russia

GSK Investigational Site

Tomsk, , Russia

GSK Investigational Site

Voronezh, , Russia

GSK Investigational Site

Yaroslavl, , Russia

GSK Investigational Site

Belgrade, , Serbia

GSK Investigational Site

Čačak, , Serbia

GSK Investigational Site

Niš, , Serbia

GSK Investigational Site

Novi Sad, , Serbia

GSK Investigational Site

Užice, , Serbia

GSK Investigational Site

Martin, , Slovakia

GSK Investigational Site

Nitra, , Slovakia

GSK Investigational Site

Trnava, , Slovakia

GSK Investigational Site

Welkom, Free State, South Africa

GSK Investigational Site

Benoni, Gauteng, South Africa

GSK Investigational Site

Krugersdorp, Gauteng, South Africa

GSK Investigational Site

Pretoria, Gauteng, South Africa

GSK Investigational Site

Benoni, , South Africa

GSK Investigational Site

Cape Town, , South Africa

GSK Investigational Site

Cape Town, , South Africa

GSK Investigational Site

Cape Town, , South Africa

GSK Investigational Site

Cape Town, , South Africa

GSK Investigational Site

Claremont, , South Africa

GSK Investigational Site

Durban, , South Africa

GSK Investigational Site

Middelburg, , South Africa

GSK Investigational Site

Paarl, , South Africa

GSK Investigational Site

Pretoria, , South Africa

GSK Investigational Site

Pretoria, , South Africa

GSK Investigational Site

Thabazimbi, , South Africa

GSK Investigational Site

Cheongju-si, , South Korea

GSK Investigational Site

Gyeonggi-do, , South Korea

GSK Investigational Site

Gyeonggi-do, , South Korea

GSK Investigational Site

Gyeonggi-do, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kryvyi Rih, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

GSK Investigational Site

Lviv, , Ukraine

GSK Investigational Site

Odesa, , Ukraine

GSK Investigational Site

Odesa, , Ukraine

GSK Investigational Site

Poltava, , Ukraine

GSK Investigational Site

Simferopol, , Ukraine

GSK Investigational Site

Sumy, , Ukraine

GSK Investigational Site

Uzhhorod, , Ukraine

GSK Investigational Site

Zaporizhia, , Ukraine

GSK Investigational Site

Chesterfield, Derbyshire, United Kingdom

GSK Investigational Site

Cardiff, Glamorgan, United Kingdom

GSK Investigational Site

Newcastle upon Tyne, Northumberland, United Kingdom

GSK Investigational Site

Bath, Somerset, United Kingdom

GSK Investigational Site

Brighton, Sussex East, United Kingdom

GSK Investigational Site

Atherstone, Warwickshire, United Kingdom

GSK Investigational Site

Barry, , United Kingdom

GSK Investigational Site

Bexhill-on-Sea, , United Kingdom

GSK Investigational Site

Doncaster, , United Kingdom

GSK Investigational Site

Glasgow, , United Kingdom

GSK Investigational Site

Kent, , United Kingdom

GSK Investigational Site

Leicester, , United Kingdom

GSK Investigational Site

Macclesfield, , United Kingdom

GSK Investigational Site

Merseyside, , United Kingdom

GSK Investigational Site

Penzance, , United Kingdom

GSK Investigational Site

Peterborough, , United Kingdom

GSK Investigational Site

Stockton-on-Tees, , United Kingdom

GSK Investigational Site

Stoke-on-Trent, , United Kingdom

GSK Investigational Site

Surrey, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Bulgaria; Canada; Chile; Colombia; Croatia; Czechia; Germany; Hungary; Italy; Latvia; Lithuania; Malaysia; Mexico; Peru; Philippines; Poland; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Taiwan; Thailand; Ukraine; United Kingdom

References

Lee LA, Pedersen S, Pascoe SJ, Szefler SJ, Lenney W. No dose effect observed with chronic fluticasone propionate on growth velocity in children. Pediatr Allergy Immunol. 2021 Feb;32(2):377-381. doi: 10.1111/pai.13378. Epub 2020 Oct 26. No abstract available.

Reference Type: DERIVED

PMID: 32966707 (View on PubMed)

Stempel DA, Szefler SJ, Pedersen S, Zeiger RS, Yeakey AM, Lee LA, Liu AH, Mitchell H, Kral KM, Raphiou IH, Prillaman BA, Buaron KS, Yun Kirby S, Pascoe SJ; VESTRI Investigators. Safety of Adding Salmeterol to Fluticasone Propionate in Children with Asthma. N Engl J Med. 2016 Sep 1;375(9):840-9. doi: 10.1056/NEJMoa1606356.

Reference Type: DERIVED

PMID: 27579634 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

115358

Identifier Type: -

Identifier Source: org_study_id