Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids

NCT00353873 | Completed Phase 4 Results

• 1 other identifier: SAM104926
• Study Type: interventional
• Target: 506
• Locations: 12 countries
• Sites: 65

Brief Summary

This study will compare two treatment strategies (doubling the dose of inhaled steroids or adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50 one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.

Conditions

Asthma

Keywords

FLIXOTIDE; asthmatics children 4-11 years; SERETIDE; asthma-control

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Morning Peak Expiratory Flow (PEF) Over 12 Weeks in Intent-to-treat (ITT) Population

  PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in electronic diary record card (eDRC), performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using analysis of covariance (ANCOVA) adjusted for baseline PEF, country amalgamation, age, sex and treatment.

  Baseline; Week 1 up to Week 12

• Mean Change From Baseline in Morning PEF Over 12 Weeks in Per Protocol (PP) Population

  PEF is the maximum flow generated during expiration, as measured with a peak flow meter and recorded in eDRC, performed with maximal force and started after a full inspiration. The mean morning PEF measurement was constructed by calculating a simple mean for each participant over the interval Weeks 1 to 12. All PEF measurements were converted to the Wright/McKerow peak flow meter scale for the purposes of analyses. The change from Baseline is then calculated by subtracting the Baseline PEF values from the individual on-treatment values. Baseline was calculated as the mean of the values recorded on the seven days preceding randomization. The analysis was done using ANCOVA adjusted for baseline PEF, country amalgamation, age, sex and treatment.

  Baseline; Week 1 up to Week 12

Secondary Outcomes (2)

• Number of Participants Who Achieved 'Totally Controlled' (TC) Asthma

  Week 5 up to Week 12

• Number of Participants Who Achieved WC Asthma

  Week 5 up to Week 12

Study Arms (2)

Fluticasone propionate (FLIXOTIDE™)

ACTIVE COMPARATOR

Fluticasone propionate (FLIXOTIDE™) at a dose of 200μg twice daily

Drug: Fluticasone propionate

Fluticasone propionate/salmeterol (SERETIDE™)

EXPERIMENTAL

Salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100μg twice daily

Drug: Fluticasone propionate/salmeterol

Interventions

Fluticasone propionate DRUG

200μg twice daily

Fluticasone propionate (FLIXOTIDE™)

Fluticasone propionate/salmeterol DRUG

50/100μg twice daily

Also known as: Fluticasone propionate

Fluticasone propionate/salmeterol (SERETIDE™)

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A documented clinical history of asthma for a period of at least 6 months.
• A documented history (within 12 months of Visit 1) of airway reversibility of = 15% based either on Forced expiratory volume (FEV1) or PEF measured pre and post inhalation of 200 mcg salbutamol. (If no documented history of reversibility exists, patients must demonstrate a =15% reversibility at Visit 1).
• Receiving an inhaled corticosteroid at a medium dose (beclomethasone dipropionate HydroFluoroAlkane (HFA) non fine particle = 400-500 mcg/day or beclomethasone HFA fine particle = 200mcg/day, or budesonide =400 mcg/day or fluticasone = 200 mcg/day (or fluticasone 250mcg/day if subject is taking a 125mcg MDI rather than the 100mcg Diskus), for at least 3 months prior to Visit 1 and at a stable dose for at least 4 weeks prior to Visit 1.
• Able to use the Mini-Wright peak flow meter and subject or parent/guardian had to be able to record the subject's maximum PEF correctly.
• Able to perform FEV1 correctly.
• Subject's guardian/parent able to complete an eDRC on behalf of the subject. The eDRC should be completed by the guardian/parent.
• Able to use a DISKUS™ correctly.
• At least one parent(s)/guardian(s) has to give written informed consent to participate in the study.
• At the end of the run-in period (Visit 2), subjects must still meet the criteria for entry into the run-in period and also have:
• not achieved the criteria for the 'Well-controlled' asthma during two or more of the 4 weeks prior to Visit 2.

You may not qualify if:

• Female subjects who have reached menarche.
• Received any investigational study medication in the 4 weeks prior to Visit 1.
• Experienced a respiratory tract infection in the 4 weeks prior to Visit 1.
• Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 12 weeks of Visit 1.
• Any use of oral/parenteral or depot corticosteroid within 12 weeks of Visit 1.
• Any use of long-acting inhaled beta2-agonists or oral beta2-agonists within 4 weeks of Visit 1.
• Any use of leukotriene antagonists or theophyllines within 4 weeks of Visit 1.
• Any known clinical or laboratory evidence of a serious uncontrolled disease (including serious psychological disorders) which is, in the opinion of the investigator, likely to interfere with the study.
• Subjects with a known or suspected hypersensitivity to inhaled corticosteroids, beta2-agonists, or any components of the formulations (e.g. lactose)
• A relative of any of the site staff, including the investigator or study co-coordinator.
• Has previously been entered into this study.
• Subjects will be excluded from participating in the treatment period of the study if the following occurred during the run-in period:
• Pre-bronchodilator FEV1 \<60% (assuming that measurement was correctly performed).
• Any change in asthma medication (excluding use of prophylactic study specific salbutamol for prevention of asthma symptoms due to exercise).
• Respiratory tract infection or asthma exacerbation.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (65)

GSK Investigational Site

Bruges, 8000, Belgium

Location

GSK Investigational Site

Brussels, 1090, Belgium

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GSK Investigational Site

Edegem, 2650, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Aalborg, 9000, Denmark

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GSK Investigational Site

Odense, 5000 Odense C, Denmark

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GSK Investigational Site

Essey-lès-Nancy, 54270, France

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GSK Investigational Site

Grasse, 06130, France

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GSK Investigational Site

Laon, 02000, France

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GSK Investigational Site

Nîmes, 30900, France

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GSK Investigational Site

Oyonnax, 01100, France

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GSK Investigational Site

Paris, 75019, France

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GSK Investigational Site

Paris, 75730, France

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GSK Investigational Site

Rouen, 76000, France

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GSK Investigational Site

Rouen, 76031, France

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GSK Investigational Site

Saint-Michel, 16470, France

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GSK Investigational Site

Tours, 37000, France

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GSK Investigational Site

Vaux En Velin, 69120, France

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GSK Investigational Site

Villejuif, 94800, France

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GSK Investigational Site

Foggia, Apulia, 71100, Italy

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GSK Investigational Site

Napoli, Campania, 80138, Italy

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GSK Investigational Site

Palermo, Sicily, 90127, Italy

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GSK Investigational Site

Perugia, Umbria, 06122, Italy

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GSK Investigational Site

Daugavpils, LV5403, Latvia

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GSK Investigational Site

Riga, LV 1004, Latvia

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GSK Investigational Site

Riga, LV 1064, Latvia

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GSK Investigational Site

Kaunas, LT-50425, Lithuania

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GSK Investigational Site

Tauragė, LT-72214, Lithuania

Location

GSK Investigational Site

Vilnius, LT-10207, Lithuania

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GSK Investigational Site

Almere Stad, 1315 RA, Netherlands

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GSK Investigational Site

Beek en Donk, 5741 CG, Netherlands

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GSK Investigational Site

Deurne, 5751 XJ, Netherlands

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GSK Investigational Site

Emmen, 7824 AA, Netherlands

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GSK Investigational Site

Ermelo, 3851 EX, Netherlands

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GSK Investigational Site

Nieuwegein, 3435 CM, Netherlands

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GSK Investigational Site

Spijkenisse, 3207 NB, Netherlands

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GSK Investigational Site

The Hague, 2517 EW, Netherlands

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GSK Investigational Site

Tiel, 4002 WP, Netherlands

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GSK Investigational Site

Woerden, 3447 GN, Netherlands

Location

GSK Investigational Site

Drammen, N-3018, Norway

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GSK Investigational Site

Kongsvinger, N-2226, Norway

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GSK Investigational Site

Oslo, N-0855, Norway

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GSK Investigational Site

Bialystok, 15-274, Poland

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GSK Investigational Site

Krakow, 31-159, Poland

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GSK Investigational Site

Lodz, 93-513, Poland

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GSK Investigational Site

Lublin, 20-093, Poland

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GSK Investigational Site

Krasnoyarsk, 660022, Russia

Location

GSK Investigational Site

Moscow, 115446, Russia

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GSK Investigational Site

Moscow, 119435, Russia

Location

GSK Investigational Site

Moscow, 119991, Russia

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GSK Investigational Site

Novokuznetsk, 654063, Russia

Location

GSK Investigational Site

Novosibirsk, 630099, Russia

Location

GSK Investigational Site

St'Petersburg, 191144, Russia

Location

GSK Investigational Site

Syktyvkar, 167011, Russia

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GSK Investigational Site

Tomsk, 634 050, Russia

Location

GSK Investigational Site

Almería, 04009, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Madrid, 28006, Spain

Location

GSK Investigational Site

Madrid, 28009, Spain

Location

GSK Investigational Site

San Sebastián, 20014, Spain

Location

GSK Investigational Site

Seville, 41071, Spain

Location

GSK Investigational Site

Sollentuna, SE-191 24, Sweden

Location

GSK Investigational Site

Stockholm, SE-141 86, Sweden

Location

GSK Investigational Site

Stockholm, SE-171 76, Sweden

Location

Related Links

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

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 19, 2006
• Study Start: November 18, 2005
• Primary Completion: October 26, 2006
• Study Completion: October 26, 2006
• Last Updated: May 29, 2018
• Results First Posted: April 24, 2017

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (13); IT (4); DK (2); LA (3); NL (10); PL (4); RU (9); BE (5); LI (3); NO (3); SE (3); ES (6)