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

Completed · Phase 4

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT01462344

Run by

GlaxoSmithKline

People needed

6250

Starts

2011-11-17

Expected to finish

2015-11-03

Last updated by the study team

2018-08-06

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consent to participate in the study
• Age 4-11 years old
• 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
• Asthma diagnosis for at least 6 months
• Ability to answer questions regarding asthma control and use a metered dose inhaler and DISKUS
• 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.
• History of at least once occurrence of asthma exacerbation within the prior 12 months
• 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)

You may not qualify if…

• History of life-threatening asthma
• Unstable asthma
• Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
• 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.
• Respiratory infection
• Subjects with only exercise-induced asthma
• An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
• Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
• Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
• 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
• Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
• 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
• Severe hypersensitivity to cow's milk proteins
• 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
• Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
• Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
• 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.

Where it is running

• GSK Investigational Site — Birmingham, Alabama, United States
• GSK Investigational Site — Mobile, Alabama, United States
• GSK Investigational Site — Montgomery, Alabama, United States
• GSK Investigational Site — Scottsboro, Alabama, United States
• GSK Investigational Site — Toney, Alabama, United States
• GSK Investigational Site — Tuscaloosa, Alabama, United States
• GSK Investigational Site — Dothan, Alaska, United States
• GSK Investigational Site — Chandler, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Tucson, Arizona, United States
• GSK Investigational Site — Bentonville, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Alhambra, California, United States
• GSK Investigational Site — Bakersfield, California, United States
• GSK Investigational Site — Canoga Park, California, United States
• GSK Investigational Site — Dinuba, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Gold River, California, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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