A DOSE-RANGING STUDY OF VILANTEROL (VI) INHALATION POWDER IN CHILDREN AGED 5-11 YEARS WITH ASTHMA ON A BACKGROUND OF INHALED CORTICOSTEROID THERAPY

Not Applicable

• Registration Number: PER-125-11
• Lead Sponsor: GlaxoSmithKline,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-22
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 71

Inclusion Criteria

1. INFORMED CONSENT: WRITTEN INFORMED CONSENT FROM AT LEAST ONE PARENT/LEGAL GUARDIAN TO TAKE PART IN THE STUDY.
• IF APPLICABLE, SUBJECT MUST BE ABLE AND WILLING TO GIVE ASSENT TO TAKE PART IN THE STUDY ACCORDING TO THE LOCAL REQUIREMENT. THE STUDY INVESTIGATOR IS ACCOUNTABLE FOR DETERMINING A CHILD´S CAPACITY TO ASSENT TO PARTICIPATION IN A RESEARCH STUDY, TAKING INTO CONSIDERATION ANY STANDARDS SET BY THE RESPONSIBLE IEC/IRB.
• SUBJECT AND THEIR LEGAL GUARDIAN UNDERSTAND THAT THE STUDY REQUIRES THEM TO BE TREATED ON AN OUTPATIENT BASIS.
• SUBJECT AND THEIR LEGAL GUARDIAN UNDERSTAND THAT THEY MUST COMPLY WITH STUDY MEDICATION AND STUDY ASSESSMENTS INCLUDING RECORDING OF SYMPTOM SCORES AND RESCUE ALBUTEROL/SALBUTAMOL USE, ATTENDING SCHEDULED STUDY VISITS, AND BEING ACCESSIBLE BY A TELEPHONE CALL.
2. AGE 5-11 YEARS AT VISIT 1.
3. GENDER: MALE AND PRE-MENARCHIAL FEMALE. PRE-MENARCHIAL FEMALES ARE DEFINED AS ANY FEMALE WHO HAS YET TO BEGIN MENSES.
4. DIAGNOSIS OF ASTHMA: SUBJECTS MUST HAVE A HISTORY OF SYMPTOMS CONSISTENT WITH A DIAGNOSIS OF ASTHMA FOR AT LEAST 6 MONTHS PRIOR TO VISIT 1.

Exclusion Criteria

1. LIFE THREATENING ASTHMA: SUBJECTS WITH A HISTORY OF LIFE-THREATENING ASTHMA. DEFINED FOR THIS PROTOCOL AS AN ASTHMA EPISODE THAT REQUIRED INTUBATION, HYPERCAPNEA REQUIRING NON-INVASIVE VENTILATORY SUPPORT, RESPIRATORY ARREST, HYPOXIC SEIZURES OR ASTHMA-RELATED SYNCOPAL EPISODE(S).
2. ASTHMA EXACERBATION: SUBJECTS WITH A HISTORY OF ASTHMA EXACERBATION REQUIRING THE USE OF SYSTEMIC CORTICOSTEROIDS (TABLETS, SUSPENSION OR INJECTION) FOR AT LEAST 3 DAYS OR A DEPOT CORTICOSTEROID INJECTION OR REQUIRING HOSPITALIZATION FOR ASTHMA (WITHIN THE 6 MONTHS) PRIOR TO SCREENING.
3. CONCOMITANT MEDICATIONS: SUBJECTS CURRENTLY RECEIVING (OR HAVE RECEIVED WITHIN 4 WEEKS OF SCREENING) ASTHMA THERAPIES INCLUDING THEOPHYLLINES, LONG-ACTING INHALED BETA-AGONISTS, OR WHO HAVE CHANGED THEIR ASTHMA MEDICATION WITHIN 4 WEEKS OF SCREENING. CONCOMITANT MEDICATION: USE OF THE FOLLOWING MEDICATIONS IS PROHIBITED ACCORDING TO THE TIMEFRAMES BELOW
4. INFECTIONS: CULTURE-DOCUMENTED OR SUSPECTED BACTERIAL OR VIRAL INFECTION OF THE UPPER OR LOWER RESPIRATORY TRACT, SINUS OR MIDDLE EAR THAT IS NOT RESOLVED WITHIN 4 WEEKS OF VISIT 1 AND LED TO A CHANGE IN ASTHMA MANAGEMENT OR, IN THE OPINION OF INVESIGATOR, IS EXPECTED TO AFFECT THE SUBJECT´S ASTHMA STATUS OR THE SUBJECT´S ABILITY TO PARTICIPATE IN THE STUDY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified