Anti-Inflammatory Reliever South Africa

NCT06429475 | Recruiting Phase 3 DMC

• 1 other identifier: BREC/00005663/2023
• Study Type: interventional
• Target: 1,038
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 3 single-centre open label randomised controlled trial with two equal sized groups to assess the efficacy of budesonide/formoterol 80/4.5 (6-11 years) and 160/4.5 (12-18 years) compared to the standard of care in reducing asthma exacerbations over 52 weeks. Children and adolescents with a diagnosis of asthma or newly diagnosed with asthma will be screened for eligibility for enrolment. Those who had an asthma exacerbation in the previous year will be randomised 1:1, to either receive budesonide/formoterol inhaler for both symptom relief and for chronic anti- inflammatory maintenance therapy or the standard of care which is separate inhalers for symptom relief (short acting bronchodilator salbutamol) and chronic maintenance therapy with inhaled corticosteroids (beclomethasone or budesonide) and/or long-acting beta agonists or montelukast as determined by treating physicians. All asthma exacerbations and clinic/hospital admissions will be recorded for the duration of the 52-week follow-up. Participants will be followed up at 13, 26, 39 and 52 weeks. The 13- and 39-week visit will be telephonic visits to capture the primary end-point i.e. asthma exacerbations. Adverse events and medication changes data will also be collected. An independent Data and Safety Monitoring Board (DSMB) will be convened for this study with expertise in asthma and asthma clinical trials. The purpose of the DSMB will be to monitor the study for safety and operational futility with pre-defined stopping criteria. In addition, a Trial Steering Committee (TSC) will also provide overall supervision of the trial and ensure the trial is delivered in accordance with ICH-GCP. The TSC has been established with an independent Chair and include additional independent members including an observer early career researcher. Representatives of the Trial Funder (NIHR) and Sponsor (AHRI) will be invited to all TSC meetings.

Conditions

Asthma

Keywords

asthma; budesonide/formoterol; beclomethasone; budesonide; children; adolescents

Outcome Measures

Primary Outcomes (1)

• Number of exacerbations in 52 weeks ( End of study)

  Questionnaire- based-tool to capture number of exacerbations will be administered biweekly via a short message system, 6 monthly telephonic consultations and alternative 6 monthly clinic visits. Unscheduled visits will be captured using the bi-weekly questionnaires.

  52 weeks

Secondary Outcomes (1)

• Cost effectiveness

  52 weeks

Study Arms (2)

budesonide/formoterol group

EXPERIMENTAL

Budesonide-formoterol fumarate dihydrate at two dose strengths 80/4.5 and 160/4.5 administered via a pressurized metered dose inhaler (pMDI) or dry powder inhaler (DPI), respectively. The dosing will be dependent on asthma symptom severity ranging from 1 dose as needed and titrated up or down depending on asthma control.

Drug: Budesonide/formoterol

comparator: standard of care group

ACTIVE COMPARATOR

Standard of care

Drug: standard of care

Interventions

Budesonide/formoterol DRUG

The Investigational Medicinal Product (IMP) consists of a combination of Budesonide (corticosteroid) and Formoterol Furamate (fast-acting β2 agonist) dihydrate. The IMP is currently available and registered in dry powder form turbuhaler (Symbicort) and a pressurised metered dose inhaler (Vannair). The recommended doses are pMDI/DPI 80/4.5 1-2 puffs twice daily OR 1 puff as needed (a maximum daily dose of 8 puffs) for children 6-11 years of age and 160/4.5 1-2 inhalations twice daily or 1 puff as needed (a maximum daily dose of 12 puffs) for adolescents 12-18 years.

Also known as: No other intervention names

budesonide/formoterol group

standard of care DRUG

Any therapy that is prescribed as per asthma guidelines i.e. beclomethasone, budesonide and salbutamol, montelukast etc

Also known as: beclomethasone or budesonide & salbutamol or mentelukast

comparator: standard of care group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Known asthmatic on treatment.
• Newly diagnosed asthma based on investigator review and/or medical report.
• All patients will have their asthma diagnosis confirmed (both new or known asthmatic patients) by either spirometry with reversibility or excessive diurnal variability by PEFR twice daily over 2 weeks.
• Ability to perform Peak Expiratory Flow rate and/or bronchodilator reversibility testing.
• Only participants with mild, or moderate asthma , based on medical history
• At least one exacerbation of asthma in the past year as defined by an event requiring treatment with systemic corticosteroids for ≥3 days and/or a hospitalisation/emergency room visit for asthma requiring treatment with systemic corticosteroids.
• Written consent from the participant or parent/guardian and assent from study participants where applicable.
• Participant and/or parent/guardian agrees to comply with the study procedures, including the completion of the visits and be available for contact for telephonically for the non-contact visits

You may not qualify if:

• Tuberculosis (TB): active TB disease and contact with people with active TB disease in the last 6 months.
• Chronic sputum expectoration, chest pain, shortness of breath, dizziness, or light-headedness in the last 2 months.
• Cardiac arrythmia.
• Chronic conditions: thyrotoxicosis, phaeochromocytoma, cardiovascular disease, severe hypertension.
• Uncontrolled diabetes mellitus
• Patients with Peak Expiratory Flow Rate \< 50% of predicted , as these would be classified as severe asthmatics.
• Patients with any history of life-threatening asthma, defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
• Any use of biological therapy or immunomodulatory therapy such as methotrexate or regular oral prednisolone for the asthma management (STEP 5 GINA therapy).
• Any surgical or medical condition that would significantly alter the absorption, distribution, metabolism or excretion of the IMP which may jeopardise the safety of the participants. The investigator should make this determination in consideration of the volunteer's medical history.
• Any physical, mental or social condition, laboratory abnormality of history of illness that in the investigator's judgement might jeopardise the safety of the participant in the context of the study or might interfere with study procedures or the ability of the participant to adhere to and complete the study. The investigator should make this determination consideration of the volunteer's medical history.
• Inability to present for follow-up or leaving the study area within 12 months of enrolment.

Sponsors & Collaborators

• University of KwaZulu: lead

Study Sites (2)

Africa Research Health Institute Clinical Trial Unit

Mtubatuba, KwaZulu-Natal, 3935, South Africa

RECRUITING

Africa Research Health Institute Clinical Trial Unit

Mtubatuba, KwaZulu-Natal, 3965, South Africa

RECRUITING

Related Publications (1)

• Hlophe ST, Ndimande NN, Ngobese N, Mkwanazi E, Bird K, Mbonigaba J, Otwombe K, Lebina L, Mortimer K, Masekela R. Anti-inflammatory reliever therapy for asthma using inhaled budesonide/formoterol as-needed with or without maintenance in South African children (AIR-SA 001): a description of a randomised clinical trial protocol. BMJ Open Respir Res. 2025 Nov 17;12(1):e003378. doi: 10.1136/bmjresp-2025-003378.

  PMID: 41253413 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Standard of Care; Beclomethasone; Budesonide; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Pregnadienetriols; Pregnadienes; Steroids, Chlorinated; Phenethylamines; Ethylamines

Study Officials

• Limakatso Lebina, PhD

  Africa Health Research Institute

  STUDY DIRECTOR

Central Study Contacts

Refiloe Masekela, PhD

CONTACT

800-555-5555; masekelar@ukzn.ac.za

Nompumelelo Ngobese

CONTACT

800-555-5555; nompumelelo.ngobese@ahri.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Clinical Trial

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: May 28, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 15, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 years for the time of request
• Access Criteria: A log of names, signatures and initials of all staff authorised to enter data into a participant's clinic file and eCRF will be kept.

Locations

ZA (2)