Onbrez
Onbrez Breezhaler contains indacaterol, an ultra-long-acting beta-2 agonist (LABA) inhaled once daily for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
Each capsule is loaded into the Breezhaler device and inhaled as a dry powder. Onbrez is not for asthma and is not a rescue inhaler.
It is a prescription-only medicine (POM) in the United Kingdom, manufactured by Novartis.
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Onbrez Breezhaler is a once-daily inhaled medicine containing indacaterol, an ultra-long-acting beta-2 agonist (LABA) used for the maintenance treatment of chronic obstructive pulmonary disease (COPD).
Each capsule delivers indacaterol as a dry powder via the Breezhaler inhalation device, providing rapid and sustained bronchodilation for a full 24 hours.
Onbrez is not for asthma and is not a rescue inhaler. It is a prescription-only medicine (POM) in the United Kingdom, manufactured by Novartis.
COPD is a progressive, largely irreversible respiratory condition characterised by persistent airflow limitation.
It encompasses chronic bronchitis (persistent cough with sputum production) and emphysema (destruction of the lung alveoli reducing gas exchange surface area).
In the United Kingdom, COPD affects approximately 1.2 million people and is a leading cause of hospital admissions, disability, and mortality.
Smoking is the primary cause of COPD, accounting for around 80 to 90 percent of cases, although occupational exposures, air pollution, and alpha-1 antitrypsin deficiency also contribute.
COPD cannot be cured, but effective treatment can relieve symptoms, reduce exacerbations, improve exercise capacity, and slow disease progression.
This page provides a comprehensive clinical guide to Onbrez Breezhaler, including how it works, dosage instructions, side effects, safety warnings, and how to obtain it in the United Kingdom.
Important safety information about Onbrez Breezhaler
Before reading further, please note these essential safety points.
- Onbrez is for COPD maintenance treatment only. It is not for asthma, acute bronchospasm, or rescue use.
- Always keep a separate short-acting reliever inhaler (such as salbutamol) available for emergencies.
- Do not use Onbrez with another LABA due to the risk of overdose.
- Report worsening symptoms, increased reliever use, or acute breathlessness to your prescriber or call 999 in an emergency.
- Onbrez capsules are for inhalation via the Breezhaler device only. Do not swallow them.
Understanding COPD
COPD is a chronic inflammatory lung disease that causes obstructed airflow from the lungs.
The two main components are chronic bronchitis, in which the bronchial tubes become inflamed and narrowed with excess mucus production, and emphysema, in which the air sacs (alveoli) at the end of the smallest airways are damaged and destroyed.
Most people with COPD have a combination of both conditions to varying degrees. The primary symptoms are persistent breathlessness, a chronic productive cough, wheezing, and chest tightness.
Symptoms are progressive, meaning they tend to worsen over time, particularly if the person continues to smoke.
Diagnosis is confirmed by spirometry, a breathing test that measures how much air you can breathe out in one second (FEV1) and the total amount of air you can forcibly exhale (FVC).
A post-bronchodilator FEV1/FVC ratio below 0.7 indicates airflow obstruction consistent with COPD.
The severity of COPD is graded according to the degree of airflow limitation: GOLD stage 1 (mild, FEV1 at or above 80 percent predicted), stage 2 (moderate, 50 to 79 percent), stage 3 (severe, 30 to 49 percent), and stage 4 (very severe, below 30 percent).
NICE guideline NG115 (Chronic obstructive pulmonary disease in over 16s: diagnosis and management) provides the framework for COPD diagnosis and treatment in the UK.
How Onbrez Breezhaler works
Indacaterol is a highly selective beta-2 adrenoceptor agonist. Beta-2 adrenoceptors are found predominantly on airway smooth muscle cells.
When indacaterol binds to these receptors, it triggers a cascade of intracellular signalling events: the receptor activates a stimulatory G protein, which in turn activates adenylyl cyclase, increasing levels of cyclic adenosine monophosphate (cAMP).
Raised cAMP activates protein kinase A, which phosphorylates multiple target proteins, ultimately causing relaxation of the airway smooth muscle.
This bronchodilation opens the narrowed airways, reduces air trapping, and improves expiratory flow.
What distinguishes indacaterol from earlier LABAs such as salmeterol and formoterol is its combination of rapid onset (within 5 minutes, comparable to formoterol) and ultra-long duration of action (approximately 24 hours, longer than both salmeterol and formoterol at standard doses).
This pharmacological profile is attributed to the high intrinsic efficacy of indacaterol at the beta-2 receptor and its lipophilic properties, which allow it to remain in the lipid layer of the airway cell membrane and provide sustained receptor stimulation.
The once-daily dosing simplifies treatment regimens and may improve adherence compared with twice-daily alternatives.
Clinical evidence for Onbrez Breezhaler
The efficacy of indacaterol has been demonstrated in multiple large randomised controlled trials (RCTs) in patients with moderate to severe COPD.
The INHANCE trial compared indacaterol 150 and 300 micrograms with placebo and open-label tiotropium 18 micrograms over 26 weeks.
Indacaterol 150 micrograms produced statistically significant improvements in trough FEV1 (the FEV1 measured 24 hours after the last dose) compared with placebo, with a mean improvement of approximately 130 to 180 mL.
It also demonstrated non-inferiority to tiotropium for this endpoint.
Patients reported improvements in dyspnoea scores, health-related quality of life (measured by the St George's Respiratory Questionnaire), and rescue medication use.
The INLIGHT-2 trial compared indacaterol 150 micrograms with salmeterol 50 micrograms twice daily over 26 weeks.
Indacaterol showed superior trough FEV1 improvement compared with salmeterol, supporting the clinical advantage of once-daily ultra-long-acting bronchodilation.
The ILLUMINATE trial compared indacaterol/glycopyrronium (QVA149) with salmeterol/fluticasone, demonstrating that dual bronchodilation without an ICS provided superior FEV1 improvement in patients without frequent exacerbations.
NICE NG115 recommends a structured approach to inhaler therapy in COPD, starting with a short-acting bronchodilator as needed, then stepping up to a long-acting bronchodilator (LABA or LAMA) for patients with persistent breathlessness or exacerbations.
Dual bronchodilation (LABA plus LAMA) is recommended if monotherapy is insufficient.
Triple therapy (LABA plus LAMA plus ICS) is reserved for patients with features suggesting asthma-COPD overlap or frequent exacerbations despite dual therapy.
Using the Breezhaler device
The Breezhaler is a single-capsule, low-resistance dry powder inhaler.
Unlike metered-dose inhalers (MDIs), it does not require coordination between pressing a canister and breathing in, as the powder is drawn from the pierced capsule by the patient's inhalation effort.
The low internal resistance of the Breezhaler means that even patients with significantly reduced inspiratory flow rates (common in severe COPD) can generate sufficient airflow to empty the capsule effectively.
The device provides auditory (a whirring sound during inhalation) and visual (the capsule spinning in the chamber) feedback to confirm that the dose is being delivered.
To prepare a dose, open the protective cap of the Breezhaler, then open the mouthpiece.
Remove one capsule from the blister strip immediately before use and place it in the capsule chamber. Close the mouthpiece until a click is heard.
Hold the inhaler upright and press both side buttons firmly once to pierce the capsule, then release them.
Breathe out completely (away from the device), place the mouthpiece between your lips, and breathe in rapidly and deeply through your mouth.
Hold your breath for at least 5 to 10 seconds, then breathe out through your nose.
Open the mouthpiece to inspect the capsule; if powder remains, close the mouthpiece and repeat the inhalation. Discard the used capsule.
Do not store capsules in the Breezhaler device.
Onbrez Breezhaler compared with other COPD inhalers
Several long-acting bronchodilators are available for COPD maintenance treatment in the UK. Tiotropium (Spiriva) is a once-daily LAMA delivered via the HandiHaler or Respimat device.
Salmeterol (Serevent) is a twice-daily LABA. Formoterol (Oxis) is a twice-daily LABA with rapid onset. Glycopyrronium (Seebri Breezhaler) is a once-daily LAMA that uses the same Breezhaler device.
Combination products include umeclidinium/vilanterol (Anoro Ellipta), aclidinium/formoterol (Duaklir Genuair), and indacaterol/glycopyrronium (Ultibro Breezhaler).
The choice between these agents depends on patient preference, device suitability, inspiratory flow rate, the need for once-daily versus twice-daily dosing, and whether the patient requires dual bronchodilation.
The Breezhaler device may be preferred by patients who value the confirmation feedback (whirring sound, spinning capsule) that reassures them the dose has been taken.
Patients already using a Breezhaler-delivered LAMA (glycopyrronium) may find it convenient to switch to the combination product (Ultibro Breezhaler) rather than using two separate devices.
Dosage and administration
The recommended starting dose is one 150 microgram capsule inhaled once daily via the Breezhaler at the same time each day.
If symptom control is inadequate, the dose may be increased to 300 micrograms once daily on the prescriber's recommendation. Do not exceed 300 micrograms in 24 hours.
If you miss a dose, take it as soon as you remember, then return to the usual schedule the following day. Do not double the dose.
Capsules should be removed from the blister strip only immediately before use. Store the capsules in the original packaging to protect from moisture and heat.
Do not use capsules that appear damaged, damp, or discoloured. Replace the Breezhaler device with each new prescription (each pack contains a replacement device).
Side effects of Onbrez Breezhaler
Common side effects
The most frequently reported side effects include upper respiratory tract infections (nasopharyngitis, sinusitis), cough immediately after inhalation, headache, and muscle spasms or cramps.
The post-inhalation cough is a well-recognised characteristic of indacaterol; it is brief, usually lasting only a few seconds, and does not indicate bronchospasm or worsening COPD.
Studies show it does not affect drug deposition in the lungs or reduce efficacy.
Uncommon side effects
Palpitations, tachycardia, dizziness, tremor, dry mouth, oropharyngeal pain (sore throat), musculoskeletal pain, peripheral oedema, and skin rash have been reported.
Paradoxical bronchospasm, where the airways narrow rather than open after inhalation, is rare. If it occurs, stop Onbrez, use your reliever inhaler immediately, and contact your prescriber.
Metabolic and cardiovascular effects
Beta-2 agonists can lower serum potassium levels (hypokalaemia) and temporarily raise blood glucose. These effects are dose-dependent and are usually clinically insignificant at the recommended inhaled dose.
However, patients taking corticosteroids or non-potassium-sparing diuretics concurrently should be monitored, as additive hypokalaemia may increase the risk of cardiac arrhythmias.
Heart rate and blood pressure may increase slightly. Clinical trials found no significant increase in major cardiovascular events with indacaterol.
When to seek medical advice
Seek urgent medical attention if you experience sudden worsening of breathlessness not relieved by your reliever inhaler, chest pain, swelling of the face, lips, tongue, or throat (angioedema), severe skin reactions, or persistent rapid or irregular heartbeat.
Call 999 in an emergency. Contact your GP or NHS 111 for persistent cough that worsens, increasing sputum production, fever, or signs of a chest infection.
Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk .
Warnings and precautions
Contraindications
Onbrez Breezhaler is contraindicated in patients with hypersensitivity to indacaterol, lactose, or any excipient. It must not be used in patients with asthma as the sole bronchodilator. It is not indicated for the treatment of acute bronchospasm.
Caution in specific conditions
Use Onbrez with caution in patients with ischaemic heart disease, heart failure, cardiac arrhythmias (especially tachyarrhythmias), congenital or acquired QT prolongation, hypertension, hyperthyroidism, diabetes mellitus, convulsive disorders, and phaeochromocytoma.
These conditions may be worsened by the sympathomimetic effects of beta-2 agonists.
Drug interactions
Do not use Onbrez with other LABAs. Caution is advised with non-potassium-sparing diuretics (furosemide, bendroflumethiazide), xanthine derivatives (theophylline), systemic corticosteroids, and other medicines known to cause hypokalaemia.
Strong CYP3A4 inhibitors (ketoconazole, itraconazole) and P-glycoprotein inhibitors (ritonavir, verapamil, erythromycin) may increase indacaterol levels.
Beta-blockers may antagonise the bronchodilator effect; cardioselective beta-blockers (bisoprolol, atenolol) may be used with caution if clinically indicated.
Smoking cessation and COPD management
The single most important intervention in COPD management is smoking cessation. Stopping smoking is the only intervention proven to slow the decline in lung function.
The NHS offers free support via the NHS Smokefree helpline (0300 123 1044), local stop-smoking services, and digital tools. Pharmacological aids include nicotine replacement therapy, varenicline, and bupropion.
Your GP or pharmacist can advise on the most appropriate option.
Even after starting Onbrez, stopping smoking remains essential to maximise the benefit of treatment and reduce the rate of disease progression.
Pulmonary rehabilitation, an evidence-based programme of supervised exercise and education, is recommended for all patients with COPD who have functional impairment.
Annual influenza vaccination and pneumococcal vaccination are also recommended. A comprehensive COPD management plan includes regular review, inhaler technique assessment, and an individualised self-management action plan for exacerbations.
How to get Onbrez Breezhaler in the UK
Onbrez Breezhaler is available on NHS prescription from your GP, respiratory specialist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).
The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland.
Prepayment certificates are available for those who need multiple prescription items regularly.
Sources
- Onbrez Breezhaler 150 microgram, Summary of Product Characteristics (EMC)
- Indacaterol, British National Formulary (BNF)
- NICE NG115: Chronic obstructive pulmonary disease in over 16s
- Chronic obstructive pulmonary disease (COPD), NHS
- Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- MHRA Yellow Card Scheme
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