Spiolto

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Spiolto Respimat is a fixed-dose combination inhaler containing tiotropium bromide (2.5 micrograms per puff) and olodaterol hydrochloride (2.5 micrograms per puff), delivering dual bronchodilation through a long-acting muscarinic antagonist (LAMA) and a long-acting beta-2 agonist (LABA).

It is licensed in the United Kingdom for the maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD).

Spiolto Respimat is delivered via the Respimat soft mist inhaler, a propellant-free device that generates a slow-moving aerosol cloud for improved lung deposition and ease of coordination.

COPD is a major public health concern in the United Kingdom, affecting approximately 1.2 million people with a confirmed diagnosis and an estimated further 2 million who remain undiagnosed.

The condition is characterised by progressive, largely irreversible airflow limitation associated with chronic inflammation of the airways and lung parenchyma.

Spiolto Respimat addresses the need for effective maintenance bronchodilation in patients whose symptoms are not adequately controlled with a single long-acting bronchodilator.

This page provides a comprehensive clinical overview of Spiolto Respimat, including its mechanism of action, clinical evidence, dosing, side effects, safety warnings, and how to obtain a prescription in the UK.

Important safety information about Spiolto Respimat

Before reading further, note the following key safety points about Spiolto Respimat.

• Spiolto Respimat is a maintenance inhaler for COPD. It must not be used to relieve acute breathlessness or as a rescue inhaler. Always carry a separate short-acting reliever inhaler (such as salbutamol) for sudden symptoms.
• Do not use Spiolto Respimat if you have asthma. This product is licensed for COPD only.
• If you experience sudden eye pain, blurred vision, or visual halos, stop the medication and seek urgent medical attention, as this may indicate acute angle-closure glaucoma.
• Do not exceed two puffs once daily. Using more than the recommended dose increases the risk of cardiovascular side effects.

What is COPD

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable condition characterised by persistent respiratory symptoms and airflow limitation caused by airway and alveolar abnormalities.

The primary cause is long-term exposure to harmful particles or gases, most commonly cigarette smoke, although occupational dusts, chemical fumes, and indoor air pollution from biomass fuels also contribute.

COPD encompasses chronic bronchitis (persistent productive cough) and emphysema (destruction of the alveolar walls), which frequently coexist.

The pathology of COPD involves chronic inflammation of the airways, lung parenchyma, and pulmonary vasculature, driven primarily by neutrophils, macrophages, and CD8+ T lymphocytes.

This leads to mucus hypersecretion, structural narrowing of the small airways (obstructive bronchiolitis), and destruction of the alveolar walls (emphysema), reducing the surface area for gas exchange.

Unlike asthma, the airflow limitation in COPD is largely irreversible, although bronchodilator therapy can produce meaningful improvements in symptoms, exercise capacity, and quality of life.

COPD in the United Kingdom

COPD is the second most common lung disease in the UK after asthma and is a leading cause of mortality, accounting for approximately 30,000 deaths per year.

It is responsible for over 140,000 hospital admissions annually and places a significant burden on NHS resources.

The National Institute for Health and Care Excellence (NICE) guideline NG115 and the GOLD (Global Initiative for Chronic Obstructive Lung Disease) strategy document provide the evidence-based framework for the pharmacological and non-pharmacological management of COPD in the UK.

How Spiolto Respimat works: dual bronchodilation

Spiolto Respimat combines two bronchodilators with complementary mechanisms of action to provide superior airway opening compared with either agent used alone.

Tiotropium: long-acting muscarinic antagonist (LAMA)

Tiotropium competitively and reversibly blocks muscarinic M3 receptors on airway smooth muscle cells. In COPD, increased cholinergic (vagal) tone is a major reversible component of airflow obstruction.

Acetylcholine released from parasympathetic nerve endings binds to M3 receptors, causing bronchoconstriction and mucus secretion. By blocking these receptors, tiotropium produces sustained bronchodilation lasting at least 24 hours.

Tiotropium dissociates very slowly from M3 receptors (half-life of dissociation approximately 35 hours), which underpins its once-daily dosing schedule and prolonged duration of action.

Olodaterol: long-acting beta-2 agonist (LABA)

Olodaterol is a selective beta-2 adrenoceptor agonist with a rapid onset of action (within 5 minutes) and a duration of at least 24 hours.

Stimulation of beta-2 receptors on airway smooth muscle activates the enzyme adenylyl cyclase, increasing intracellular cyclic adenosine monophosphate (cAMP).

Elevated cAMP activates protein kinase A, which phosphorylates proteins involved in smooth muscle contraction, leading to muscle relaxation and bronchodilation.

Olodaterol also increases mucociliary clearance, which may help improve airway patency in COPD.

Rationale for dual bronchodilation

The combination of a LAMA and a LABA targets two distinct pathways involved in airway smooth muscle tone.

The anticholinergic mechanism (LAMA) addresses the cholinergic bronchoconstrictor drive, while the beta-2 agonist mechanism (LABA) promotes active smooth muscle relaxation via adrenergic signalling.

The additive effect of these two mechanisms results in greater bronchodilation than can be achieved by increasing the dose of either component alone, while keeping the doses of each individual drug at levels associated with favourable safety profiles.

Clinical evidence for Spiolto Respimat

The efficacy and safety of tiotropium/olodaterol have been demonstrated in the TONADO, OTEMTO, and ENERGITO clinical trial programmes.

The TONADO studies (two replicate, 52-week, randomised, double-blind trials involving over 5,000 patients with moderate to very severe COPD) showed that tiotropium/olodaterol 5/5 micrograms once daily produced statistically significant and clinically meaningful improvements in trough FEV1, peak FEV1, and FEV1 area under the curve (AUC) from 0 to 3 hours compared with tiotropium alone, olodaterol alone, and placebo.

In the OTEMTO trials, tiotropium/olodaterol also demonstrated significant improvements in patient-reported outcomes, including the St George's Respiratory Questionnaire (SGRQ) total score and the Transition Dyspnoea Index (TDI).

These improvements exceeded the minimum clinically important difference thresholds, indicating meaningful benefits in terms of quality of life and breathlessness.

The ENERGITO study showed that tiotropium/olodaterol delivered via the Respimat inhaler provided superior bronchodilation compared with a fixed-dose combination of fluticasone/salmeterol delivered via a dry powder inhaler, supporting the role of dual bronchodilation as an alternative to ICS/LABA therapy in appropriate COPD patients.

Where Spiolto Respimat fits in COPD management

NICE guideline NG115 recommends a stepwise approach to COPD pharmacotherapy.

For patients with confirmed COPD and persistent breathlessness despite smoking cessation and pulmonary rehabilitation, initial pharmacological treatment is typically a short-acting bronchodilator used as needed.

If symptoms persist, a long-acting bronchodilator (either LAMA or LABA) is added as maintenance therapy.

If breathlessness or exacerbations continue despite monotherapy, NICE recommends stepping up to dual bronchodilation (LAMA plus LABA) in patients without features suggesting asthmatic or eosinophilic COPD.

Spiolto Respimat provides this dual bronchodilation in a single inhaler, simplifying treatment regimens and potentially improving adherence.

In patients with COPD who do not have features of asthma-COPD overlap, do not have raised blood eosinophils, and are not experiencing frequent exacerbations, LAMA/LABA therapy is preferred over ICS/LABA, as it avoids the potential risks of inhaled corticosteroids (such as pneumonia) while providing superior bronchodilation.

The Respimat soft mist inhaler

The Respimat device is a propellant-free inhaler that uses a spring-powered mechanism to force the drug solution through a precisely engineered nozzle (the uniblock), generating two fine jets of liquid that converge and create a slow-moving soft mist.

The mist has a velocity of approximately 0.8 metres per second and a duration of about 1.5 seconds, which is substantially slower and longer than conventional pressurised metered-dose inhalers (pMDIs).

This allows patients more time to coordinate inhalation with dose release and reduces the proportion of drug deposited in the oropharynx.

Lung deposition with the Respimat is approximately 50 to 60%, compared with 10 to 20% for typical pMDIs and 20 to 40% for dry powder inhalers.

The Respimat does not require high inspiratory flow rates, making it suitable for patients with severe airflow limitation who may struggle with dry powder inhalers.

Dosage and administration

The recommended dose is two puffs of Spiolto Respimat once daily, delivering a total daily dose of 5 micrograms of tiotropium and 5 micrograms of olodaterol.

The dose should be taken at the same time each day, ideally in the morning. The inhaler should not be used more than once daily.

No dose adjustment is required for elderly patients.

Patients with mild to moderate renal impairment do not require dose adjustment; use in severe renal impairment should be based on clinical judgement.

Spiolto Respimat is not recommended for patients under 18 years of age, as COPD is an adult disease.

Preparing and using the Respimat inhaler

When using a new inhaler or cartridge, the device must be primed before first use.

Insert the cartridge into the inhaler body by pressing it firmly until it clicks.

Turn the clear base in the direction of the arrows until it clicks (half a turn). Open the cap.

Point the inhaler towards the ground and press the dose release button. Repeat the turn-open-press sequence a total of three times until a visible mist is produced.

The inhaler is now ready for use.

For each subsequent dose, turn the base (half a turn until it clicks), open the cap, breathe out slowly, close your lips around the mouthpiece, breathe in slowly while pressing the dose release button, hold your breath for 10 seconds, and repeat for the second puff.

Side effects of Spiolto Respimat

Common side effects

The most commonly reported side effect is dry mouth, attributable to the anticholinergic action of tiotropium.

In clinical trials, dry mouth occurred in approximately 2 to 4% of patients, was generally mild in severity, and rarely led to treatment discontinuation.

Nasopharyngitis (common cold symptoms) has also been reported frequently in clinical trials, although distinguishing a drug-related effect from the high background rate of respiratory infections in COPD is difficult.

Uncommon side effects

Uncommon side effects include dizziness, insomnia, headache, cough, dysphonia (hoarseness), epistaxis (nosebleed), pharyngitis, constipation, oropharyngeal candidiasis, dysphagia (difficulty swallowing), nausea, tachycardia, palpitations, urinary tract infection, dysuria, and urinary retention.

Musculoskeletal effects such as back pain and arthralgia have been reported. Skin reactions including rash, pruritus, and urticaria occur uncommonly.

Rare and serious side effects

Rare side effects include acute angle-closure glaucoma, raised intraocular pressure, blurred vision, atrial fibrillation, supraventricular tachycardia, paradoxical bronchospasm, laryngeal irritation, sinusitis, intestinal obstruction including paralytic ileus, and angioedema.

Anaphylactic reactions are very rare. Hypokalaemia may occur with high doses of beta-2 agonists, particularly when combined with other medicines that lower potassium levels.

When to seek urgent medical advice

Contact your GP, pharmacist, or NHS 111 if you develop a persistent dry mouth, constipation, difficulty passing urine, or any new symptoms you think might be related to Spiolto Respimat.

Seek emergency medical help (call 999 or attend A&E) if you experience severe chest pain, rapid or irregular heartbeat, sudden worsening of breathlessness not relieved by your reliever inhaler, sudden eye pain or visual disturbance, or signs of a severe allergic reaction such as swelling of the face, lips, tongue, or throat.

Report any suspected adverse reactions via the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk .

Warnings and precautions

Not for acute use

Spiolto Respimat provides maintenance bronchodilation and should not be used for the acute relief of breathlessness or bronchospasm.

All patients should have a short-acting bronchodilator reliever available at all times.

If you need to use your reliever inhaler more frequently than usual or your symptoms are worsening despite maintenance treatment, this may indicate a COPD exacerbation requiring medical assessment and possible antibiotic or oral corticosteroid treatment.

Cardiovascular considerations

Beta-2 agonists can cause clinically significant cardiovascular effects, including increases in heart rate, blood pressure, and ECG changes (ST depression, T-wave flattening, QTc prolongation).

Patients with ischaemic heart disease, severe cardiac arrhythmias, cardiac failure, hypertrophic obstructive cardiomyopathy, or prolonged QTc interval should be monitored carefully.

Tiotropium has been studied extensively for cardiovascular safety; pooled data from the TIOSPIR and UPLIFT trials did not show an increased risk of major cardiovascular events with tiotropium Respimat compared with placebo or tiotropium HandiHaler.

Anticholinergic precautions

Due to the anticholinergic properties of tiotropium, Spiolto Respimat should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.

Patients should be advised to stop the medication and seek medical advice immediately if they develop eye symptoms or difficulty urinating.

Metabolic effects

Beta-2 agonists may cause hypokalaemia, hyperglycaemia, and metabolic acidosis at high doses. Serum potassium should be monitored in patients concurrently taking diuretics, corticosteroids, or xanthine derivatives. Patients with diabetes may need more frequent blood glucose monitoring when starting Spiolto Respimat.

How to get a Spiolto Respimat prescription in the UK

Spiolto Respimat is a prescription-only medicine (POM) in the UK.

It is typically prescribed by a GP, respiratory nurse specialist, or hospital respiratory physician following a confirmed diagnosis of COPD based on spirometry (post-bronchodilator FEV1/FVC ratio below 0.7).

It may also be prescribed by an authorised online prescriber registered with the General Pharmaceutical Council (GPhC) following a clinical assessment and review of spirometry results.

Spiolto Respimat is available on NHS prescription. The standard NHS prescription charge in England is 9.90 pounds per item. Prescriptions are free in Scotland, Wales, and Northern Ireland.

Many patients with COPD qualify for a medical exemption certificate or benefit from an NHS prescription prepayment certificate (PPC), which can reduce costs for those requiring multiple prescriptions.

Living with COPD: beyond inhalers

Pharmacological treatment with bronchodilators such as Spiolto Respimat is one component of comprehensive COPD management.

Equally important are smoking cessation (the single most effective intervention for slowing disease progression), pulmonary rehabilitation (a structured exercise and education programme that improves breathlessness, exercise tolerance, and quality of life), annual influenza vaccination, one-off pneumococcal vaccination, and self-management planning.

Patients should attend regular COPD reviews with their GP or respiratory nurse to monitor lung function, review inhaler technique, and optimise treatment according to current symptoms and exacerbation history.

Sources

• Spiolto Respimat, Summary of Product Characteristics (EMC)
• Tiotropium with olodaterol, British National Formulary (BNF)
• NICE NG115: Chronic obstructive pulmonary disease in over 16s: diagnosis and management
• GOLD: Global Initiative for Chronic Obstructive Lung Disease
• COPD, NHS
• MHRA Yellow Card Scheme