Olodaterol

STIOLTO RESPIMAT STIOLTO RESPIMAT contains both tiotropium and olodaterol. The properties described below for the individual components apply to STIOLTO RESPIMAT.

• STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD.ICD-10: J44.9

• Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1) ] . STIOLTO RESPIMAT is not indicated for the treatment of asthma.contraindicated

For oral inhalation only. Two inhalations of STIOLTO RESPIMAT once-daily at the same time of day. ( 2 ) 2.1 Recommended Dosage The recommended dosage of STIOLTO RESPIMAT is two inhalations once-daily at the same time of the day. Do not use STIOLTO RESPIMAT more than two inhalations every 24 hours. 2.2 Administration Information For oral inhalation only. Prior to first use, the STIOLTO RESPIMAT cartridge is inserted into the STIOLTO RESPIMAT inhaler and the unit is primed. When using the unit for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use [see Patient Counseling Information (17) ] . No dosage adjustment is required for geriatric, hepatically-impaired, or renally-impaired patients. However, patients with moderate to severe renal impairment given STIOLTO RESPIMAT should be monitored closely for anticholinergic effects [see Warnings and Precautions (5.10) , Use in Specific Populations (8.5 , 8.6 , 8.7) , and Clinical Pharmacology (12.3) ] .

LABA as monotherapy (without an inhaled corticosteroid) for asthma increases the risk of serious asthma-related events. ( 5.1 ) Do not initiate STIOLTO RESPIMAT in acutely deteriorating COPD patients. ( 5.2 ) Do not use for relief of acute symptoms. Concomitant short-acting beta 2 -agonists can be used as needed for acute relief. ( 5.2 ) Do not exceed the recommended dosage. Excessive use of STIOLTO RESPIMAT, or use in conjunction with other medications containing LABA can result in clinically significant cardiovascular effects and may be fatal. ( 5.3 ) Immediate hypersensitivity reactions: Discontinue STIOLTO RESPIMAT at once and consider alternatives if immediate hypersensitivity reactions, including angioedema, urticaria, rash, bronchospasm, or anaphylaxis, occur. ( 5.4 ) Life-threatening paradoxical bronchospasm can occur. Discontinue STIOLTO RESPIMAT immediately. ( 5.5 ) Use with caution in patients with cardiovascular or convulsive disorders, thyrotoxicosis, or sensitivity to sympathomimetic drugs. ( 5.6 , 5.7 ) Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to consult a physician immediately if this occurs. ( 5.8 ) Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to consult a physician immediately if this occurs. ( 5.9 ) Be alert to hypokalemia and hyperglycemia.

LABA, such as olodaterol, one of the active components in STIOLTO RESPIMAT, as monotherapy (without an inhaled corticosteroid) for asthma, increase the risk of asthma-related events. STIOLTO RESPIMAT is not indicated for the treatment of asthma [see Warning and Precautions (5.1) ]. The following adverse reactions are described, or described in greater detail, in other sections: Immediate hypersensitivity reactions [see Warnings and Precautions (5.4) ] Paradoxical bronchospasm [see Warnings and Precautions (5.5) ] Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.8) ] Worsening of urinary retention [see Warnings and Precautions (5.9) ] The most common adverse reactions (>3% incidence and more than an active control) were nasopharyngitis, cough, and back pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions observed in the clinical trials of a drug cannot be directly compared to the incidences in the clinical trials of another drug and may not reflect the incidences observed in practice. The clinical program for STIOLTO RESPIMAT included 7,151 subjects with COPD in two 52-week active-controlled trials, one 12-week placebo-controlled trial, three 6-week placebo-controlled cross-over trials, and four additional trials of shorter duration.

Patients with moderate to severe renal impairment should be monitored closely for potential anticholinergic side effects. ( 2 , 8.7 ) 8.1 Pregnancy Risk Summary There are no adequate and well-controlled clinical studies with STIOLTO RESPIMAT or its individual components, tiotropium bromide and olodaterol, in pregnant women to inform of drug-associated risk of adverse pregnancy-related outcomes. Animal reproduction studies were conducted with the individual components of STIOLTO RESPIMAT, tiotropium bromide and olodaterol. There are clinical considerations with the use of STIOLTO RESPIMAT in pregnant women (see Clinical Considerations ) . STIOLTO RESPIMAT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Based on animal reproduction studies, no structural abnormalities were observed when tiotropium was administered by inhalation to pregnant rats and rabbits during the period of organogenesis at doses 790 and 8 times, respectively, the maximum recommended human daily inhalation dose (MRHDID). Increased post-implantation loss was observed in rats and rabbits administered tiotropium at maternally toxic doses 430 times and 40 times the MRHDID, respectively (see Data ) .

Metabolism

STIOLTO RESPIMAT When STIOLTO RESPIMAT was administered by the inhalation route, the pharmacokinetic parameters for tiotropium and for olodaterol were similar to those observed when each active substance was administered separately. Tiotropium Tiotropium is administered as an inhalation spray.

STIOLTO RESPIMAT contains both tiotropium bromide and olodaterol; therefore, the risks associated with overdosage for the individual components described below apply to STIOLTO RESPIMAT. Tiotropium High doses of tiotropium may lead to anticholinergic signs and symptoms. However, there were no systemic anticholinergic adverse effects following a single inhaled dose of up to 282 mcg tiotropium in 6 healthy volunteers. In a study of 12 healthy volunteers, bilateral conjunctivitis and dry mouth were seen following repeated once-daily inhalation of 141 mcg of tiotropium. Dry mouth/throat and dry nasal mucosa occurred in a dose-dependent [10-40 mcg daily] manner, were observed following 14-day dosing of up to 40 mcg tiotropium bromide inhalation solution in healthy subjects.

• Jul 31, 2014NDANDA203108Boehringer Ingelheim
• May 21, 2015NDANDA206756Boehringer Ingelheim

1. 1Dyspnoea92918%
2. 2Cough4218.1%
3. 3Drug Ineffective3556.8%
4. 4Off Label Use3136.0%
5. 5Fatigue2434.7%
6. 6Headache2304.4%
7. 7Death2214.3%
8. 8Pneumonia2154.1%
9. 9Chronic Obstructive Pulmonary Disease2104.0%
10. 10Diarrhoea2084.0%
11. 11Dizziness1853.6%
12. 12Nausea1843.5%
13. 13Product Quality Issue1763.4%
14. 14Fall1372.6%
15. 15Asthenia1332.6%

The 10 most recently updated of 104 ClinicalTrials.gov registrations naming Olodaterol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD
  Suspended · Interventional · 100 enrolled · Medical University of Bialystok
  NCT07541378updated 2026-04-21
• Effects of Tiotropium/Olodaterol on Cardio-pulmonary Exercise Capacity in Patients With Hyperinflated Chronic Obstructive Pulmonary Disease [ACHIEVE]
  Completed · Interventional · 44 enrolled · Yonsei University
  NCT04994574updated 2026-04-07
• A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects
  Recruiting · Phase 1 · Interventional · 57 enrolled · Chia Tai Tianqing Pharmaceutical (Guangzhou) Co., Ltd.
  NCT07267130updated 2026-03-10
• ANTES B+ Clinical Trial
  Terminated · Phase 4 · Interventional · 48 enrolled · Fundacio Privada Mon Clinic Barcelona
  NCT06282861updated 2025-08-14
• Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD
  Active not recruiting · Interventional · 60 enrolled · Istanbul Medeniyet University
  NCT07058259updated 2025-07-10
• A Study on the Control of Chronic Obstructive Pulmonary Disease (COPD) in Patients Taking the Combination of Tiotropium and Olodaterol Using the Respimat® Inhaler
  Completed · Observational · 4,819 enrolled · Boehringer Ingelheim
  NCT03663569updated 2025-01-07
• Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
  Completed · Observational · 19,467 enrolled · Boehringer Ingelheim
  NCT05393245updated 2024-12-04
• Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
  Completed · Observational · 17,018 enrolled · Boehringer Ingelheim
  NCT05402020updated 2024-08-09
• Quality of Life in Chronic Obstructive Pulmonary Disease (COPD) Patients After Switching to Tiotropium Plus Olodaterol Fixed Dose Combination in Greece
  Completed · Observational · 1,396 enrolled · Boehringer Ingelheim
  NCT04672941updated 2024-06-25
• Spiolto® Respimat® (Tiotropium/Olodaterol) Versus Triple Combination Therapy in Everyday Clinical Treatment Practice for Chronic Obstructive Pulmonary Disease (EVELUT®)
  Completed · Observational · 469 enrolled · Boehringer Ingelheim
  NCT03954132updated 2024-04-24

Frequently asked questions

How does Olodaterol work?

STIOLTO RESPIMAT STIOLTO RESPIMAT contains both tiotropium and olodaterol. The properties described below for the individual components apply to STIOLTO RESPIMAT.

What is Olodaterol used for?

According to FDA labeling, Olodaterol carries indications including: STIOLTO RESPIMAT is a combination of tiotropium bromide, an anticholinergic and olodaterol, a long-acting beta 2 -adrenergic agonist (LABA) indicated for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). ( 1.1 ) Important limitations: STIOLTO RESPIMAT is NOT indicated to treat acute deterioration of COPD.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Olodaterol?

Olodaterol is classified as Selective beta-2-adrenoreceptor agonists, beta2-Adrenergic Agonist, Adrenergic beta2-Agonists, Bronchodilation.

What are the brand names for Olodaterol?

Olodaterol is marketed under brand names including Stiolto, Striverdi.

What are the contraindications for Olodaterol?

Olodaterol labeling lists contraindications including: Use of a LABA, including STIOLTO RESPIMAT, without an inhaled corticosteroid is contraindicated in patients with asthma [see Warnings and Precautions (5.1) ] . STIOLTO RESPIMAT is not indicated for the treatment of asthma.. Always consult the full prescribing information and a clinician.