Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomised trials

Kerstjens, Huib A. M.; Casale, Thomas B.; Bleecker, Eugene R.; Meltzer, Eli O.; Pizzichini, Emílio; Schmidt, Olaf; Engel, Michael; Bour, L.; Verkleij, C.B.; Moroni-Zentgraf, Petra; Bateman, Eric D.

doi:10.1016/s2213-2600(15)00031-4

Cited by 160 publications

(217 citation statements)

References 24 publications

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“…The safety of tiotropium as add-on treatment was examined in 3705 patients, 18,19,[21][22][23][24] either when added to a medium-dose ICS for 24 to 52 weeks 18,19,21,22 or to a high-dose ICS plus LABA for 48 weeks.…”

Section: Safety Of Tiotropium In Asthmamentioning

confidence: 99%

“…The safety profile of tiotropium was similar to that in previous studies. 21,24 Over 52 weeks, adverse events were generally mild and nonserious, and the overall tolerability profile of tiotropium was comparable to that of placebo.…”

mentioning

confidence: 95%

“…Again, the incidence of cardiac adverse events was less than 2%, with no difference in occurrence between the active or placebo treatment groups. [21][22][23][24] In the only study that examined tiotropium at a dose of 5 μg or 10 μg as add-on therapy to an ICS plus LABA in severe asthma, adverse events were slightly higher in subjects receiving tiotropium at a dose of 10 μg (50% vs 40% in subjects on tiotropium at a dose of 5 μg and 42% in subjects on placebo).…”

mentioning

confidence: 98%

“…However, the above studies 15,18,19 were relatively small. Recently, Kerstjens et al 21 published the results of the first large trials in adults with moderate symptomatic asthma (N = 2103). This consisted of 2 replicate randomized, double-blind, placebo-controlled, parallel-group studies, with an active comparator and 24-week follow-up.…”

mentioning

confidence: 99%

“…Tiotropium in mild-to-moderate asthma The role of tiotropium in mild-to-moderate asthma or in moderate asthma has been investigated in various randomized, double-blind, placebo-controlled clinical trials (RCTs) [15][16][17][18][19][20][21][22] with a duration that ranged from 4 to 52 weeks (TABLE 1), and reviewed in a recent meta-analysis. 13 The TALC trial 16 was the only published study to investigate the role of tiotropium in mild-to-moderate asthma, though an additional trial has been presented as an abstract.…”

mentioning

confidence: 99%

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Current role of anticholinergic drugs in the treatment of asthma: key messages for clinical practice

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Kerstjens

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2015

Polish Archives of Internal Medicine

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Section: Safety Of Tiotropium In Asthmamentioning

confidence: 99%

mentioning

confidence: 95%

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confidence: 98%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Current role of anticholinergic drugs in the treatment of asthma: key messages for clinical practice

Pizzichini

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Association of Inhaled Corticosteroids and Long-Acting Muscarinic Antagonists With Asthma Control in Patients With Uncontrolled, Persistent Asthma

Sobieraj

Baker

Nguyen

et al. 2018

JAMA

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Managing Asthma in Adolescents and Adults

Cloutier

Dixon

Krishnan

et al. 2020

JAMA

113

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IMPORTANCEAsthma is a major public health problem worldwide and is associated with excess morbidity, mortality, and economic costs associated with lost productivity. The National Asthma Education and Prevention Program has released the 2020 Asthma Guideline Update with updated evidence-based recommendations for treatment of patients with asthma.OBJECTIVE To report updated recommendations for 6 topics for clinical management of adolescents and adults with asthma: (1) intermittent inhaled corticosteroids (ICSs); (2) add-on long-acting muscarinic antagonists; (3) fractional exhaled nitric oxide; (4) indoor allergen mitigation; (5) immunotherapy; and (6) bronchial thermoplasty. EVIDENCE REVIEWThe National Heart, Lung, and Blood Advisory Council chose 6 topics to update the 2007 asthma guidelines based on results from a 2014 needs assessment. The Agency for Healthcare Research and Quality conducted systematic reviews of these 6 topics based on literature searches up to March-April 2017. Reviews were updated through October 2018 and used by an expert panel (n = 19) that included asthma content experts, primary care clinicians, dissemination and implementation experts, and health policy experts to develop 19 new recommendations using the GRADE method. The 17 recommendations for individuals aged 12 years or older are reported in this Special Communication.FINDINGS From 20 572 identified references, 475 were included in the 6 systematic reviews to form the evidence basis for these recommendations. Compared with the 2007 guideline, there was no recommended change in step 1 (intermittent asthma) therapy (as-needed short-acting β 2 -agonists [SABAs] for rescue therapy). In step 2 (mild persistent asthma), either daily low-dose ICS plus as-needed SABA therapy or as-needed concomitant ICS and SABA therapy are recommended. Formoterol in combination with an ICS in a single inhaler (single maintenance and reliever therapy) is recommended as the preferred therapy for moderate persistent asthma in step 3 (low-dose ICS-formoterol therapy) and step 4 (medium-dose ICS-formoterol therapy) for both daily and as-needed therapy. A short-term increase in the ICS dose alone for worsening of asthma symptoms is not recommended. Add-on long-acting muscarinic antagonists are recommended in individuals whose asthma is not controlled by ICS-formoterol therapy for step 5 (moderate-severe persistent asthma). Fractional exhaled nitric oxide testing is recommended to assist in diagnosis and monitoring of symptoms, but not alone to diagnose or monitor asthma. Allergen mitigation is recommended only in individuals with exposure and relevant sensitivity or symptoms. When used, allergen mitigation should be allergen specific and include multiple allergen-specific mitigation strategies. Subcutaneous immunotherapy is recommended as an adjunct to standard pharmacotherapy for individuals with symptoms and sensitization to specific allergens. Sublingual immunotherapy is not recommended specifically for asthma. Bronchial thermoplasty is not recommended as part...

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Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomised trials

Cited by 160 publications

References 24 publications

Current role of anticholinergic drugs in the treatment of asthma: key messages for clinical practice

Current role of anticholinergic drugs in the treatment of asthma: key messages for clinical practice

Association of Inhaled Corticosteroids and Long-Acting Muscarinic Antagonists With Asthma Control in Patients With Uncontrolled, Persistent Asthma

Managing Asthma in Adolescents and Adults

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