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. Author manuscript; available in PMC: 2020 Jun 10.
Published in final edited form as: Int Forum Allergy Rhinol. 2018 Feb;8(2):108–352. doi: 10.1002/alr.22073

TABLE IX.B.4.

Evidence for the use of leukotriene receptor antagonists as monotherapy in the treatment of allergic rhinitis (Level 1a and 1b studies only)

Study Year LOE Study design Study groups Clinical endpoint Conclusion
Devillier et al.1332 2014 1a SR of RCTs, with homogeneity
  1. LTRA;

  2. SLIT;

  3. Placebo

Symptoms SLIT superior clinical effect to LTRA. LTRA with clinical effect compared to placebo.
Goodman et al.1347 2008 1a SR of RCTs, with homogeneity
  1. Montelukast;

  2. Levocetirizine;

  3. Desloratadine;

  4. Fexofenadine

Symptoms, cost Montelukast with higher incremental cost-effectiveness ratio than levocetirizine and desloratadine.
Grainger & Drake-Lee1333 2006 1a SR of RCTs, with homogeneity
  1. Montelukast;

  2. Oral antihistamine;

  3. INCS;

  4. Placebo

Symptoms, QOL Montelukast improved symptoms and QOL compared to placebo, and was inferior to oral antihistamines and INCS.
Rodrigo & Yanez1334 2006 1a SR of RCTs, with homogeneity
  1. LTRA;

  2. Oral antihistamine;

  3. INCS;

  4. Placebo

Symptoms, QOL LTRA improved symptoms and QOL compared to placebo, was equally effective to oral antihistamine, and inferior to INCS.
Wilson et al.1300 2004 1a SR of RCTs, with homogeneity
  1. Montelukast;

  2. Oral antihistamine;

  3. INCS;

  4. Placebo

Symptoms, QOL Montelukast improved QOL compared to placebo, and was inferior to antihistamines and INCS.
Gonyeau & Partisan1335 2003 1a SR of RCTs, with homogeneity
  1. Montelukast;

  2. INCS;

  3. Placebo

Symptoms Montelukast was more effective than placebo in reducing symptoms, but was inferior to INCS.
Endo et al.1336 2012 1b RCT
  1. Pranlukast;

  2. Placebo

Symptoms Pranlukast prevented and reduced symptoms compared to placebo after artificial introduction of allergen.
Wakabayashi et al.1337 2012 1b RCT
  1. Pranlukast;

  2. Placebo

Symptoms Pranlukast reduced symptoms compared to placebo in children with artificial allergen exposure.
Day et al.1338 2008 1b RCT
  1. Montelukast;

  2. Levocetirizine;

  3. Placebo

Symptoms Both montelukast and levocetirizine improved symptoms following artificial allergen exposures. Levocetirizine was more effective than montelukast.
Jiang1348 2006 1b RCT
  1. Zafirlukast;

  2. Loratadine;

  3. Loratadine + pseudoephedrine

Symptoms, acoustic rhinometry, rhinomanometry All treatment groups had a significant reduction of pretreatment symptoms. Zafirlukast was superior at reduction of nasal congestion. There were no differences in acoustic rhinometry and rhinomanometry between the 3 treatment groups.
Mucha et al.1321 2006 1b RCT
  1. Montelukast;

  2. Pseudoephedrine

Symptoms, QOL, nasal peak inspiratory flow Montelukast and pseudoephedrine had equivalent improvement of symptoms (except nasal congestion for which pseudoephedrine was more effective), QOL, and nasal peak inspiratory flow.
Patel et al.1339 2005 1b RCT
  1. Montelukast;

  2. Placebo

Symptoms, QOL Montelukast was more effective than placebo in reducing symptoms and improving QOL in patients with perennial allergic rhinitis
Chervinsky et al.1340 2004 1b RCT
  1. Montelukast;

  2. Placebo

Symptoms, pollen count Montelukast was more effective than placebo in reducing symptoms. The effect size was related to the amount of pollen exposure.
Philip et al.1341 2004 1b RCT
  1. Montelukast;

  2. Placebo

Symptoms, rhinitis QOL, asthma QOL Montelukast improved symptoms, rhinitis QOL, and asthma QOL compared to placebo in patients with concurrent seasonal allergic rhinitis and asthma.
Ratner et al.1345 2003 1b RCT
  1. Montelukast;

  2. Fluticasone

Symptoms, QOL Fluticasone was more effective than montelukast in reducing symptoms and improving QOL.
van Adelsburg et al.1342 2003 1b RCT
  1. Montelukast;

  2. Loratadine;

  3. Placebo

Symptoms, QOL Montelukast was more effective than placebo in reducing symptoms and improving QOL. Montelukast not directly compared to loratadine.
van Adelsburg et al.1343 2003 1b RCT
  1. Montelukast;

  2. Loratadine;

  3. Placebo

Symptoms, QOL Montelukast was more effective than placebo in reducing symptoms and improving QOL. Montelukast not directly compared to loratadine.
Philip et al.1344 2002 1b RCT
  1. Montelukast;

  2. Loratadine;

  3. Placebo

Symptoms, QOL, peripheral eosinophil count Montelukast was more effective than placebo in reducing symptoms and peripheral eosinophil count, and improving QOL. Montelukast not directly compared to loratadine.
Pullerits et al.1346 1999 1b RCT
  1. Zafirlukast;

  2. Beclomethasone;

  3. Placebo

Symptoms, tissue eosinophilia Zafirlukast was not different from placebo in symptom or tissue eosinophilia reduction. Both were inferior to intranasal beclomethasone.

INCS = intranasal corticosteroids; LOE = level of evidence; LTRA = leukotriene receptor antagonist; QOL = quality of life; RCT = randomized controlled trial; SLIT = sublingual immunotherapy; SR = systematic review.

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