TABLE 1.
Characteristics of the included studies
|
First author [reference], publication year;
study funding |
Study design; follow-up period |
Sample size;
age range (mean) |
Diagnosis |
Intervention
or control group |
PROM administered | PROM as primary, secondary or tertiary outcome | End-point measure | Adverse events reported |
| LTRA versus ICS | ||||||||
| Bukstein [36], 2003; Merck & Co, Clinical Development, US Human Health |
Observational; 12 months |
Total n=104 6–15 years (9.6 years) |
Mild persistent asthma | I: montelukast (10 mg) C: fluticasone (176 μg) |
ATAQ | Secondary | Mean±sd | No |
| Stelmach [37], 2005#; Medical University of Lodz, Poland |
RCT; 6 months |
Total n=51 6–18 years (11.8 years) |
Newly diagnosed atopic asthma | I: montelukast (5 or 10 mg) C: budesonide (400 or 800 μg) |
Asthma symptom score (0–9) (daytime/night-time/β2-agonist use) | Secondary | Mean±sem | No |
| García-García [38], 2005; Merck & Co |
RCT; 12 months |
Total n=541 6–14 years (median 9 years) |
Mild persistent asthma | I: montelukast (5 mg) C: fluticasone (200 μg) |
PATAQ overall | Tertiary | Mean change (95% CI) | Yes |
| Ostrom [39], 2005#; GlaxoSmithKline Inc |
RCT; 12 weeks |
Total n=342 6–12 years (9.35 years) |
Chronic asthma | I: montelukast (5 mg) C: fluticasone (100 μg) |
Daytime symptom score (0–5) Night-time symptom score (0–3) Satisfaction with treatment+ |
Not specified | Mean±sem Mean change±sem |
Yes |
| Szefler [40], 2007; AstraZeneca LP |
RCT; 52 weeks |
Total n=312 2–8 years (4.65 years) |
Mild persistent asthma | I: montelukast (5 mg) C: budesonide (500 μg) |
CHQ-PF50: general/ activities CHSA: physical/activities/emotional Asthma symptom score (am/pm) |
Secondary | Mean±sd Mean±sem Adjusted mean change±sem |
Yes |
| Olszowiec-Chlebna [41], 2010; Medical University of Lodz, Poland |
RCT; 6 months |
Total n=60 5–18 years (8.53 years) |
Newly diagnosed asthma | I: montelukast (5 or 10 mg) C: budesonide (400 and 800 μg) |
ATAQ | Not specified | Mean±sd | No |
| Parisi [42], 2022; University of Catania, Italy |
RCT; 12 weeks |
Total n=42 2–6 years (3.5 years) |
Recurrent wheezing | I: montelukast (4 or 5 mg) C: beclomethasone (200 μg) |
TRACK | Primary | Mean±sd | Yes |
| LTRA versus other treatment combinations | ||||||||
| Malmstrom [43], 1999¶; Merck Research Laboratories |
RCT; 12 weeks |
Total n=895 >15 years Paediatric n=45 15–18 years |
Chronic asthma |
I: montelukast (10 mg) C: beclomethasone (400 μg) C: placebo |
Daytime asthma symptoms Global evaluation question+ AQLQ+ |
Primary | Mean±sd Mean change±sd |
Yes |
| Williams [44], 2001¶; Merck Research Laboratories |
RCT; 16 weeks |
Total n=1055 15–85 years Paediatric n=245 6–14 years |
Chronic asthma | I: montelukast (5 or 10 mg) C: beclomethasone (300 μg) C: placebo |
PAQLQ: activity/symptom/emotional | Not specified | Mean Adjusted mean change (95% CI) |
No |
| Peters [45], 2007; GlaxoSmithKline, American Lung Association |
RCT; 16 weeks |
Total n=500 >15 years Paediatric n=245 6–14 years |
Mild persistent controlled asthma | I: montelukast (5 or 10 mg) C: fluticasone (200 μg) C: fluticasone (100 μg) + salmeterol (50 μg) |
Mini AQLQ ASUI+ ACQ+ |
Secondary | Adjusted mean±sd (95% CI) | No |
| Máspero [46], 2008; GlaxoSmithKline |
RCT; 12 weeks |
Total n=548 6–14 years (9.3 years) |
Persistent uncontrolled asthma | I: montelukast (5 mg) C: salmeterol/fluticasone (100/200 μg) |
PAQLQ Asthma symptom score (0–5)+ |
Secondary | Adjusted mean change±sem |
No |
| Bérubé [47], 2014; Merck Frosst Canada Ltd |
Observational; 12 weeks |
Total n=328 2–14 years (6.92 years) |
Uncontrolled asthma | I: montelukast (4 or 5 mg) C: montelukast (4 or 5 mg) ICS (different doses) |
ACQ | Primary and secondary | Mean±sd (95% CI) Mean change±sd |
No |
| LTRA versus placebo | ||||||||
| Knorr [48], 1998; Merck & Co Inc Becker [49], 2004; Merck & Co Inc |
RCT; 8 weeks |
Total n=336 6–14 years (median 11 years) |
Mild asthma | I: montelukast (5 mg) C: placebo |
PAQLQ: activity/symptom/emotional Daytime symptom score (0–5) Night-time symptom score (0–5) |
Primary | Mean±sd Mean change (95% CI) |
No |
| Knorr [50], 2001¶; Merck Research Laboratories |
RCT; 12 weeks |
Total n=689 2–5 years (3.6 years) |
Mild to severe persistent asthma | I: montelukast (4 mg) C: placebo |
Daytime-symptom score (0–5) Overnight asthma symptoms |
Secondary | Mean change (95% CI) | Yes |
| Stelmach [51], 2002; Medical University of Lodz, Poland |
RCT; 6 weeks |
Total n=32 6–18 years (13.5 years) |
Mild to moderate asthma | I: montelukast (5 or 10 mg) C: placebo |
Asthma symptom score (0–9) (daytime/night-time/β2-agonist use) | Secondary | Mean±sd (95% CI) |
No |
| Stelmach [52], 2002#; Medical University of Lodz, Poland |
RCT; 8 weeks |
Total n=49 9–15 years (11.9 years) |
Moderate atopic asthma | I: montelukast (5 or 10 mg) C: placebo |
Asthma symptom score (0–9) (daytime/night-time/β2-agonist use) PAQLQ+ |
Not specified | Mean±sd (95% CI) |
No |
| Philip [53], 2004¶; Merck Research Laboratories |
RCT; 2 weeks |
Total n=831 15–85 years Paediatric n=102 15–18 years |
Asthma and seasonal allergic rhinitis | I: montelukast (10 mg) C: placebo |
Daily rhinitis symptoms (0–3) Daytime symptom score (0–3) Night-time symptom score (0–3) RQLQ+ |
Primary | Mean change±sd | No |
| Chen [54], 2006; Chung Shan Medical University Hospital, Taiwan |
RCT; 12 weeks |
Total n=40 2–6 years (4.4 years) |
Rhinitis | I: montelukast (5 mg) C: placebo |
PRQLQ Symptom score |
Not specified | Mean±sd Mean change±sd |
No |
| Spahn [55], 2006;# Merck & Co Inc |
RCT; 8 weeks |
Total n=21 9–18 years (13.1 years) |
Mild to moderate asthma | I: montelukast (5 or 10 mg) C: placebo |
Daytime symptom score (0–3) Night-time symptom score (0–3) |
Not specified | Mean±sem | Yes |
| Stelmach [56], 2015; Medical University of Lodz, Poland. National Science Centre |
RCT; 30 weeks |
Total n=76 6–14 years (10.7 years) |
Allergic asthma | I: montelukast (5 mg) C: placebo |
ACT | Not specified | Mean±sd | No |
| Sahiner [57], 2021; Merck Sharp and Dohme Company |
RCT; 4 weeks |
Total n=46 6–18 years (11 years) |
Asthma | I: montelukast (10 mg) C: placebo |
ACT | Secondary | Mean±sd | No |
PROM: patient-reported outcome measure; LTRA: leukotriene receptor antagonist; ICS: inhaled corticosteroid; I: intervention group; C: control group; ATAQ: Asthma Therapy Assessment Questionnaire for children; RCT: randomised controlled trial; PATAQ: Pediatric Asthma Therapy Assessment Questionnaire; CHQ-PF50: Child Health Questionnaire Parent Form-50; CHSA: Children's Health Survey for Asthma; TRACK: Test for Respiratory and Asthma Control in Kids; AQLQ: Asthma Quality of Life Questionnaire; PAQLQ: Pediatric Asthma Quality of Life Questionnaire; ASUI: Asthma Symptom Utility Index; ACQ: Asthma Control Questionnaire; RQLQ: Rhinoconjunctivitis Quality of Life Questionnaire; PRQLQ: Pediatric Rhinoconjunctivitis Quality of Life Questionnaire; ACT: Asthma Control Test. #: citations identified from other reviews; ¶: data obtained after contacting sponsor; +: PROM information not available.