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Accolate™ (zafirlukast) Clinical Trial report summaries
Accolate™ (zafirlukast) is an oral leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma. Available as a tablet, it blocks the effects of substances which cause constriction of the airways, build-up of mucus in the lungs and inflammation of the breathing passages.
Please consult the prescribing information for the country concerned for guidance on the approved use of Accolate™ (zafirlukast).
| Study Number | Completed Clinical Trial Report Summaries |
| A double-blind, placebo-controlled, parallel-group trial to assess the effects of ACCOLATE™ (20 mg bd) on airway hyperreactivity to inhaled methacholine. | |
| A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel-group, Multicenter, Safety and Efficacy Trial of Zafirlukast (ACCOLATE™) in the Treatment of Pediatric Patients with Mild-to-moderate Asthma; up to a 52-week Open-label Safety Extension (9188IL/0079). Report for the Open-label Extension only. | |
| A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Zafirlukast (ACCOLATE™) in Subjects Who Present to the Emergency Department with Asthma Exacerbations. | |
| 9188IL/0095 OLE | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Zafirlukast (ACCOLATE™) in Patients with Mild-to-moderate Asthma: 3 Weeks Efficacy and up to 104 Weeks Open-label Safety Extension. |
| 9188IL/0109 | A Double-blind, Placebo-controlled Trial to Determine the Effects of Zafirlukast (80 mg bd) and Beclomethasone Dipropionate (200mg bd), Given for 7 Days, on the Cellular Responses in the Airways to Inhaled Allergen Challenge (9188IL/0109). |
| A Study to Compare the Effects of ACCOLATE™ (80 mg bd), Loratadine (10 mg bd), Placebo, and a Combination of the 2 Treatments on the Response to Exercise Challenge in Asthmatic Patients. | |
| A Multicentre, Open-label, Long-term Safety Trial of ACCOLATE™ (20 mg bd) in Participants from Earlier ACCOLATE Clinical Trials. | |
| A Dose-ranging, Safety, and Efficacy Trial with Zafirlukast (ACCOLATE™) in the Treatment of Pediatric Subjects with Mild-to-moderate Asthma; up to a 52-week Open-label Safety Extension (9188IL/0139). Report for the Open-label Extension only. | |
| A randomised, double-blind, placebo-controlled, multicentre trial to demonstrate the efficacy, steroid-sparing effect and safety of oral zafirlukast (ACCOLATE™) 20 mg (morning and bedtime) in symptomatic asthma patients currently being treated with inhaled corticosteroid. | |
| A Multicenter, Double-blind Comparison of Zafirlukast (ACCOLATE™) with Placebo in Pediatric Subjects with Mild-to-moderate Asthma. | |
| 9188IL/0155 | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial to Determine the Efficacy of Oral Zafirlukast (ACCOLATE™) When Administered According to Current Labeling Instructions or Simplified Dosing Instructions in Subjects With Asthma Receiving Inhaledb2-agonist Alone or Inhaled b2-agonist in Combination With Inhaled Corticosteroids (ICS) (9188IL0155) |
| Randomized, Double-blind, Placebo-controlled, Crossover Trial of the Effect of ACCOLATE™ on Upper- and Lower-airway Symptoms and Markers of Inflammation Following Exposure to Cat Allergen. | |
| A randomized, double-blind, placebo-controlled, crossover trial to assess the effects of zafirlukast (ACCOLATE™) 20 mg twice daily when administered with food on exercise-induced bronchoconstriction induced in subjects with asthma. | |
| A Multicenter, Randomized, Double-blind, Dose Escalation Trial to Compare the Effect of Oral Doses of Zafirlukast (ACCOLATE™ ) in Subjects with Mild to Moderate Asthma. | |
| A Double-blind, Placebo-controlled Trial of Zafirlukast (ACCOLATE®) 20 mg BID Versus Placebo for the Treatment of Symptoms Associated with Rhinovirus Infection |
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Quick links - Products
- Accolate™ (zafirlukast)
- Arimidex™ (anastrozole)
- Atacand™ (candesartan cilexetil)
- Casodex™ (bicalutamide)
- Crestor™ (rosuvastatin)
- Diprivan™ (propofol)
- Entocort™ (budesonide)
- Exanta™ (ximelagatran)
- Faslodex™ (fulvestrant)
- Iressa™ (gefitinib)
- Losec™ (omeprazole)
- Merrem™ (meropenem)
- Naropin™ (ropivacaine)
- Nexium™(esomeprazole)
- Oxis™ (formoterol)
- Plendil™ (felodipine)
- Pulmicort™ (budesonide)
- Rhinocort™(budesonide)
- Seloken ZOK/Toprol-XL™ (metoprolol CR/XL)
- Seroquel™ (quetiapine)
- Symbicort™
- Tomudex™ (raltitrexed)
- Zoladex™ (goserelin acetate)
- Zomig™ (zolmitriptan)
- Products in Development
- Non-Drug Trials
