Effect of Add-on Montelukast to Inhaled Corticosteroids on Airway Responsiveness (SINGDEN)

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Montelukast (Singulair); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00913328

SINGDEN-04-2002

Details and patient eligibility

About

Leukotriene receptor antagonists appear to posses additive anti-inflammatory effects to the effect of inhaled corticosteroids.

Hypothesis: Treatment with oral montelukast will lower the dose-response plateau to inhaled methacholine in patients with mild to moderate persistent asthma treated with a stable dose of inhaled corticosteroids.

Enrollment: 31 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Non-smoking adults with mild to moderate persistent asthma:

  • FEV1 > 70 % pred
  • PD20 methacholine < 3.9 mmol
  • treated for at least 3 months with a stable dose of inhaled corticosteroids

• Documented dose-response plateau to inhaled methacholine on two occasions

• Males and non-pregnant females

Exclusion criteria

• Asthma medication other than inhaled corticosteroids and inhaled b2-agonists
• Viral respiratory tract infections within the 3 weeks prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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31 participants in 2 patient groups, including a placebo group

Montelukast

Active Comparator group

Description:

Oral montelukast 10 mg once daily for 12 weeks

Treatment:

Drug: Montelukast (Singulair)

Placebo

Placebo Comparator group

Description:

Oral placebo once daily for 12 weeks

Treatment:

Drug: Placebo