Does a low Exhaled Nitric Oxide level exclude a clinical benefit from inhaled corticosteroids in suspected asthma; a randomised, placebo controlled trial.

Does a low exhaled Nitric Oxide level exclude a clinical benefit from inhaled corticosteroids in suspected asthma; a double-blind, randomised, placebo controlled trial. - Low exhaled NO and inhaled corticosteroids in suspected asthma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000338-23-GB

Enrollment

165

Registered

2016-02-03

Start date

2016-03-21

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

suspected asthma people with asthma like symptoms

Interventions

Trade Name: Pulmicort Product Name: Budesonide Product Code: NDC 0186-0915-42 Pharmaceutical Form: Inhalation powder INN or Proposed INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 18 years or over. Asthma suspected by GP / Practice Nurse Low Exhaled Nitric Oxide reading 70% predicted Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Patients requiring oral steroid treatment on visit to GP/Practice nurse Use of oral prednisolone or antibiotics within last 4 weeks Already using an inhaled corticosteroid Any other clinically significant co-morbidity inc., bronchiectasis, COPD Expectant or breast-feeding mothers

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The primary endpoint will be the difference in asthma control (ACQ-7) between the inhaled steroid and placebo group adjusted for differences in baseline. ; Timepoint(s) of evaluation of this end point: The study will complete after 3 months and results should be available within 6 months of study completion. ; Main Objective: The purpose of the study is to determine if a low exhaled nitric oxide level (<27ppb) is a good predictor of a negative clinical benefit from inhaled corticosteroids in patients with suspected asthma? The primary objective is to determine if asthma symptoms, using the 7 point ACQ (Asthma Control Questionnaire), differ between the low dose inhaled steroid and placebo groups. ;Secondary Objective: To provide information on non-specific respiratory symptoms using the Medical Research Council dyspnoea scale (MRC) and Leicester Cough Questionnaire LCQ	—

Measure

Time frame

Primary end point(s): The primary endpoint will be the difference in asthma control (ACQ-7) between the inhaled steroid and placebo group adjusted for differences in baseline. ; Timepoint(s) of evaluation of this end point: The study will complete after 3 months and results should be available within 6 months of study completion. ; Main Objective: The purpose of the study is to determine if a low exhaled nitric oxide level (<27ppb) is a good predictor of a negative clinical benefit from inhaled corticosteroids in patients with suspected asthma? The primary objective is to determine if asthma symptoms, using the 7 point ACQ (Asthma Control Questionnaire), differ between the low dose inhaled steroid and placebo groups. ;Secondary Objective: To provide information on non-specific respiratory symptoms using the Medical Research Council dyspnoea scale (MRC) and Leicester Cough Questionnaire LCQ

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoint: Difference in FEV1, breathlessness score (MRC) and cough symptoms (LCQ) between inhaled steroid and placebo groups adjusted for differences in baseline;Timepoint(s) of evaluation of this end point: The study will complete after 3 months and results should be available within 6 months of study completion.	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026