An 8 week, non-selected, cohort, study to investigate whether the treatment of reflux induced cough alters associated bronchial hyperresponsiveness. - Bronchial Hyper-responsiveness and Reflux Cough

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004102-13-GB

Enrollment

Unknown

Registered

2006-09-18

Start date

2006-10-16

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

Bronchial hyper-responsiveness in relation to reflux associated chronic cough MedDRA version: 8.1 Level: HLT Classification code 10011233 Term: Coughing and associated symptoms

Interventions

Trade Name: Losec Pharmaceutical Form: Capsule, hard INN or Proposed INN: OMEPRAZOLE CAS Number: 73590586 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female subjects of atleast 18yrs of age Patients diagnosed with reflux associated chronic cough Positive Methacholine challenge test PC20=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: FEV1<60% predicted Subjects who are taking angiotensin converting enzyme inhibitors (ACE) Subjects with significant pathology on most recent X-Ray Patients already recieving or have taken in the last month a proton pump inhibitor combined with a H2 receptor antagonist (full acid suppression)

Design outcomes

Primary

Measure	Time frame
Main Objective: Studying newly diagnosed reflux associated chronic cough patients to identify those with associated hyperesponsive airways to methacholine challenge with porimary objective to determine the effects of 8 weeks anti-reflux therapy (full acid suppression) on bronchial hyper-responsiveness. ;Secondary Objective: Secondary objectives are to determine any change in cough and associated reflux symptoms through measurement of cough specific LPR score, spirometry cough challenge and cough severity scores.;Primary end point(s): Primary end point will be change in methacholine challenge PC20 from baseline to that post 8 weeks full acid suppression	—

Measure

Time frame

Main Objective: Studying newly diagnosed reflux associated chronic cough patients to identify those with associated hyperesponsive airways to methacholine challenge with porimary objective to determine the effects of 8 weeks anti-reflux therapy (full acid suppression) on bronchial hyper-responsiveness. ;Secondary Objective: Secondary objectives are to determine any change in cough and associated reflux symptoms through measurement of cough specific LPR score, spirometry cough challenge and cough severity scores.;Primary end point(s): Primary end point will be change in methacholine challenge PC20 from baseline to that post 8 weeks full acid suppression

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Countries

United Kingdom

Outcome results

None listed

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