Cough
Conditions
Keywords
Hyper-responsiveness, reflux cough
Brief summary
The study aim is to determine the effect of 8 weeks of anti-reflux treatment (full acid suppression) on bronchial hyper-responsiveness and whether there is a symptomatic improvement.
Interventions
DRUGOmeprazole
20 mg BD tablet 8 weeks duration
DRUGRanitidine
300 mg od nocte tablet 8weeks duration
Sponsors
Hull University Teaching Hospitals NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Positive methacholine challenge test PC20 less than 4mg/ml (Can be previously documented in patients notes within last 4weeks) * Written informed consent * Patients with a history of chronic cough (at least 3 months duration), and associated symptoms of gastro-oesophageal reflux * Male and female subjects of at least 18 yrs of age * Subjects able to perform satisfactory FEV1 manoeuvres * Subjects able to understand the study and co-operate with the study procedures * Subjects who consent to their general practitioner (GP) being informed of their study participation
Exclusion criteria
* has had a heart attack in the last three months * suffers from angina, hypertension or ischaemic heart disease * has epilepsy for which he/she is taking medication * FEV1\< 60% predicted * FEV1\<1.6L * Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures * Suffering from any concomitant disease which may interfere with study procedures or evaluation. * A lower respiratory tract infection 4 weeks prior to entry on to study * Participation in another study (use of investigational product) within 30 days preceding entry on to study. * Alcohol or drug abuse * Use of opiates to treat cough 1 week prior to enrollment * Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors. * Subjects who have significant pathology on most recent chest X-Ray. * Inability to understand the procedures and the implications of a challenge test * Patients already taking or have taken in last 4 weeks PPI and H2 receptor antagonist (full acid suppression treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Methacholine Sensitivity | baseline and 8 weeks | Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20). To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire | 8 weeks |
Countries
United Kingdom
Participant flow
Recruitment details
Patients recruited at the cough clinic at castleHill Hospital
Pre-assignment details
Patients had to have a positive methacholine challenge, and reflux associated chronic cough
Participants by arm
| Arm | Count |
|---|---|
| Antacid Therapy Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | Antacid Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 49.8 years STANDARD_DEVIATION 8.53 |
| Region of Enrollment United Kingdom | 5 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Change in Methacholine Sensitivity
Concentration of methacholine (mg/ml) at which participants forced expired volume in 1 sec (FEV1) is reduced by 20% (the provocation concentration of methacholine causing a 20% fall in FEV1-PC20). To measure if there is a significant difference in PC20 recorded at baseline to that recorded following 8 weeks treatment with omeprazole and ranitidine
Time frame: baseline and 8 weeks
Population: All subjects recruited with efficacy data recorded after week T0 will be included in the ITT population for analysis. Assuming a within subject standard deviation(for change in PC20) of no more than 2.71 units, 30 subjects are sufficient to provide 80% power to detect a treatment difference of 1.8 units using a 5% two sided significance test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omeprazole and Ranitidine | Change in Methacholine Sensitivity | 0.598 mg/ml | Standard Deviation 0.479 |
Secondary
Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire
Time frame: 8 weeks