Trial Outcomes & Findings for Bronchial Hyper-responsiveness in Reflux Cough (NCT NCT00668317)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

5 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2019-07-23

Participant Flow

Patients recruited at the cough clinic at castleHill Hospital

Patients had to have a positive methacholine challenge, and reflux associated chronic cough

Participant milestones

Participant milestones
Measure	Antacid Therapy Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
Overall Study STARTED	5
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Antacid Therapy Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
Overall Study Adverse Event	2

Baseline Characteristics

Bronchial Hyper-responsiveness in Reflux Cough

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Antacid Therapy n=5 Participants Therapy with omeprazole 20 mg BD and Ranitidine 300mg od nocte
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49.8 years STANDARD_DEVIATION 8.53 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United Kingdom	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Omeprazole and Ranitidine n=3 Participants Therapy with omeprazole 20 mg twice a day (BD) and Ranitidine 300mg once a day (od) at night (nocte)
Change in Methacholine Sensitivity	0.598 mg/ml Standard Deviation 0.479

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome data not reported

Adverse Events

Antacid Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical trials Manager

Hull and East Yorkshire Hospitals Trust

Phone: 01482 624067

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place