CoughPhase 3NCT00668317

Bronchial Hyper-responsiveness in Reflux Cough

A Phase 3 study testing Omeprazole and Ranitidine in people with Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Cough
What is being tested?: Omeprazole and Ranitidine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2006to Jan 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital
Cottingham, East Yorkshire, HU16 5JQ

Other trials in United Kingdom

About this study

Official title: An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness

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.

Conditions: Cough
Being tested: Omeprazole, Ranitidine
Keywords: Hyper-responsiveness, reflux cough
Medical subject headings: Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OmeprazoleDrug
Also called Losec
20 mg BD tablet 8 weeks duration
RanitidineDrug
Also called Zantac
300 mg od nocte tablet 8weeks duration

Study groups in NCT00668317
Study group	Role	What they receive
omeprazole and ranitidine	Other	20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte Receives: Drug: Omeprazole; Drug: Ranitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: baseline and 8 weeks

Secondary outcomes (1)

Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Jan 2010

First posted29 Apr 2008 (estimated)
Study startSep 2006
Primary completionSep 2009
Study completionJan 2010

Why it stopped: Primary care physicians began prescribing antacid therapy for chronic cough

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CoughStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00668317
Sponsor's protocol ID: 2006-004102-13
Status last verified: Jul 2019
First submitted: 24 Apr 2008
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Morice AH, Kastelik JA, Thompson R. Cough challenge in the assessment of cough reflex. Br J Clin Pharmacol. 2001 Oct;52(4):365-75. doi: 10.1046/j.0306-5251.2001.01475.x. No abstract available.
PubMed 11678780

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cough trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8 Week Non-selected Cohort Study to Investigate Whether the Treatment of Reflux Induced Cough Alters Associated Bronchial Hyper-responsiveness
ClinicalTrials.gov ID: NCT00668317
Acronym / sponsor ID: 2006-004102-13
Conditions: Cough
Keywords: Hyper-responsiveness, reflux cough
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Primary care physicians began prescribing antacid therapy for chronic cough
Enrolment: 5 participants (actual)
Lead sponsor: Hull University Teaching Hospitals NHS TrustOther government
Study start: Sep 2006
Primary completion: Sep 2009 (actual)
Study completion: Jan 2010 (actual)
First posted: 29 Apr 2008 (estimated)
Results: Posted 16 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
omeprazole and ranitidine	Other	Drug: Omeprazole, Drug: Ranitidine20 mg oralomeprazole oral tablet twice daily and ranitidine 300 mg oral tablet once daily nocte

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OmeprazoleAlso: Losec20 mg BD tablet 8 weeks duration	Drug	omeprazole and ranitidine
RanitidineAlso: Zantac300 mg od nocte tablet 8weeks duration	Drug	omeprazole and ranitidine

Primary outcome

Change in Methacholine Sensitivity
Time frame: 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

1 secondary outcome

Improvement in Cough Symptoms Measured Using Leicester Cough Questionnaire
Time frame: 8 weeks

Results and safety

Results posted to the registry on 16 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Antacid Therapy	5	3

Primary outcome: Change in Methacholine Sensitivity

Time frame: baseline and 8 weeks. Mean (Standard Deviation). Unit: mg/ml

Measure	Omeprazole and Ranitidine n = 3
Value	0.598 (0.479)

Population analysed: 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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 week. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Antacid Therapy	0 of 3 (0%)	0 of 3 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11678780Morice AH, Kastelik JA, Thompson R. Cough challenge in the assessment of cough reflex. Br J Clin Pharmacol. 2001 Oct;52(4):365-75. doi: 10.1046/j.0306-5251.2001.01475.x. No abstract available.
Publication LinkLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alyn H Morice, Professor principal investigator

Hull University Teaching Hospitals NHS Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omeprazole and Ranitidine in people with Cough, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Methacholine Sensitivity (time frame: baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00668317, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.