Persistent CoughPhase 4MACNCT01279668
Montelukast for Persistent Cough in Young People and Adults
A Phase 4 study testing Montelukast in people with Persistent Cough and Whooping Cough, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient chest clinics. Most coughs are caused by self-limiting viral infections such as the common cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go on for several weeks. Read more about this study
- Who is it for?
- Ages 16 to 49 years
- Conditions the study is for
- Persistent Cough, Whooping Cough
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2011to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or Female, aged 16 years to 49 years inclusive.
- Presenting with a persistent cough of 2-8 weeks' duration without an established diagnosis (e.g. asthma, gastro-oesophageal reflux).
- Able to complete cough diary and study questionnaires.
Who cannot join
- There is a contraindication to montelukast.
- Chronic severe disease which may cause persistent cough (eg cystic fibrosis, bronchiectasis, cardiac failure).
- Immunodeficiency/immunocompromised state.
- Pregnancy.
- Breastfeeding.
- Current smoker (i.e. stopped smoking less than 6 months ago).
- Regular medication associated with persistent cough (ACE inhibitors).
- The individual is in another clinical research study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind Randomised Placebo Controlled Trial of Montelukast in the Treatment of Acute Persistent Cough in Young People and Adults in Primary Care
Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient chest clinics. Most coughs are caused by self-limiting viral infections such as the common cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go on for several weeks. Whooping cough is a common cause of persistent cough in young people and adults. Although the whooping cough vaccine gives lifelong protection against severe infection, it does not appear to give such long-term protection against milder infections, which can make someone cough for many weeks. There are currently no proven efficacious treatments for persistent cough following either a viral infection or infection with whooping cough.
Montelukast is a medication which is already licensed for the treatment of asthma. It works by blocking the action of chemicals called leukotrienes, which make the airways of people with asthma inflamed and sensitive. There is strong evidence to suggest that leukotrienes are also involved in causing persistent cough following viral or whooping cough infection. Montelukast may therefore also help settle persistent coughs in these settings.
Over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks from general practices in England. An oral fluid sample will be taken from each participant to be tested for whooping cough. Participants will be randomly allocated to receive a 28-day course of montelukast or placebo tablets and asked to complete a daily cough diary for two weeks. They will be assessed after two weeks by their GP (face-to-face) and after four weeks by another member of practice clinical staff (telephone). Some participants will be given a 24-hour cough monitor to wear on study entry and at two-week follow-up. This study will be funded by the National Institute for Health Research's School of Primary Care.
- Conditions
- Persistent Cough, Whooping Cough
- Being tested
- Montelukast, Placebo
- Keywords
- Montelukast, Persistent cough, Adults, Double-blind randomised placebo controlled trial
- Medical subject headings
- Chronic Cough, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair
10mg tablets, once per day for 28 days.
PlaceboDrug
tablets, once per day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Experimental | Not described Receives: Drug: Montelukast |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation.
Measured: 2 and 4 weeks post randomisation
Secondary outcomes (11)
Change in Leicester Cough Questionnaire (LCQ) physical, psychological and social domain scores at 2 and 4 weeks post randomisation.
Measured: 2 and 4 weeks post randomisation
Overall cough severity according to cough visual analogue scale (VAS) scores over the 2-week period post randomisation (area under the curve).
Measured: 2 weeks post randomisation
Paroxysmal cough severity over the 2-week period post randomisation (area under the curve).
Measured: 2 weeks post randomisation
Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation.
Measured: 2 and 4 weeks post randomisation
Recruitment rate among young people and adults presenting with acute persistent cough.
Measured: End of study
Follow-up rates at 2 weeks and 4 weeks post randomisation.
Measured: 2 weeks and 4 weeks post randomisation.
Medication adherence rates at 2 and 4 weeks post randomisation.
Measured: 2 and 4 weeks post randomisation
Prevalence of whooping cough among participants.
Measured: End of study
Correlations between subjective cough outcome measures (diary-recorded paroxysms of cough, cough visual analogue scale score and exercise-related cough score) and objective cough frequency measured using the Leicester Cough Monitor.
Measured: 2 and 4 weeks post randomisation
Proportions of participants undergoing further intervention (re-consultation, investigation, prescription of other medication).
Patient notes will be reviewed in this time frame
Measured: 4 - 8 weeks
Proportions of participants with adverse events.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Persistent CoughStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony R Harnden, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279668
- Sponsor's protocol ID
- MAC_001
- Other IDs
- 2010-019647-19
- Acronym
- MAC
- Status last verified
- Oct 2012
- First submitted
- 17 Jan 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harnden A, Grant C, Harrison T, Perera R, Brueggemann AB, Mayon-White R, Mant D. Whooping cough in school age children with persistent cough: prospective cohort study in primary care. BMJ. 2006 Jul 22;333(7560):174-7. doi: 10.1136/bmj.38870.655405.AE. Epub 2006 Jul 7.
PubMed 16829538Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.
PubMed 12668799Wang K, Birring SS, Taylor K, Fry NK, Hay AD, Moore M, Jin J, Perera R, Farmer A, Little P, Harrison TG, Mant D, Harnden A. Montelukast for postinfectious cough in adults: a double-blind randomised placebo-controlled trial. Lancet Respir Med. 2014 Jan;2(1):35-43. doi: 10.1016/S2213-2600(13)70245-5. Epub 2013 Dec 2.
PubMed 24461900
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomised Placebo Controlled Trial of Montelukast in the Treatment of Acute Persistent Cough in Young People and Adults in Primary Care
- ClinicalTrials.gov ID
- NCT01279668
- Acronym / sponsor ID
- MAC / MAC_001
- Conditions
- Persistent Cough, Whooping Cough
- Keywords
- Montelukast, Persistent cough, Adults, Double-blind randomised placebo controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 276 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persistent cough is a common symptom, accounting for about 20% of referrals to outpatient chest clinics. Most coughs are caused by self-limiting viral infections such as the common cold. However, 1 in 4 people with a viral infection develop a persistent cough, which can go on for several weeks. Whooping cough is a common cause of persistent cough in young people and adults. Although the whooping cough vaccine gives lifelong protection against severe infection, it does not appear to give such long-term protection against milder infections, which can make someone cough for many weeks. There are currently no proven efficacious treatments for persistent cough following either a viral infection or infection with whooping cough.
Montelukast is a medication which is already licensed for the treatment of asthma. It works by blocking the action of chemicals called leukotrienes, which make the airways of people with asthma inflamed and sensitive. There is strong evidence to suggest that leukotrienes are also involved in causing persistent cough following viral or whooping cough infection. Montelukast may therefore also help settle persistent coughs in these settings.
Over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks from general practices in England. An oral fluid sample will be taken from each participant to be tested for whooping cough. Participants will be randomly allocated to receive a 28-day course of montelukast or placebo tablets and asked to complete a daily cough diary for two weeks. They will be assessed after two weeks by their GP (face-to-face) and after four weeks by another member of practice clinical staff (telephone). Some participants will be given a 24-hour cough monitor to wear on study entry and at two-week follow-up. This study will be funded by the National Institute for Health Research's School of Primary Care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: Montelukast |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or Female, aged 16 years to 49 years inclusive.
- Presenting with a persistent cough of 2-8 weeks' duration without an established diagnosis (e.g. asthma, gastro-oesophageal reflux).
- Able to complete cough diary and study questionnaires.
Key exclusion criteria (8 listed)
- There is a contraindication to montelukast.
- Chronic severe disease which may cause persistent cough (eg cystic fibrosis, bronchiectasis, cardiac failure).
- Immunodeficiency/immunocompromised state.
- Pregnancy.
- Breastfeeding.
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 |
|---|---|---|
| MontelukastAlso: Singulair10mg tablets, once per day for 28 days. | Drug | Montelukast |
| Placebotablets, once per day for 28 days. | Drug | Placebo |
Primary outcome
Change in Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation.
Time frame: 2 and 4 weeks post randomisation
11 secondary outcomes
Change in Leicester Cough Questionnaire (LCQ) physical, psychological and social domain scores at 2 and 4 weeks post randomisation.
Time frame: 2 and 4 weeks post randomisation
Overall cough severity according to cough visual analogue scale (VAS) scores over the 2-week period post randomisation (area under the curve).
Time frame: 2 weeks post randomisation
Paroxysmal cough severity over the 2-week period post randomisation (area under the curve).
Time frame: 2 weeks post randomisation
Proportions of participants reporting cessation of cough at 2 and 4 weeks post randomisation.
Time frame: 2 and 4 weeks post randomisation
Recruitment rate among young people and adults presenting with acute persistent cough.
Time frame: End of study
Follow-up rates at 2 weeks and 4 weeks post randomisation.
Time frame: 2 weeks and 4 weeks post randomisation.
Medication adherence rates at 2 and 4 weeks post randomisation.
Time frame: 2 and 4 weeks post randomisation
Prevalence of whooping cough among participants.
Time frame: End of study
Correlations between subjective cough outcome measures (diary-recorded paroxysms of cough, cough visual analogue scale score and exercise-related cough score) and objective cough frequency measured using the Leicester Cough Monitor.
Time frame: 2 and 4 weeks post randomisation
Proportions of participants undergoing further intervention (re-consultation, investigation, prescription of other medication).
Time frame: 4 - 8 weeks
Proportions of participants with adverse events.
Time frame: End of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
- Background: PubMed 16829538Harnden A, Grant C, Harrison T, Perera R, Brueggemann AB, Mayon-White R, Mant D. Whooping cough in school age children with persistent cough: prospective cohort study in primary care. BMJ. 2006 Jul 22;333(7560):174-7. doi: 10.1136/bmj.38870.655405.AE. Epub 2006 Jul 7.
- Background: PubMed 12668799Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.
- Derived from this study: PubMed 24461900Wang K, Birring SS, Taylor K, Fry NK, Hay AD, Moore M, Jin J, Perera R, Farmer A, Little P, Harrison TG, Mant D, Harnden A. Montelukast for postinfectious cough in adults: a double-blind randomised placebo-controlled trial. Lancet Respir Med. 2014 Jan;2(1):35-43. doi: 10.1016/S2213-2600(13)70245-5. Epub 2013 Dec 2.
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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.
Anthony R Harnden principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast in people with Persistent Cough and Whooping Cough, run by University of Oxford 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Oct 2012. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 Leicester Cough Questionnaire (LCQ) total score at 2 and 4 weeks post randomisation. (time frame: 2 and 4 weeks post randomisation). 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 NCT01279668, which also lists 3 linked publications.
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 10 Oct 2012.