Acute Asthma ExacerbationPhase 4AcMkNCT01011452
Acute Montelukast in Asthma
A Phase 4 study testing Montelukast in people with Acute Asthma Exacerbation, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
Patients presenting to hospital with an acute asthma exacerbation severe enough to require admission would receive full standard treatment according to British Thoracic Society guidelines in addition they would be offered the opportunity to take part in the study which would requite them to take a capsule of either… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Asthma Exacerbation
- 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
- 87 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2001to Oct 2004
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acute Asthma exacerbation requiring hospitalisation
Who cannot join
- Smoking history greater than or equal to 10 pack years
- Presenting PEFR greater than or equal to 75% predicted / best
- Failure to demonstrate greater than or equal to 15% variability in PEFR or FEV during the study
- Any significant and active pulmonary pathology other than asthma
- Pregnancy or breastfeeding
- Intended pregnancy or inability to take adequate precautions against conception
Show all 11Show fewer
- Patient already on Montelukast
- Patient already on Phenobarbitone
- Patient already on Rifampicin
- Patient already on Phenytoin
- Chronic airflow limitation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospital
Norwich, NR47UY
About this study
Official title: Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma.
Patients presenting to hospital with an acute asthma exacerbation severe enough to require admission would receive full standard treatment according to British Thoracic Society guidelines in addition they would be offered the opportunity to take part in the study which would requite them to take a capsule of either montelukast or placebo.
- Conditions
- Acute Asthma Exacerbation
- Being tested
- Montelukast, Placebo
- Keywords
- Acute Asthma Exacerbation, Montelukast, Management of acute asthma exacerbation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Also called Singulair
1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks
PlaceboDrug
1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Active comparator | 1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks 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.
Difference in peak flow between active and placebo limbs by the morning after randomization
Measured: 24 hours maximum
Secondary outcomes (9)
Time (hours) to achieve PEF and FEV greater than or equal to 75% best achieved in the last 12 months with greater than or equal to 25% diurnal variation
Measured: 24 hours maximum
Time to discharge from hospital
PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up
Proportion of days (post discharge until follow up) with a PEFR of less than or equal to 75%, and less than or equal to 50% best predicted
Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25%
Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit
requirement for further medical intervention / increases in treatment following discharge
Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication
Evaluation of economic costs and savings from the additional treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startMay 2001
- Primary completionAug 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Asthma ExacerbationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk Association of Asthma Nurses, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011452
- Sponsor's protocol ID
- LREC 2000-108
- Acronym
- AcMk
- Status last verified
- Nov 2009
- First submitted
- 10 Nov 2009
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramsay, CF., Oral Motelukast in Patients with Acute Severe Asthma. Abstract NO P3609. ERJ Sept 2007
Ramsay CF, Pearson D, Mildenhall S, Wilson AM. Oral montelukast in acute asthma exacerbations: a randomised, double-blind, placebo-controlled trial. Thorax. 2011 Jan;66(1):7-11. doi: 10.1136/thx.2010.135038. Epub 2010 Oct 18.
PubMed 20956393
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Oral Montelukast as Additional Treatment in the Management of Patients With Acute Severe Asthma.
- ClinicalTrials.gov ID
- NCT01011452
- Acronym / sponsor ID
- AcMk / LREC 2000-108
- Conditions
- Acute Asthma Exacerbation
- Keywords
- Acute Asthma Exacerbation, Montelukast, Management of acute asthma exacerbation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Norfolk Association of Asthma Nurses, Merck Sharp & Dohme LLC
- Study start
- May 2001
- Primary completion
- Aug 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 11 Nov 2009 (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.
Patients presenting to hospital with an acute asthma exacerbation severe enough to require admission would receive full standard treatment according to British Thoracic Society guidelines in addition they would be offered the opportunity to take part in the study which would requite them to take a capsule of either montelukast or placebo.
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 | Active comparator | Drug: Montelukast1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Acute Asthma exacerbation requiring hospitalisation
Key exclusion criteria (11 listed)
- Smoking history greater than or equal to 10 pack years
- Presenting PEFR greater than or equal to 75% predicted / best
- Failure to demonstrate greater than or equal to 15% variability in PEFR or FEV during the study
- Any significant and active pulmonary pathology other than asthma
- Pregnancy or 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: Singulair1 study capsule at study entry Montelukast 10mg and a further study capsule at 10pm for four weeks | Drug | Montelukast |
| Placebo1 placebo capsule at study entry and a further placebo capsule at 10pm for four weeks | Drug | Placebo |
Primary outcome
Difference in peak flow between active and placebo limbs by the morning after randomization
Time frame: 24 hours maximum
9 secondary outcomes
Time (hours) to achieve PEF and FEV greater than or equal to 75% best achieved in the last 12 months with greater than or equal to 25% diurnal variation
Time frame: 24 hours maximum
Time to discharge from hospital
PEF, FEV and FVC (as % best/predicted) the morning following admission and at 4 week clinic follow up
Proportion of days (post discharge until follow up) with a PEFR of less than or equal to 75%, and less than or equal to 50% best predicted
Proportion of days (post discharge until follow up) with a PEFR variability of greater than or equal to 25%
Residual volume as % predicted and RV/TLC% and FEF50 and FEF75 at 4 week out patient visit
requirement for further medical intervention / increases in treatment following discharge
Evaluation of quality of life over the four week out patient follow up period and expressed preference to continue on study medication
Evaluation of economic costs and savings from the additional treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
- Results publicationRamsay, CF., Oral Motelukast in Patients with Acute Severe Asthma. Abstract NO P3609. ERJ Sept 2007
- Derived from this study: PubMed 20956393Ramsay CF, Pearson D, Mildenhall S, Wilson AM. Oral montelukast in acute asthma exacerbations: a randomised, double-blind, placebo-controlled trial. Thorax. 2011 Jan;66(1):7-11. doi: 10.1136/thx.2010.135038. Epub 2010 Oct 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Asthma Exacerbation, run by University of East Anglia 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 11 Nov 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in peak flow between active and placebo limbs by the morning after randomization (time frame: 24 hours maximum). 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 NCT01011452, which also lists 2 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 11 Nov 2009.