AsthmaPhase 4NCT02635334
Asthma in the Elderly: The Effect of Montelukast
A Phase 4 study testing Montelukast 10 mg orally in people with Asthma, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 1 site in United States.
Trial summary
This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the treatment of asthma in subjects who are 12 month old and older. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast 10 mg orally
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Jun 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Asthma diagnosed for at least one year;
- Able to swallow small capsules.
Who cannot join
- Tobacco smoking for more than 10/pack years;
- Previous adverse reaction to montelukast or other leukotriene inhibitor;
- History of hypereosinophilic disorder other than atopic disease;
- Treatment with montelukast within 4 weeks from randomization;
- Asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks from randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Bryn Mawr, Pennsylvania, 19010
About this study
Official title: Asthma in the Elderly: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study of the Effect of Montelukast
This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the treatment of asthma in subjects who are 12 month old and older. This study is being done because there has been no placebo controlled study of montelukast focused on this group of patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger asthmatics. The pathophysiology of asthma in the elderly is typically different than in younger patients. This is a double-blind, placebo-controlled, crossover study. Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco products in their lifetime. After a run-in period of one week, the study subjects will take montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa. Primary objectives of this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily symptom scores, the Asthma Control Test and the number of puffs of albuterol, and spirometric values (FEV1). Secondary objectives include studying whether montelukast affects peripheral blood eosinophils counts and serum IgE levels.
- Conditions
- Asthma
- Being tested
- Montelukast 10 mg orally, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montelukast 10 mg orallyDrug
Also called Singulair
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Montelukast 10 mg daily for 8 weeks | Experimental | Study subjects will take montelukast 10 mg orally daily for 8 weeks Receives: Drug: Montelukast 10 mg orally; Other: Placebo |
| Placebo daily for 8 weeks | Placebo comparator | Study subjects will take placebo orally daily for 8 weeks Receives: Drug: Montelukast 10 mg orally; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of montelukast on asthma symptoms assessed by daily symptom scores.
Measured: 8 weeks
Effect of montelukast on the Asthma Control Test.
Measured: 8 weeks
Effect of montelukast on number of puffs of albuterol used to relieve asthma symptoms.
Measured: 8 weeks
Effect of montelukast on lung capacity assessed by spirometry (FEV1).
Measured: 8 weeks
Secondary outcomes (2)
Effect of montelukast on peripheral blood eosinophils counts.
Measured: 8 weeks
Effect of montelukast on total serum IgE.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Columbo, M.D., Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
- Investigators
- Michele Columbo, M.D., Principal investigator, Rohr and Columbo Asthma, Allergy, and Immunology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635334
- Sponsor's protocol ID
- SSRF2015-01
- Status last verified
- Oct 2016
- First submitted
- 10 Dec 2015
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma in the Elderly: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study of the Effect of Montelukast
- ClinicalTrials.gov ID
- NCT02635334
- Acronym / sponsor ID
- SSRF2015-01
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.University, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Dec 2015 (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.
This is a pilot study of the effect of montelukast in subjects with asthma who are 65 years old and older. Montelukast is a leukotriene receptor antagonist U.S. F.D.A. approved for the treatment of asthma in subjects who are 12 month old and older. This study is being done because there has been no placebo controlled study of montelukast focused on this group of patients. Elderly asthmatics have been mostly ignored in asthma studies. They are more likely to be underdiagnosed, undertreated, and hospitalized for asthma when compared to younger asthmatics. The pathophysiology of asthma in the elderly is typically different than in younger patients. This is a double-blind, placebo-controlled, crossover study. Investigators plan to enroll thirty subjects who have been diagnosed with asthma for at least one year, are non smoker, and did not smoke for more than 10 pack/year of tobacco products in their lifetime. After a run-in period of one week, the study subjects will take montelukast 10 mg orally for 8 weeks first and then placebo for 8 weeks, or vice versa. Primary objectives of this study are to evaluate the effect of montelukast on asthma symptoms assessed by daily symptom scores, the Asthma Control Test and the number of puffs of albuterol, and spirometric values (FEV1). Secondary objectives include studying whether montelukast affects peripheral blood eosinophils counts and serum IgE levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast 10 mg daily for 8 weeks | Experimental | Drug: Montelukast 10 mg orally, Other: PlaceboStudy subjects will take montelukast 10 mg orally daily for 8 weeks |
| Placebo daily for 8 weeks | Placebo comparator | Drug: Montelukast 10 mg orally, Other: PlaceboStudy subjects will take placebo orally daily for 8 weeks |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Asthma diagnosed for at least one year;
- Able to swallow small capsules.
Key exclusion criteria (5 listed)
- Tobacco smoking for more than 10/pack years;
- Previous adverse reaction to montelukast or other leukotriene inhibitor;
- History of hypereosinophilic disorder other than atopic disease;
- Treatment with montelukast within 4 weeks from randomization;
- Asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks from randomization.
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 |
|---|---|---|
| Montelukast 10 mg orallyAlso: Singulair | Drug | Montelukast 10 mg daily for 8 weeks, Placebo daily for 8 weeks |
| Placebo | Other | Montelukast 10 mg daily for 8 weeks, Placebo daily for 8 weeks |
Primary outcome
Effect of montelukast on asthma symptoms assessed by daily symptom scores.
Time frame: 8 weeks
Effect of montelukast on the Asthma Control Test.
Time frame: 8 weeks
Effect of montelukast on number of puffs of albuterol used to relieve asthma symptoms.
Time frame: 8 weeks
Effect of montelukast on lung capacity assessed by spirometry (FEV1).
Time frame: 8 weeks
2 secondary outcomes
Effect of montelukast on peripheral blood eosinophils counts.
Time frame: 8 weeks
Effect of montelukast on total serum IgE.
Time frame: 8 weeks
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 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Michele Columbo, M.D. principal investigator
Rohr and Columbo Asthma, Allergy, and Immunology Specialists
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 10 mg orally in people with Asthma, run by Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C. at 1 site in United States.
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 2 inclusion and 5 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 5 Oct 2016. 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 States. 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?
Effect of montelukast on asthma symptoms assessed by daily symptom scores. (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2016.