AsthmaPhase 4NCT01016847
Moderate to Persistent Asthma in the Obese Subject
A Phase 4 study testing Montelukast and Sugar pill in people with Asthma, run by Duke University at 1 site in United States.
Trial summary
Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Montelukast and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2013
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate persistent asthma as defined daily symptoms, nocturnal awakenings >1 time/week but not daily, daily short-acting beta agonist usage
- pre-bronchodilator Force expiratory volume (FEV1)>55% but <90%.
- Subjects must be on controller therapy for asthma with ICS for at least one month prior to enrollment.
- methacholine testing that causes a drop in the FEV1 of 20% (8mg/ml off ICS or 16mg/ml) on ICS within 6 months prior to entry
- physician diagnosis of asthma for at least one year prior to study enrollment.
- Obesity defined as BMI greater than 30.
- subjects must have an Asthma Control Questionnaire (ACQ) score >1.25 on the Juniper Asthma Control Questionnaire (indicating poor asthma control),
- require daily medications for asthma and be compliant with study related medications.
Who cannot join
- Subjects must not have been intubated in the last 5 years or unstable asthma symptoms resulting in significant loss or work or school
- upper or lower respiratory tract infection within 1 month of the study
- use of antibiotics within 4 weeks of the study
- use of oral glucocorticoids within 4 weeks
- use of theophylline
- smoking history greater than 10 pack years or any cigarette use within the past two years
Show all 9Show fewer
- significant non-asthma pulmonary disease or other medical problems
- Subjects planning to undergo gastric bypass surgery within 4 months of the enrollment date will be excluded since weight loss is a potential confounder of asthma control
- Pregnant women will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Asthma Allergy and Airway Center
Durham, North Carolina, 27704
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study to Evaluate the Effect of the Leukotriene Antagonist (Singulair©) Plus Moderate Dose Beclomethasone Compared to High Dose Beclomethasone in Obese Subjects With Moderate Persistent Asthma
Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). The investigators suggested that the addition of Singular (montelukast)[LTRA] to moderate doses of inhaled corticosteroids will improve asthma control. This cross over study will be treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12 weeks.
Read the detailed description
Subjects will enter the 2-week run-in period after meeting eligibility criteria at the screening visit (visit 1). During run-in subjects will have all usual asthma medications discontinued and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out). Subjects will be monitored to rule out any acute infection or symptoms consistent with an exacerbation. The run-in period will be used to assess subject compliance and understanding of study related procedures. Following the run-in, to be eligible for the randomization subjects must have an ACQ score >1.25 on the Juniper Asthma Control Questionnaire.
- Conditions
- Asthma
- Being tested
- Montelukast, Sugar pill
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
10 mg Q day
Sugar pillOther
Sugar pill that looks like Montelukast that will be given Q day
| Study group | Role | What they receive |
|---|---|---|
| leukotriene receptor antagonist (LTRA) montelukast | Active comparator | Montelukast (LTRA) administered with moderate dose of inhaled steroid Receives: Drug: Montelukast |
| Sugar Pill | Placebo comparator | High dose of inhaled steroid administered with sugar pill Receives: Other: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.
Measured: Baseline/randomization to week 16
Secondary outcomes (5)
Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels
Measured: Baseline/randomization to week 16
Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Measured: Baseline/randomization to week 16
Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study
Measured: Baseline/randomization to week 16
Asthma Exacerbation
Asthma exacerbation is defined as the development of an increase in asthma symptoms which results in an increase in the use of asthma medications (typically inhaled corticosteroids and/or parenteral corticosteroids) or the addition of another new asthma medication or antibiotics.
Measured: Baseline/randomization to week 16
Sputum Cell Counts and Differentials
Measured: Baseline/randomization to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Unable to enroll enough study subjects. Study has been terminated
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.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016847
- Sponsor's protocol ID
- Pro00018748
- Status last verified
- Dec 2012
- First submitted
- 19 Oct 2009
- Last updated
- 17 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study to Evaluate the Effect of the Leukotriene Antagonist (Singulair©) Plus Moderate Dose Beclomethasone Compared to High Dose Beclomethasone in Obese Subjects With Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT01016847
- Acronym / sponsor ID
- Pro00018748
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enroll enough study subjects. Study has been terminated
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Nov 2009 (estimated)
- Results
- Posted 17 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obesity is associated with increased airway inflammation and asthma severity that results in suboptimal control of asthma despite therapy with high dose inhaled corticosteroids (ICS). The investigators suggested that the addition of Singular (montelukast)[LTRA] to moderate doses of inhaled corticosteroids will improve asthma control. This cross over study will be treat subjects with moderate dose ICS/LTRA for 12 weeks and high dose ICS with placebo for 12 weeks.
Detailed description
Subjects will enter the 2-week run-in period after meeting eligibility criteria at the screening visit (visit 1). During run-in subjects will have all usual asthma medications discontinued and will be placed on inhaled corticosteroids at moderate doses and leukotriene receptor antagonists will be withdrawn (LTRA wash-out). Subjects will be monitored to rule out any acute infection or symptoms consistent with an exacerbation. The run-in period will be used to assess subject compliance and understanding of study related procedures. Following the run-in, to be eligible for the randomization subjects must have an ACQ score >1.25 on the Juniper Asthma Control Questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| leukotriene receptor antagonist (LTRA) montelukast | Active comparator | Drug: MontelukastMontelukast (LTRA) administered with moderate dose of inhaled steroid |
| Sugar Pill | Placebo comparator | Other: Sugar pillHigh dose of inhaled steroid administered with sugar pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- moderate persistent asthma as defined daily symptoms, nocturnal awakenings >1 time/week but not daily, daily short-acting beta agonist usage
- pre-bronchodilator Force expiratory volume (FEV1)>55% but <90%.
- Subjects must be on controller therapy for asthma with ICS for at least one month prior to enrollment.
- methacholine testing that causes a drop in the FEV1 of 20% (8mg/ml off ICS or 16mg/ml) on ICS within 6 months prior to entry
- physician diagnosis of asthma for at least one year prior to study enrollment.
Key exclusion criteria (9 listed)
- Subjects must not have been intubated in the last 5 years or unstable asthma symptoms resulting in significant loss or work or school
- upper or lower respiratory tract infection within 1 month of the study
- use of antibiotics within 4 weeks of the study
- use of oral glucocorticoids within 4 weeks
- use of theophylline
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 |
|---|---|---|
| Montelukast10 mg Q day | Drug | leukotriene receptor antagonist (LTRA) montelukast |
| Sugar pillSugar pill that looks like Montelukast that will be given Q day | Other | Sugar Pill |
Primary outcome
Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire.
Time frame: Baseline/randomization to week 16
5 secondary outcomes
Serum Adiponectin, Leptin, Tumor Necrosis Alpha (TNF-α) and Interleukin 6 (IL6) Levels
Time frame: Baseline/randomization to week 16
Post Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline/randomization to week 16
Change in Trends in Asthma Control Questionnaire (ACQ ACTQ) Scores Over Duration of the Study
Time frame: Baseline/randomization to week 16
Asthma Exacerbation
Time frame: Baseline/randomization to week 16
Sputum Cell Counts and Differentials
Time frame: Baseline/randomization to week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 and Sugar pill in people with Asthma, run by Duke University 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 8 inclusion and 9 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 17 Nov 2014. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2014). 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?
Determine the Effect of Montelukast / Moderate Dose ICS Versus High Dose ICS on Asthma Control as Measured by the Asthma Control Questionnaire. (time frame: Baseline/randomization to week 16). 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 17 Nov 2014.