AsthmaPhase 2NCT00666679

Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)

A Phase 2 study testing Comparator: mometasone and Comparator: montelukast in people with Asthma, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma. Read more about this study

Who is it for?: Ages 15 to 85 years
Conditions the study is for: Asthma
What is being tested?: Comparator: mometasone and Comparator: montelukast
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 134 participants
Where: No sites listed yet
Study dates: May 2008to Feb 2009
Phase: Phase 2
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 15 to 85 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler
Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator

Who cannot join

Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components
Has required an oral corticosteroid rescue for worsening asthma during the screening period

About this study

Official title: Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma

This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Read the detailed description

During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.

Conditions: Asthma
Being tested: Comparator: mometasone, Comparator: montelukast, Comparator: placebo (unspecified)
Medical subject headings: Asthma

What participants receive

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

Comparator: mometasoneDrug
mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)
Comparator: montelukastDrug
montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)
Comparator: placebo (unspecified)Drug
Placebo (Placebo once-daily, for approximately 2 weeks)

Study groups in NCT00666679
Study group	Role	What they receive
1	Active comparator	mometasone Receives: Drug: Comparator: mometasone
2	Placebo comparator	montelukast followed by placebo; or placebo followed by montelukast. Receives: Drug: Comparator: montelukast; Drug: Comparator: placebo (unspecified)

What is being measured

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

Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.
Measured: Baseline and 2 weeks

Secondary outcomes (2)

Change From Baseline in Daytime Asthma Symptom Score
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.
Measured: Baseline and 2 weeks
Change From Baseline in Nighttime Asthma Symptom Score
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.
Measured: Baseline and 2 weeks

Timeline

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

May 2008Feb 2009

First posted25 Apr 2008 (estimated)
Study startMay 2008
Primary completionFeb 2009
Study completionFeb 2009

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 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00666679
Sponsor's protocol ID: 0476-386
Other IDs: MK0476-386, 2007_654
Status last verified: Feb 2022
First submitted: 23 Apr 2008
Last updated: 10 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Philip G, Villaran C, Shah SR, Vandormael K, Smugar SS, Reiss TF. The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. J Asthma. 2011 Jun;48(5):495-502. doi: 10.3109/02770903.2011.573042. Epub 2011 May 5.
PubMed 21545249

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma
ClinicalTrials.gov ID: NCT00666679
Acronym / sponsor ID: 0476-386
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 25 Apr 2008 (estimated)
Results: Posted 3 Feb 2010

Clinical summary

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

This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Comparator: mometasonemometasone
2	Placebo comparator	Drug: Comparator: montelukast, Drug: Comparator: placebo (unspecified)montelukast followed by placebo; or placebo followed by montelukast.

Who may qualify

Ages: 15 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler
Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator

Key exclusion criteria (2 listed)

Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components
Has required an oral corticosteroid rescue for worsening asthma during the screening period

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
Comparator: mometasonemometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)	Drug	1
Comparator: montelukastmontelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)	Drug	2
Comparator: placebo (unspecified)Placebo (Placebo once-daily, for approximately 2 weeks)	Drug	2

Primary outcome

Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)
Time frame: Baseline and 2 weeks
To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average.

2 secondary outcomes

Change From Baseline in Daytime Asthma Symptom Score
Time frame: Baseline and 2 weeks
Change From Baseline in Nighttime Asthma Symptom Score
Time frame: Baseline and 2 weeks

Results and safety

Results posted to the registry on 3 Feb 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Montelukast + Mometasone Then Placebo + Mometasone	66	62
Placebo + Mometasone Then Montelukast + Mometasone	68	67

Primary outcome: Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation)

Time frame: Baseline and 2 weeks. Least squares mean (95% Confidence Interval). Unit: L (Liter)

Measure	Montelukast + Mometasone n = 127	Placebo + Mometasone n = 127
Value	0.22 (0.15 to 0.30)	0.17 (0.11 to 0.23)

Montelukast + Mometasone vs Placebo + Mometasone: Difference in Least-Squares Means: 0.05 (95% CI 0.00 to 0.09), p = 0.033, Mixed Models Analysis

Population analysed: The analysis was based on the Full analysis set (FAS) population which included all randomized patients who took at least one dose of blinded post randomization study drug (inhaled montelukast or matching placebo) and had a measurement for analysis available in at least one treatment period of the cross-over design.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast + Mometasone	1 of 130 (0.8%)	24 of 130 (18.5%)	Not reported
Placebo + Mometasone	1 of 129 (0.8%)	24 of 129 (18.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21545249Philip G, Villaran C, Shah SR, Vandormael K, Smugar SS, Reiss TF. The efficacy and tolerability of inhaled montelukast plus inhaled mometasone compared with mometasone alone in patients with chronic asthma. J Asthma. 2011 Jun;48(5):495-502. doi: 10.3109/02770903.2011.573042. Epub 2011 May 5.
Individual participant dataSharing planned: No

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Recruiting
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RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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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.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Comparator: mometasone and Comparator: montelukast in people with Asthma, run by Organon and Co.

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 2 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 3 Feb 2010). 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 From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) (time frame: Baseline and 2 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 NCT00666679, 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 10 May 2024.