Chronic AsthmaPhase 1NCT00739297

The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

A Phase 1 study testing Comparator: montelukast in people with Chronic Asthma, run by Organon and Co.

Completed

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

Trial summary

This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma. Read more about this study

Who is it for?: Ages 15 to 65 years
Conditions the study is for: Chronic Asthma
What is being tested?: Comparator: montelukast
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: No sites listed yet
Study dates: Jul 2008to Dec 2008
Phase: Phase 1
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 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

A person is 15 to 65 years of age. A person has had chronic asthma for at least one year

Who cannot join

A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)

About this study

Official title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma

This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

Conditions: Chronic Asthma
Being tested: Comparator: montelukast, Comparator: placebo
Keywords: Chronic asthma

What participants receive

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

Comparator: montelukastDrug
Also called SINGULAIR®, PROAIR® HFA
5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.
Comparator: placeboDrug
5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.

Study groups in NCT00739297
Study group	Role	What they receive
1	Placebo comparator	montelukast Placebo Receives: Drug: Comparator: montelukast; Drug: Comparator: placebo
2	Experimental	montelukast Receives: Drug: Comparator: montelukast
3	Experimental	montelukast Receives: Drug: Comparator: montelukast
4	Experimental	montelukast Receives: Drug: Comparator: montelukast

What is being measured

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

Change From Baseline in FEV1 Over 4 Hours
FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
Measured: 0 (=baseline) to 4 hours after treatment with montelukast

Secondary outcomes (1)

Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration
FEV1 measurements taken at 0 (=baseline), 15, 30, 60, and 90 minutes after albuterol/placebo administration contributed to the average change from baseline over 90 minutes. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.
Measured: 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast

Timeline

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

Jul 2008Dec 2008

First posted21 Aug 2008 (estimated)
Study startJul 2008
Primary completionDec 2008
Study completionDec 2008

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 Chronic 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00739297
Sponsor's protocol ID: 0476-388
Other IDs: MK0476-388, 2008_542
Status last verified: Feb 2022
First submitted: 19 Aug 2008
Last updated: 9 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Philip G, Pedinoff A, Vandormael K, Tymofyeyev Y, Smugar SS, Reiss TF, Korenblat PE. A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma. J Asthma. 2010 Dec;47(10):1078-84. doi: 10.3109/02770903.2010.520100. Epub 2010 Nov 3.
PubMed 20936994

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

Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
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THERMotherapy Against Persistent Bacterial LUNG Infections
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Reducing Exposure With Air Cleaners and Technology
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RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
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Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic

All Chronic Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Bronchodilatory Effect of MK0476 in Patients With Chronic Asthma
ClinicalTrials.gov ID: NCT00739297
Acronym / sponsor ID: 0476-388
Conditions: Chronic Asthma
Keywords: Chronic asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 21 Aug 2008 (estimated)
Results: Posted 9 Apr 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 will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Placebo comparator	Drug: Comparator: montelukast, Drug: Comparator: placebomontelukast Placebo
2	Experimental	Drug: Comparator: montelukastmontelukast
3	Experimental	Drug: Comparator: montelukastmontelukast
4	Experimental	Drug: Comparator: montelukastmontelukast

Who may qualify

Ages: 15 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

A person is 15 to 65 years of age. A person has had chronic asthma for at least one year

Key exclusion criteria (2 listed)

A person is a smoker or has smoked more that a pack a day for more than 10 years before stopping
A person has other lung disorders such as COPD (chronic obstructive pulmonary disorder)

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: montelukastAlso: SINGULAIR®, PROAIR® HFA5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.	Drug	1, 2, 3, 4
Comparator: placebo5 Period, Cross-over, Dose-Ranging study. Period I: no treatment. Periods II-V: Single-dose administration of inhaled montelukast (using doses as low as 25 mcg, to as high as 1000 mcg), or montelukast placebo. Two puffs of albuterol or albuterol placebo will be given four hours after montelukast/montelukast placebo.	Drug	1

Primary outcome

Change From Baseline in FEV1 Over 4 Hours
Time frame: 0 (=baseline) to 4 hours after treatment with montelukast
FEV1 measurements taken at 0 (=baseline), 10, 20, 30, 45, 60, 120, 180 and 240 minutes contributed to the average change from baseline over 4 hours. The number of minutes between consecutive measurements was used as weighting factor. The time-weighted average change was standardized by dividing by the time associated with the last measurement.

1 secondary outcome

Change From Baseline in FEV1 Over 90 Minutes After Albuterol/Placebo Administration
Time frame: 4 hours (equals time point at which albuterol or albuterol placebo is administered) to 5.5 hours after treatment with montelukast

Results and safety

Results posted to the registry on 9 Apr 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
Placebo	17	17
25 mcg Montelukast	11	11
100 mcg Montelukast	6	6
250 mcg Montelukast	19	19
500 mcg Montelukast	6	6
1000 mcg Montelukast	9	9
Total	68	68

Primary outcome: Change From Baseline in FEV1 Over 4 Hours

Time frame: 0 (=baseline) to 4 hours after treatment with montelukast. Least squares mean (95% Confidence Interval). Unit: L (Liter)

Measure	Placebo n = 67	25 mcg Montelukast n = 42	100 mcg Montelukast n = 30	250 mcg Montelukast n = 66	500 mcg Montelukast n = 25	1000 mcg Montelukast n = 36
Value	0.03 (-0.03 to 0.10)	0.07 (0.00 to 0.14)	0.13 (0.06 to 0.20)	0.10 (0.04 to 0.16)	0.09 (0.01 to 0.16)	0.12 (0.05 to 0.19)

Placebo vs 25 mcg Montelukast: Difference in Least-Squares Means: 0.04 (95% CI -0.01 to 0.08)
Placebo vs 100 mcg Montelukast: Difference in Least-Squares Means: 0.10 (95% CI 0.04 to 0.15)
Placebo vs 250 mcg Montelukast: Difference in Least-Squares Means: 0.06 (95% CI 0.02 to 0.11)

Population analysed: Full analysis set (FAS) population which included all randomized patients who took at least one dose of post randomization study drug (Montelukast or placebo) at either of the intervention visits and had a measurement for analysis available in at least one treatment period of the cross-over design.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 67 (0%)	4 of 67 (6%)	Not reported
25 mcg Montelukast	0 of 41 (0%)	1 of 41 (2.4%)	Not reported
100 mcg Montelukast	0 of 30 (0%)	0 of 30 (0%)	Not reported
250 mcg Montelukast	0 of 66 (0%)	3 of 66 (4.5%)	Not reported
500 mcg Montelukast	0 of 25 (0%)	3 of 25 (12%)	Not reported
1000 mcg Montelukast	0 of 36 (0%)	0 of 36 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20936994Philip G, Pedinoff A, Vandormael K, Tymofyeyev Y, Smugar SS, Reiss TF, Korenblat PE. A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma. J Asthma. 2010 Dec;47(10):1078-84. doi: 10.3109/02770903.2010.520100. Epub 2010 Nov 3.
Individual participant dataSharing planned: No

Related trials for Chronic Asthma

Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
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Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic

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 1 study testing Comparator: montelukast in people with Chronic 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 1 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 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 9 Apr 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 Over 4 Hours (time frame: 0 (=baseline) to 4 hours after treatment with montelukast). 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 NCT00739297, 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 9 May 2024.