AsthmaPhase 3NCT00911547

The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

A Phase 3 study testing montelukast sodium and beclomethasone 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.

Trial summary

This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone. Read more about this study

Who is it for?: Ages 15 to 85 years
Conditions the study is for: Asthma
What is being tested?: montelukast sodium and beclomethasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 642 participants
Where: No sites listed yet
Study dates: Mar 1995to May 1996
Phase: Phase 3
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

Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
Patient was a nonsmoker
Patient was in good general health (except for asthma)

Who cannot join

Patient was hospitalized
Patient was female who was less than 8 weeks postpartum or breast feeding
Patient planned to move or vacation away during the study
Patient had major surgery within 4 weeks the past 4 weeks
Patient has donated blood or participated in a clinical trial within the past 4 weeks
Patient was a regular user or recent abuser of alcohol or illicit drugs
Patient was 40% over or under normal weight for height

About this study

Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients

This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.

Conditions: Asthma
Being tested: montelukast sodium, beclomethasone, Placebo inhaler, placebo tablet
Keywords: chronic asthma
Medical subject headings: Asthma

What participants receive

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

montelukast sodiumDrug
Also called MK0476
10 mg tablet taken once daily at bedtime for 16 weeks
beclomethasoneDrug
200 ug inhaled, taken twice daily for 16 weeks
Placebo inhalerDrug
placebo inhaler taken twice daily for 16 weeks
placebo tabletDrug
placebo tablet taken once daily at bedtime for 16 weeks

Study groups in NCT00911547
Study group	Role	What they receive
1	Experimental	Montelukast + Beclomethasone Receives: Drug: montelukast sodium; Drug: beclomethasone
2	Experimental	Montelukast + Placebo inhaler Receives: Drug: montelukast sodium; Drug: Placebo inhaler
3	Experimental	Placebo tablet + Beclomethasone Receives: Drug: beclomethasone; Drug: placebo tablet
4	Placebo comparator	Placebo tablet + Placebo inhaler Receives: Drug: Placebo inhaler; Drug: placebo tablet

What is being measured

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

Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma
Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups
Measured: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma
The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.
The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits.
Measured: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Secondary outcomes (3)

Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use
Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.
Measured: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma
Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.
Measured: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only
Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, "Did you wake up with asthma symptoms?" (no, once, more than once, awake "all night"), were assigned numerical values (0, 1, 2, 3, respectively).
The average score for the visit was determined by averaging the daily scores over all days between consecutive visits.
Measured: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Timeline

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

Mar 1995May 1996

First posted2 Jun 2009 (estimated)
Study startMar 1995
Primary completionApr 1996
Study completionMay 1996

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 642 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00911547
Sponsor's protocol ID: 0476-029
Other IDs: 2009_596
Status last verified: Feb 2022
First submitted: 29 May 2009
Last updated: 3 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Publications

Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet JC, Peszek I, Zhang J, Reiss TF. Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group. Am J Respir Crit Care Med. 1999 Dec;160(6):1862-8. doi: 10.1164/ajrccm.160.6.9803042.
PubMed 10588598

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

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
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
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients
ClinicalTrials.gov ID: NCT00911547
Acronym / sponsor ID: 0476-029
Conditions: Asthma
Keywords: chronic asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 642 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Mar 1995
Primary completion: Apr 1996 (actual)
Study completion: May 1996 (actual)
First posted: 2 Jun 2009 (estimated)
Results: Posted 9 Jun 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 investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.

Study design

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

Arm	Type	Receives
1	Experimental	Drug: montelukast sodium, Drug: beclomethasoneMontelukast + Beclomethasone
2	Experimental	Drug: montelukast sodium, Drug: Placebo inhalerMontelukast + Placebo inhaler
3	Experimental	Drug: beclomethasone, Drug: placebo tabletPlacebo tablet + Beclomethasone
4	Placebo comparator	Drug: Placebo inhaler, Drug: placebo tabletPlacebo tablet + Placebo inhaler

Who may qualify

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

Key inclusion criteria (3 listed)

Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
Patient was a nonsmoker
Patient was in good general health (except for asthma)

Key exclusion criteria (7 listed)

Patient was hospitalized
Patient was female who was less than 8 weeks postpartum or breast feeding
Patient planned to move or vacation away during the study
Patient had major surgery within 4 weeks the past 4 weeks
Patient has donated blood or participated in a clinical trial within the past 4 weeks

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 sodiumAlso: MK047610 mg tablet taken once daily at bedtime for 16 weeks	Drug	1, 2
beclomethasone200 ug inhaled, taken twice daily for 16 weeks	Drug	1, 3
Placebo inhalerplacebo inhaler taken twice daily for 16 weeks	Drug	2, 4
placebo tabletplacebo tablet taken once daily at bedtime for 16 weeks	Drug	3, 4

Primary outcome

Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma
Time frame: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma
Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary. The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits.

3 secondary outcomes

Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use
Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma
Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only
Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Results and safety

Results posted to the registry on 9 Jun 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	48	37
Montelukast	201	159
Beclomethasone	200	178
Montelukast+ Beclomethasone	193	177

Primary outcome: Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma

Time frame: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups. Least squares mean (95% Confidence Interval). Unit: Percentage of Change

Measure	Placebo n = 44	Montelukast n = 183	Beclomethasone n = 198	Montelukast+ Beclomethasone n = 191
Value	-11.96 (-16.28 to -7.64)	-5.31 (-7.32 to -3.30)	0.72 (-0.89 to 2.33)	5.08 (3.43 to 6.74)

Population analysed: Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values were imputed. Data collected during discontinuation and unscheduled visits were included the analysis. Differences between treatments are evaluated based on LS means

Primary outcome: Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma

Time frame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups. Least squares mean (95% Confidence Interval). Unit: Units on a Scale

Measure	Placebo n = 44	Montelukast n = 183	Beclomethasone n = 198	Montelukast+ Beclomethasone n = 191
Value	0.31 (0.08 to 0.54)	0.27 (0.17 to 0.38)	-0.02 (-0.10 to 0.06)	-0.13 (-0.22 to -0.05)

Population analysed: Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Over 16 weeks of treatment and for 14 days post-treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 48 (2.1%)	36 of 48 (75%)	Not reported
Montelukast	4 of 201 (2%)	150 of 201 (74.6%)	Not reported
Beclomethasone	6 of 200 (3%)	139 of 200 (69.5%)	Not reported
Montelukast+ Beclomethasone	1 of 193 (0.5%)	123 of 193 (63.7%)	Not reported

Limitations and caveats (from the sponsor): Efficacy over 16 weeks of treatment for Beclo and MK+Beclo groups, and last 10 weeks for Placebo and MK groups to minimize confounding effect of beclo in 1st 4 weeks of treatment and to allow beclo washout.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 10588598Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet JC, Peszek I, Zhang J, Reiss TF. Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group. Am J Respir Crit Care Med. 1999 Dec;160(6):1862-8. doi: 10.1164/ajrccm.160.6.9803042.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
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
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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 3 study testing montelukast sodium and beclomethasone 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 3 inclusion and 7 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 3 Feb 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Jun 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?

Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma (time frame: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups). The study lists 2 primary outcomes in all. 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 NCT00911547, 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 3 Feb 2022.