Trial Outcomes & Findings for A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301) (NCT NCT00117338)
NCT ID: NCT00117338
Last Updated: 2024-05-10
Results Overview
Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.
COMPLETED
PHASE3
276 participants
Baseline and (time weighted average over) 60 Minutes
2024-05-10
Participant Flow
Phase III World Wide (U.S., Europe, Asia, South America, and Lithuania) Multicenter Study. Study Start Date: July 2005 Primary Completion Date: March 2008 Study Completion Date: March 2008
Participant milestones
| Measure |
Montelukast Intravenous (IV) 5.25 mg
|
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
131
|
|
Overall Study
COMPLETED
|
140
|
127
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Montelukast Intravenous (IV) 5.25 mg
|
Placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Did not meet Inclusion Criteria
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
Baseline Characteristics
A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)
Baseline characteristics by cohort
| Measure |
Montelukast Intravenous (IV) 5.25 mg
n=145 Participants
|
Placebo
n=131 Participants
|
Total
n=276 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity
Hispanic
|
59 participants
n=113 Participants
|
53 participants
n=163 Participants
|
112 participants
n=160 Participants
|
|
Race/Ethnicity
Asian
|
18 participants
n=113 Participants
|
18 participants
n=163 Participants
|
36 participants
n=160 Participants
|
|
Race/Ethnicity
Multi-Racial
|
34 participants
n=113 Participants
|
27 participants
n=163 Participants
|
61 participants
n=160 Participants
|
|
Race/Ethnicity
Other
|
0 participants
n=113 Participants
|
1 participants
n=163 Participants
|
1 participants
n=160 Participants
|
|
Baseline FEV 1 (L)
|
1.06 Liters
STANDARD_DEVIATION 0.5 • n=113 Participants
|
1.00 Liters
STANDARD_DEVIATION 0.5 • n=163 Participants
|
1.0 Liters
STANDARD_DEVIATION 0.5 • n=160 Participants
|
|
Age, Continuous
|
9.2 years
STANDARD_DEVIATION 2.36 • n=113 Participants
|
8.9 years
STANDARD_DEVIATION 2.32 • n=163 Participants
|
9.1 years
STANDARD_DEVIATION 2.34 • n=160 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=113 Participants
|
50 Participants
n=163 Participants
|
105 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
90 Participants
n=113 Participants
|
81 Participants
n=163 Participants
|
171 Participants
n=160 Participants
|
|
Race/Ethnicity
White (Non-Hispanic)
|
16 participants
n=113 Participants
|
16 participants
n=163 Participants
|
32 participants
n=160 Participants
|
|
Race/Ethnicity
Black
|
18 participants
n=113 Participants
|
16 participants
n=163 Participants
|
34 participants
n=160 Participants
|
|
Baseline FEV1 (Percent predicted)
|
51.8 Percent
STANDARD_DEVIATION 16.8 • n=113 Participants
|
50.6 Percent
STANDARD_DEVIATION 17.4 • n=163 Participants
|
51.2 Percent
STANDARD_DEVIATION 17.1 • n=160 Participants
|
PRIMARY outcome
Timeframe: Baseline and (time weighted average over) 60 MinutesPopulation: Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.
Outcome measures
| Measure |
Montelukast Intravenous (IV) 5.25 mg
n=144 Participants
|
Placebo
n=128 Participants
|
|---|---|---|
|
Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
|
0.08 Liters
Interval 0.02 to 0.13
|
0.07 Liters
Interval 0.01 to 1.12
|
SECONDARY outcome
Timeframe: Baseline and 60 minutesPopulation: Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
Change from baseline in modified pulmonary index \[mPI\] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12. The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use.
Outcome measures
| Measure |
Montelukast Intravenous (IV) 5.25 mg
n=143 Participants
|
Placebo
n=128 Participants
|
|---|---|---|
|
Change From Baseline in Modified Pulmonary Index [mPI] Score
|
-2.95 Score on a scale
Interval -3.26 to -2.63
|
-2.96 Score on a scale
Interval -3.29 to -2.63
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: Full Analysis Set (FAS). At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of treatment failure endpoint. Baseline FEV1 measurement was also required to assess this endpoint since it was included in the model.
Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration.
Outcome measures
| Measure |
Montelukast Intravenous (IV) 5.25 mg
n=144 Participants
|
Placebo
n=128 Participants
|
|---|---|---|
|
Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
Hospitalization
|
28 Participants
|
33 Participants
|
|
Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
Decision to Discharge Home not Reached by 2 Hours
|
37 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline and (time-weighed average over) 45 MinutesPopulation: Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.
Outcome measures
| Measure |
Montelukast Intravenous (IV) 5.25 mg
n=142 Participants
|
Placebo
n=127 Participants
|
|---|---|---|
|
Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration
|
0.07 Liters
Interval 0.02 to 0.12
|
0.05 Liters
Interval 0.0 to 0.11
|
SECONDARY outcome
Timeframe: Baseline and (time-weighted average over) 30 MinutesPopulation: Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.
Outcome measures
| Measure |
Montelukast Intravenous (IV) 5.25 mg
n=140 Participants
|
Placebo
n=125 Participants
|
|---|---|---|
|
Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration
|
0.06 Liters
Interval 0.01 to 0.12
|
0.05 Liters
Interval 0.0 to 0.11
|
SECONDARY outcome
Timeframe: Baseline and 15 MinutesPopulation: Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.
Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value
Outcome measures
| Measure |
Montelukast Intravenous (IV) 5.25 mg
n=121 Participants
|
Placebo
n=115 Participants
|
|---|---|---|
|
Change in FEV1 After 15 Minutes Following the End of Study Drug Administration
|
0.06 Liters
Interval 0.01 to 0.1
|
0.01 Liters
Interval -0.03 to 0.06
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: At least one post-randomization measurement obtained subsequent to at least one dose of study treatment was required for inclusion in the analysis of total doses of Beta-Agonist (mg) endpoint.
Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.
Outcome measures
| Measure |
Montelukast Intravenous (IV) 5.25 mg
n=144 Participants
|
Placebo
n=127 Participants
|
|---|---|---|
|
Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration
|
1.0 mg
Interval 0.0 to 4.3
|
0.6 mg
Interval 0.0 to 3.8
|
Adverse Events
Montelukast Intravenous (IV) 5.25 mg
Placebo
Serious adverse events
| Measure |
Montelukast Intravenous (IV) 5.25 mg
|
Placebo
|
|---|---|---|
|
Infections and infestations
Any Infections And Infestations
|
0.69%
1/145
|
0.00%
0/131
|
|
Infections and infestations
Pneumonia
|
0.69%
1/145
|
0.00%
0/131
|
|
Injury, poisoning and procedural complications
Any Injury, Poisoning And Procedural Complications
|
0.00%
0/145
|
0.76%
1/131
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/145
|
0.76%
1/131
|
|
Respiratory, thoracic and mediastinal disorders
Any Respiratory, Thoracic And Mediastinal Disorders
|
1.4%
2/145
|
0.76%
1/131
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/145
|
0.76%
1/131
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic Crisis
|
1.4%
2/145
|
0.00%
0/131
|
Other adverse events
| Measure |
Montelukast Intravenous (IV) 5.25 mg
|
Placebo
|
|---|---|---|
|
Cardiac disorders
Any Cardiac Disorders
|
0.69%
1/145
|
0.00%
0/131
|
|
Cardiac disorders
Tachycardia
|
0.69%
1/145
|
0.00%
0/131
|
|
Gastrointestinal disorders
Any Gastrointestinal Disorders
|
3.4%
5/145
|
4.6%
6/131
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/145
|
0.76%
1/131
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.4%
2/145
|
0.00%
0/131
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/145
|
0.76%
1/131
|
|
Gastrointestinal disorders
Diarrhoea
|
0.69%
1/145
|
0.76%
1/131
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.69%
1/145
|
0.00%
0/131
|
|
Gastrointestinal disorders
Nausea
|
0.69%
1/145
|
0.76%
1/131
|
|
Gastrointestinal disorders
Vomiting
|
0.69%
1/145
|
1.5%
2/131
|
|
General disorders
Any General Disorders And Administration Site Conditions
|
1.4%
2/145
|
0.76%
1/131
|
|
General disorders
Chest Pain
|
0.69%
1/145
|
0.00%
0/131
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/145
|
0.76%
1/131
|
|
General disorders
Infusion Site Pain
|
0.69%
1/145
|
0.00%
0/131
|
|
Infections and infestations
Any Infections And Infestations
|
3.4%
5/145
|
3.8%
5/131
|
|
Infections and infestations
Bronchitis Bacterial
|
0.69%
1/145
|
0.00%
0/131
|
|
Infections and infestations
Gastroenteritis
|
0.69%
1/145
|
0.00%
0/131
|
|
Infections and infestations
Influenza
|
0.00%
0/145
|
0.76%
1/131
|
|
Infections and infestations
Nasopharyngitis
|
0.69%
1/145
|
1.5%
2/131
|
|
Infections and infestations
Pharyngitis
|
0.69%
1/145
|
0.00%
0/131
|
|
Infections and infestations
Rhinitis
|
0.00%
0/145
|
0.76%
1/131
|
|
Infections and infestations
Sinusitis
|
0.00%
0/145
|
1.5%
2/131
|
|
Infections and infestations
Tonsillitis
|
0.69%
1/145
|
0.00%
0/131
|
|
Musculoskeletal and connective tissue disorders
Any Musculoskeletal And Connective Tissue Disorders
|
0.69%
1/145
|
0.76%
1/131
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/145
|
0.76%
1/131
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.69%
1/145
|
0.00%
0/131
|
|
Nervous system disorders
Any Nervous System Disorders
|
4.1%
6/145
|
1.5%
2/131
|
|
Nervous system disorders
Dizziness
|
0.00%
0/145
|
0.76%
1/131
|
|
Nervous system disorders
Headache
|
3.4%
5/145
|
0.76%
1/131
|
|
Nervous system disorders
Syncope Vasovagal
|
0.69%
1/145
|
0.00%
0/131
|
|
Respiratory, thoracic and mediastinal disorders
Any Respiratory, Thoracic And Mediastinal Disorders
|
3.4%
5/145
|
6.9%
9/131
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.8%
4/145
|
5.3%
7/131
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.69%
1/145
|
0.00%
0/131
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/145
|
1.5%
2/131
|
|
Skin and subcutaneous tissue disorders
Any Skin And Subcutaneous Tissue Disorders
|
0.00%
0/145
|
1.5%
2/131
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/145
|
0.76%
1/131
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/145
|
0.76%
1/131
|
|
Vascular disorders
Any Vascular Disorders
|
0.00%
0/145
|
0.76%
1/131
|
|
Vascular disorders
Diastolic Hypotension
|
0.00%
0/145
|
0.76%
1/131
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER