Asthma
Conditions
Brief summary
a study to describe patient and physician satisfaction with montelukast therapy for the control of asthma used either as monotherapy or in combination with inhaled corticosteroids
Interventions
DRUGmontelukast sodium
Montelukast 4-5 mg for 12 weeks, oral tablet
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Patient Is Diagnosed With Asthma For At Least 6 Months * Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10) * Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage * Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks
Exclusion criteria
* As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort) * Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Questionnaire (ACQ) | Week 0, 4, and 12 | ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Questionnaire (ACQ) | Week 0, 4, and 12 | ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physician Global Satisfaction | week 0, 4, 8 and 12 | At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients. |
| Patient Global Satisfaction | Week 0, 4, 8 and 12 | At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication. |
| Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | Weeks 4, 8, and 12 | The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described. |
Participant flow
Recruitment details
First patient in: JUN-19-2006 Last patient out: OCT-28-2008 Total number of sites: 37 sites in Canada
Participants by arm
| Arm | Count |
|---|---|
| Montelukast Montelukast 4-5 mg for 12 weeks, oral tablet | 420 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 13 |
| Overall Study | Lost to Follow-up | 26 |
| Overall Study | No improvement | 3 |
| Overall Study | Parent dissatisfied | 1 |
| Overall Study | Parent misunderstood study | 1 |
| Overall Study | Patient moved | 1 |
| Overall Study | Protocol Violation | 4 |
| Overall Study | Screening Failure | 2 |
| Overall Study | Stopped Medication | 4 |
| Overall Study | Withdrawal by Subject | 17 |
Baseline characteristics
| Characteristic | Montelukast |
|---|---|
| Age, Continuous | 7.00 years STANDARD_DEVIATION 3.33 |
| Asthma Diagnosis Duration | 45.58 Months STANDARD_DEVIATION 34.72 |
| ICS (Inhaled Corticosteroids) Use No Use | 97 Participants |
| ICS (Inhaled Corticosteroids) Use Use | 323 Participants |
| Sex: Female, Male Female | 168 Participants |
| Sex: Female, Male Male | 252 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 146 / — |
| serious Total, serious adverse events | 5 / — |
Outcome results
Primary
Asthma Control Questionnaire (ACQ)
ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.
Time frame: Week 0, 4, and 12
Population: 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4 and the 373 patients who completed week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast ITT at Week 0 | Asthma Control Questionnaire (ACQ) | Missing | 1 Participants |
| Montelukast ITT at Week 0 | Asthma Control Questionnaire (ACQ) | Well controlled | 91 Participants |
| Montelukast ITT at Week 0 | Asthma Control Questionnaire (ACQ) | Not well controlled | 328 Participants |
| Montelukast ITT at Week 4 | Asthma Control Questionnaire (ACQ) | Missing | 1 Participants |
| Montelukast ITT at Week 4 | Asthma Control Questionnaire (ACQ) | Not well controlled | 159 Participants |
| Montelukast ITT at Week 4 | Asthma Control Questionnaire (ACQ) | Well controlled | 251 Participants |
| Montelukast ITT at Week 12 | Asthma Control Questionnaire (ACQ) | Well controlled | 276 Participants |
| Montelukast ITT at Week 12 | Asthma Control Questionnaire (ACQ) | Not well controlled | 96 Participants |
| Montelukast ITT at Week 12 | Asthma Control Questionnaire (ACQ) | Missing | 1 Participants |
p-value: <0.001McNemar
p-value: <0.001McNemar
Secondary
Asthma Control Questionnaire (ACQ)
ACQ is a questionnaire consisting of seven 7-point Likert scale questions describing frequency and severity of asthma symptoms. Score ranges between 0 (well-controlled) and 6 (extremely poorly controlled); a score of ≤0.75 indicates well controlled symptoms.
Time frame: Week 0, 4, and 12
Population: 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast ITT at Week 0 | Asthma Control Questionnaire (ACQ) | Not tapered and Not well controlled | 144 Participants |
| Montelukast ITT at Week 0 | Asthma Control Questionnaire (ACQ) | Not tapered and Well controlled | 208 Participants |
| Montelukast ITT at Week 0 | Asthma Control Questionnaire (ACQ) | Tapered and Not well controlled | 15 Participants |
| Montelukast ITT at Week 0 | Asthma Control Questionnaire (ACQ) | Tapered and Well controlled | 43 Participants |
| Montelukast ITT at Week 0 | Asthma Control Questionnaire (ACQ) | Missing | 1 Participants |
| Montelukast ITT at Week 4 | Asthma Control Questionnaire (ACQ) | Not tapered and Well controlled | 121 Participants |
| Montelukast ITT at Week 4 | Asthma Control Questionnaire (ACQ) | Not tapered and Not well controlled | 60 Participants |
| Montelukast ITT at Week 4 | Asthma Control Questionnaire (ACQ) | Missing | 0 Participants |
| Montelukast ITT at Week 4 | Asthma Control Questionnaire (ACQ) | Tapered and Well controlled | 52 Participants |
| Montelukast ITT at Week 4 | Asthma Control Questionnaire (ACQ) | Tapered and Not well controlled | 14 Participants |
| Montelukast ITT at Week 12 | Asthma Control Questionnaire (ACQ) | Not tapered and Not well controlled | 82 Participants |
| Montelukast ITT at Week 12 | Asthma Control Questionnaire (ACQ) | Not tapered and Well controlled | 216 Participants |
| Montelukast ITT at Week 12 | Asthma Control Questionnaire (ACQ) | Tapered and Not well controlled | 14 Participants |
| Montelukast ITT at Week 12 | Asthma Control Questionnaire (ACQ) | Missing | 1 Participants |
| Montelukast ITT at Week 12 | Asthma Control Questionnaire (ACQ) | Tapered and Well controlled | 60 Participants |
Other Pre-specified
Patient Global Satisfaction
At week 0, 4, 8 and 12, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.
Time frame: Week 0, 4, 8 and 12
Population: 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast ITT at Week 0 | Patient Global Satisfaction | Very Satisfied | 11 Participants |
| Montelukast ITT at Week 0 | Patient Global Satisfaction | Satisfied | 62 Participants |
| Montelukast ITT at Week 0 | Patient Global Satisfaction | Missing | 2 Participants |
| Montelukast ITT at Week 0 | Patient Global Satisfaction | Neither Satisfied or Dissatisfied | 137 Participants |
| Montelukast ITT at Week 0 | Patient Global Satisfaction | Very Dissatisfied | 18 Participants |
| Montelukast ITT at Week 0 | Patient Global Satisfaction | Dissatisfied | 190 Participants |
| Montelukast ITT at Week 4 | Patient Global Satisfaction | Neither Satisfied or Dissatisfied | 74 Participants |
| Montelukast ITT at Week 4 | Patient Global Satisfaction | Missing | 2 Participants |
| Montelukast ITT at Week 4 | Patient Global Satisfaction | Very Satisfied | 145 Participants |
| Montelukast ITT at Week 4 | Patient Global Satisfaction | Satisfied | 161 Participants |
| Montelukast ITT at Week 4 | Patient Global Satisfaction | Dissatisfied | 26 Participants |
| Montelukast ITT at Week 4 | Patient Global Satisfaction | Very Dissatisfied | 3 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Very Satisfied | 129 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Neither Satisfied or Dissatisfied | 24 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Dissatisfied | 6 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Missing | 1 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Very Dissatisfied | 0 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Satisfied | 87 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Dissatisfied | 7 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Satisfied | 120 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Neither Satisfied or Dissatisfied | 48 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Missing | 2 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Very Dissatisfied | 2 Participants |
| Montelukast ITT at Week 12 | Patient Global Satisfaction | Very Satisfied | 194 Participants |
p-value: <0.001McNemar-Bowker
Other Pre-specified
Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)
The change in the quality of life of the caregivers of patients treated with montelukast for the control of asthma used in combination with inhaled corticosteroids, using the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). PACQLQ score ranges between 1 (severe impairment) and 7 (no impairment) where a higher score indicates better quality of life. An average change in overall score ≥0.7 is considered clinically significant. Changes between visits and baseline are described.
Time frame: Weeks 4, 8, and 12
Population: 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Montelukast ITT at Week 0 | Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | 1.06 Units on a Scale | Standard Deviation 1.27 |
| Montelukast ITT at Week 4 | Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | 1.39 Units on a Scale | Standard Deviation 1.39 |
| Montelukast ITT at Week 12 | Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) | 1.36 Units on a Scale | Standard Deviation 1.34 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Physician Global Satisfaction
At week 0, 4, 8 and 12, physicians were asked to complete a single question describing how satisfied they were regarding the asthma controller medication for each of their enrolled patients.
Time frame: week 0, 4, 8 and 12
Population: 420 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 411 patients who completed week 4, the 247 who completed week 8, and the 373 patients who completed week 12.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Montelukast ITT at Week 0 | Physician Global Satisfaction | Very satisfied | 2 Participants |
| Montelukast ITT at Week 0 | Physician Global Satisfaction | Satisfied | 23 Participants |
| Montelukast ITT at Week 0 | Physician Global Satisfaction | Neither Satisfied or Dissatisfied | 96 Participants |
| Montelukast ITT at Week 0 | Physician Global Satisfaction | Dissatisfied | 266 Participants |
| Montelukast ITT at Week 0 | Physician Global Satisfaction | Very Dissatisfied | 26 Participants |
| Montelukast ITT at Week 0 | Physician Global Satisfaction | Missing | 7 Participants |
| Montelukast ITT at Week 4 | Physician Global Satisfaction | Missing | 3 Participants |
| Montelukast ITT at Week 4 | Physician Global Satisfaction | Dissatisfied | 28 Participants |
| Montelukast ITT at Week 4 | Physician Global Satisfaction | Very satisfied | 130 Participants |
| Montelukast ITT at Week 4 | Physician Global Satisfaction | Neither Satisfied or Dissatisfied | 101 Participants |
| Montelukast ITT at Week 4 | Physician Global Satisfaction | Satisfied | 148 Participants |
| Montelukast ITT at Week 4 | Physician Global Satisfaction | Very Dissatisfied | 1 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Satisfied | 100 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Neither Satisfied or Dissatisfied | 22 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Dissatisfied | 7 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Missing | 2 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Very Dissatisfied | 0 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Very satisfied | 116 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Very Dissatisfied | 3 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Missing | 2 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Satisfied | 136 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Dissatisfied | 14 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Very satisfied | 186 Participants |
| Montelukast ITT at Week 12 | Physician Global Satisfaction | Neither Satisfied or Dissatisfied | 32 Participants |
p-value: <0.001McNemar-Bowker
p-value: <0.001McNemar-Bowker