Asthma
Conditions
Brief summary
Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.
Interventions
DRUGmontelukast sodium
montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage * Peak expiratory flow is \> or = 80% of predicted value on the day of visit 1 * Uncontrolled as per Canadian asthma consensus guidelines
Exclusion criteria
* Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms * Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control | 8 weeks (from Week 0 to Week 8) | Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered yes to at least 2 of the 8 asthma control parameters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score | 8 weeks (from Week 0 to Week 8) | Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score |
| Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ) | 8 weeks (from Week 0 to Week 8) | The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Global Satisfaction | 8 weeks (from Week 0 to Week 8) | At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication. |
| Physician Global Satisfaction | 8 weeks (from Week 0 to Week 8) | At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication. |
| Patient Global Allergic Rhinitis Symptoms Assessment | 8 weeks (from Week 0 to Week 8) | At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms. |
Participant flow
Recruitment details
First 25 asthmatic patients seen consecutively at each site were invited to participate. Treatment phase: From the Survey population, blocks of 8 were allowed to participate. All subjects took 1 tablet of montelukast 10 mg once a day at bedtime. First patient in: APR-02-2007 Last patient out: JAN-25-2008
Pre-assignment details
The anticipated Enrollment was 440, with an expected rate of 20% over the 8-week period, thus 369 patients should complete the study.
Participants by arm
| Arm | Count |
|---|---|
| All Patients montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment
Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients. | 313 |
| Total | 313 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 46.1 years STANDARD_DEVIATION 17.2 |
| Allergic Rhinitis Diagnosis Duration | 131.4 Months STANDARD_DEVIATION 135.4 |
| Asthma Diagnosis Duration | 147.6 Months STANDARD_DEVIATION 139 |
| Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist Use Inhaled Corticosteroids/Long-Acting Beta 2-Agonist | 153 participants |
| Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist Use Inhaled Corticosteroids Only | 154 participants |
| Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist Use Missing | 6 participants |
| Sex: Female, Male Female | 199 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 313 |
| serious Total, serious adverse events | 0 / 313 |
Outcome results
Primary
Asthma Control
Asthma control was assessed by the Canadian Asthma Consensus Guidelines at week 0 and week 8. Patients were considered uncontrolled if they answered yes to at least 2 of the 8 asthma control parameters.
Time frame: 8 weeks (from Week 0 to Week 8)
Population: 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase (All Patients) Week 0 | Asthma Control | Uncontrolled | 312 Participants |
| Treatment Phase (All Patients) Week 0 | Asthma Control | Controlled | 0 Participants |
| Treatment Phase (All Patients) Week 0 | Asthma Control | Missing | 1 Participants |
| Treatment Phase (All Patients) Week 8 | Asthma Control | Uncontrolled | 72 Participants |
| Treatment Phase (All Patients) Week 8 | Asthma Control | Controlled | 229 Participants |
| Treatment Phase (All Patients) Week 8 | Asthma Control | Missing | 0 Participants |
Secondary
Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ)
The Asthma Control Questionnaire consists of 7 specific questions that were used to assess patient asthma control at week 0 and week 8. The mean score per question is used to determine the level of control, with a final score ranging from 0 (well-controlled) to 6 (extremely poorly controlled) units on a scale.
Time frame: 8 weeks (from Week 0 to Week 8)
Population: There were 313 patients who qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit; of these, 300 patients completed the ACQ at week 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Phase (All Patients) Week 0 | Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ) | 2.03 Units on a Scale | Standard Deviation 0.8 |
| Treatment Phase (All Patients) Week 8 | Effectiveness of Montelukast Therapy Used in Combination With Inhaled Corticosteroids or Inhaled Corticosteroids / Long-Acting Beta 2-Agonist in Improving the Symptoms of Asthma Using the Asthma Control Questionnaire (ACQ) | 0.92 Units on a Scale | Standard Deviation 0.8 |
p-value: <0.001t-test, 2 sided
Secondary
The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score
Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) consists of 14 questions to assess patient's overall quality of life related to allergic rhinitis on a scale of 0 (least impairment) to 6 (greatest impairment). The score is the mean of the 14 questions, ranging from 0 to 6. Change is computed as Week 8 score - Week 0 score
Time frame: 8 weeks (from Week 0 to Week 8)
Population: Based on ITT population; there were 286 patients with available data regarding the mean change in MiniRQLQ at week 8.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Phase (All Patients) Week 0 | The Mean Change in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) Overall Score | -1.45 Units on a Scale | Standard Deviation 1.35 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Patient Global Allergic Rhinitis Symptoms Assessment
At week 0 and week 8, patients were asked to complete one question describing their perception of their allergic rhinitis symptoms.
Time frame: 8 weeks (from Week 0 to Week 8)
Population: 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase (All Patients) Week 0 | Patient Global Allergic Rhinitis Symptoms Assessment | Not really bothersome | 35 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Allergic Rhinitis Symptoms Assessment | Bothersome some of the time | 91 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Allergic Rhinitis Symptoms Assessment | A non-issue as I do not have these symptoms | 11 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Allergic Rhinitis Symptoms Assessment | Bothersome a good bit of the time | 94 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Allergic Rhinitis Symptoms Assessment | Missing | 9 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Allergic Rhinitis Symptoms Assessment | Bothersome a little of the time | 73 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Allergic Rhinitis Symptoms Assessment | Missing | 1 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Allergic Rhinitis Symptoms Assessment | A non-issue as I do not have these symptoms | 41 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Allergic Rhinitis Symptoms Assessment | Not really bothersome | 129 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Allergic Rhinitis Symptoms Assessment | Bothersome a little of the time | 77 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Allergic Rhinitis Symptoms Assessment | Bothersome some of the time | 40 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Allergic Rhinitis Symptoms Assessment | Bothersome a good bit of the time | 13 Participants |
Comparison: McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)p-value: <0.001McNemar-Bowker
Other Pre-specified
Patient Global Satisfaction
At week 0 and week 8, patients were asked to complete a single question describing how satisfied they were regarding their asthma controller medication.
Time frame: 8 weeks (from Week 0 to Week 8)
Population: 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase (All Patients) Week 0 | Patient Global Satisfaction | Very satisfied | 24 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Satisfaction | Satisfied | 77 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Satisfaction | Neither satisfied or dissatisfied | 104 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Satisfaction | Dissatisfied | 97 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Satisfaction | Very dissatisfied | 11 Participants |
| Treatment Phase (All Patients) Week 0 | Patient Global Satisfaction | Missing | 0 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Satisfaction | Very dissatisfied | 1 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Satisfaction | Very satisfied | 136 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Satisfaction | Dissatisfied | 16 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Satisfaction | Satisfied | 110 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Satisfaction | Missing | 2 Participants |
| Treatment Phase (All Patients) Week 8 | Patient Global Satisfaction | Neither satisfied or dissatisfied | 36 Participants |
Comparison: McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)p-value: <0.001McNemar-Bowker
Other Pre-specified
Physician Global Satisfaction
At week 0 and week 8, physicians were asked to complete a single question describing how satisfied they were regarding their patient's asthma controller medication.
Time frame: 8 weeks (from Week 0 to Week 8)
Population: 319 patients advanced to the treatment phase and 313 patients qualified for inclusion in the intent to treat (ITT) analysis and completed the first visit. The following results are based on the 301 patients who completed week 8.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase (All Patients) Week 0 | Physician Global Satisfaction | Satisfied | 54 Participants |
| Treatment Phase (All Patients) Week 0 | Physician Global Satisfaction | Dissatisfied | 142 Participants |
| Treatment Phase (All Patients) Week 0 | Physician Global Satisfaction | Very satisfied | 7 Participants |
| Treatment Phase (All Patients) Week 0 | Physician Global Satisfaction | Very dissatisfied | 4 Participants |
| Treatment Phase (All Patients) Week 0 | Physician Global Satisfaction | Neither satisfied or dissatisfied | 104 Participants |
| Treatment Phase (All Patients) Week 0 | Physician Global Satisfaction | Missing | 2 Participants |
| Treatment Phase (All Patients) Week 8 | Physician Global Satisfaction | Neither satisfied or dissatisfied | 30 Participants |
| Treatment Phase (All Patients) Week 8 | Physician Global Satisfaction | Very satisfied | 135 Participants |
| Treatment Phase (All Patients) Week 8 | Physician Global Satisfaction | Satisfied | 110 Participants |
| Treatment Phase (All Patients) Week 8 | Physician Global Satisfaction | Missing | 0 Participants |
| Treatment Phase (All Patients) Week 8 | Physician Global Satisfaction | Dissatisfied | 25 Participants |
| Treatment Phase (All Patients) Week 8 | Physician Global Satisfaction | Very dissatisfied | 1 Participants |
Comparison: McNemar-Bowker test is McNemar chi-squared statistic for binary matched pairs, with Bowker chi-squared fit test of symmetry model (tests all rows of data) (cf. Agresti, 2007)p-value: <0.001McNemar-Bowker