Allergic RhinitisPhase 4NCT02551536
Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis
A Phase 4 study testing Montelukast, Fexofenadine and Levocetrizine in people with Allergic Rhinitis, run by Indira Gandhi Medical College, Shimla.
Trial summary
Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, intranasal corticosteroids are the pillars in the management of AR.Materials and methods: Seventy patients with allergic… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Montelukast, Fexofenadine and Levocetrizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- either gender having moderate-severe intermittent or mild persistent allergic rhinitis according to original Aria classification.
- subjects with Total Nasal Symptom Score (TNSS) of 5 or higher.
- not treated with antihistaminics in previous week.
- Patients willing to sign written informed consent
- free of any clinically significant disease
- having normal E.C.G
Who cannot join
- participation of children, pregnant female, nursing mothers,
- patients with asthma requiring chronic use of inhaled or systemic corticosteroids
- history of failure to improve symptoms with antihistaminic drug treatment in the past 4.history of allergies to study medication or tolerance to antihistamines, 5.use of study drug in the last 7 days. 6. subjects with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease
About this study
Official title: Comparison of Efficacy, Safety and Cost Effectiveness of Montelukast and Levocetirizine Versus Montelukast and Fexofenadine in Patients of Allergic Rhinitis: a Randomized, Double-blind Clinical Trial
Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, intranasal corticosteroids are the pillars in the management of AR.Materials and methods: Seventy patients with allergic rhinitis participated in a prospective, randomized, double-blind, parallel, active controlled, comparative 4 week trial. The patients between age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent allergic rhinitis were included. The study inclusion criteria required the subjects with Total Nasal Symptom Score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetrizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter.
Read the detailed description
Allergic Rhinitis (AR) is a global health problem. It is the cause of major illness and disability worldwide. Estimates indicate that 10-25% of population worldwide is affected by AR. The main symptoms of AR include nasal congestion, rhinorrhea, itching, sneezing and non-nasal symptoms like burning, itching and watery eyes or itching ears and palate. These symptoms can have a considerable toll on patient's quality of life by interfering with cognitive and emotional functioning. The estimated annual cost attributable to AR in United States ranges from $1.4 billion to nearly $ 6 billion in direct cost annually. Today's antiallergic therapy is based on avoidance of the causative allergen, symptomatic pharmacotherapy, specific immunotherapy and education. Oral/intranasal H1-antihistaminics, decongestants, leukotrienes receptor antagonists, intranasal corticosteroids are the pillars in the management of allergic rhinitis. Second generation antihistamines have become increasingly popular because of their comparable efficacy and lower incidence of adverse effects relative to first generation counterparts. Levocetirizine, a potent second generation histamine (H1) receptor antagonist, is effective against persistent allergic rhinitis and thus improves quality of life and reduces co-morbidities and societal costs. Fexofenadine, is a selective, non sedating, second generation H1 receptor antagonist which have an additional impact on the inflammatory mediators. Monteleukast is a highly selective type I receptor antagonist of leukotriene D4. The leukotrienes modifiers have both anti-inflammatory and bronchodilator properties.
The literature search establishes that addition of an antihistamine to montelukast has added benefit. The combination therapy of montelukast with antihistamine provide enhancing and complimentary effects thereby reducing the symptoms effectively. The results with concomitant levocetirizine and montelukast treatment are better as compared to monotherapy with levocetirizine on symptoms and quality of life in allergic rhinitis. Fexofenadine along with montelukast is more effective than antihistaminic alone in control of allergic rhinitis symptoms. There is literature available for the comparisons of concomitant levocetirizine and montelukast with monotherapy or placebo and comparisons of concomitant fexofenadine and montelukast with monotherapy or placebo. But scanty data is available regarding comparisons of concomitant montelukast-levocetirizine with montelukast-fexofenadine.
- Conditions
- Allergic Rhinitis
- Being tested
- Montelukast, Fexofenadine, Levocetrizine
- Keywords
- Allergic rhinitis, montelukast, fexofenadine, levocetrizine
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
FexofenadineDrug
group B received FDC tablet of montelukast 10mg and fexofenadine 120 mg O.D
LevocetrizineDrug
group A recieved FDC tablet of montelukast 10 mg and levocetrizine 5mg O.D
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | FDC tablet of montelukast 10 mg and levocetrizine 5 mg was given once daily for 4 weeks Receives: Drug: Montelukast; Drug: Levocetrizine |
| Group B | Experimental | FDC tablet of montelukast 10 mg and fexofenadine 120 mg was given once daily for 4 weeks Receives: Drug: Montelukast; Drug: Fexofenadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score (TNSS)
The TNSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).
Measured: 4 week
adverse drug reaction
General clinical safety was monitored by vigilant follow-up of patients for the treatment of emergent adverse events if any, and recorded in the case report form
Measured: 4 week
Secondary outcomes (1)
cost effectiveness ratio
direct cost parameters were taken into consideration. Direct cost parameters were cost of medications used, medical procedures and hospitalization charges, if any. Cost-effectiveness ratio of both treatment groups were calculated based on formula as given below.
Cost-effectiveness ratio = cost / outcome Outcome was measured in terms of effectiveness. TNSS parameter was the main effectiveness parameter.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indira Gandhi Medical College, Shimla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.MOHINI MAHATME, Indira Gandhi Medical College, Shimla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551536
- Sponsor's protocol ID
- IEC/425-26/13
- Status last verified
- Sep 2015
- First submitted
- 12 Aug 2015
- Last updated
- 16 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy, Safety and Cost Effectiveness of Montelukast and Levocetirizine Versus Montelukast and Fexofenadine in Patients of Allergic Rhinitis: a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02551536
- Acronym / sponsor ID
- IEC/425-26/13
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic rhinitis, montelukast, fexofenadine, levocetrizine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Indira Gandhi Medical College, ShimlaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population worldwide is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor antagonists, intranasal corticosteroids are the pillars in the management of AR.Materials and methods: Seventy patients with allergic rhinitis participated in a prospective, randomized, double-blind, parallel, active controlled, comparative 4 week trial. The patients between age group of 18-65 years of either gender having moderate-severe intermittent or mild persistent allergic rhinitis were included. The study inclusion criteria required the subjects with Total Nasal Symptom Score (TNSS) of 5 or higher. The patients were randomly divided into two treatment groups with montelukast-levocetrizine (10 mg and 5 mg) in one group and montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main effectiveness parameter.
Detailed description
Allergic Rhinitis (AR) is a global health problem. It is the cause of major illness and disability worldwide. Estimates indicate that 10-25% of population worldwide is affected by AR. The main symptoms of AR include nasal congestion, rhinorrhea, itching, sneezing and non-nasal symptoms like burning, itching and watery eyes or itching ears and palate. These symptoms can have a considerable toll on patient's quality of life by interfering with cognitive and emotional functioning. The estimated annual cost attributable to AR in United States ranges from $1.4 billion to nearly $ 6 billion in direct cost annually. Today's antiallergic therapy is based on avoidance of the causative allergen, symptomatic pharmacotherapy, specific immunotherapy and education. Oral/intranasal H1-antihistaminics, decongestants, leukotrienes receptor antagonists, intranasal corticosteroids are the pillars in the management of allergic rhinitis. Second generation antihistamines have become increasingly popular because of their comparable efficacy and lower incidence of adverse effects relative to first generation counterparts. Levocetirizine, a potent second generation histamine (H1) receptor antagonist, is effective against persistent allergic rhinitis and thus improves quality of life and reduces co-morbidities and societal costs. Fexofenadine, is a selective, non sedating, second generation H1 receptor antagonist which have an additional impact on the inflammatory mediators. Monteleukast is a highly selective type I receptor antagonist of leukotriene D4. The leukotrienes modifiers have both anti-inflammatory and bronchodilator properties.
The literature search establishes that addition of an antihistamine to montelukast has added benefit. The combination therapy of montelukast with antihistamine provide enhancing and complimentary effects thereby reducing the symptoms effectively. The results with concomitant levocetirizine and montelukast treatment are better as compared to monotherapy with levocetirizine on symptoms and quality of life in allergic rhinitis. Fexofenadine along with montelukast is more effective than antihistaminic alone in control of allergic rhinitis symptoms. There is literature available for the comparisons of concomitant levocetirizine and montelukast with monotherapy or placebo and comparisons of concomitant fexofenadine and montelukast with monotherapy or placebo. But scanty data is available regarding comparisons of concomitant montelukast-levocetirizine with montelukast-fexofenadine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Montelukast, Drug: LevocetrizineFDC tablet of montelukast 10 mg and levocetrizine 5 mg was given once daily for 4 weeks |
| Group B | Experimental | Drug: Montelukast, Drug: FexofenadineFDC tablet of montelukast 10 mg and fexofenadine 120 mg was given once daily for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- either gender having moderate-severe intermittent or mild persistent allergic rhinitis according to original Aria classification.
- subjects with Total Nasal Symptom Score (TNSS) of 5 or higher.
- not treated with antihistaminics in previous week.
- Patients willing to sign written informed consent
- free of any clinically significant disease
Key exclusion criteria (3 listed)
- participation of children, pregnant female, nursing mothers,
- patients with asthma requiring chronic use of inhaled or systemic corticosteroids
- history of failure to improve symptoms with antihistaminic drug treatment in the past 4.history of allergies to study medication or tolerance to antihistamines, 5.use of study drug in the last 7 days. 6. subjects with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease
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 | Drug | Group A, Group B |
| Fexofenadinegroup B received FDC tablet of montelukast 10mg and fexofenadine 120 mg O.D | Drug | Group B |
| Levocetrizinegroup A recieved FDC tablet of montelukast 10 mg and levocetrizine 5mg O.D | Drug | Group A |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: 4 week
The TNSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).
adverse drug reaction
Time frame: 4 week
General clinical safety was monitored by vigilant follow-up of patients for the treatment of emergent adverse events if any, and recorded in the case report form
1 secondary outcome
cost effectiveness ratio
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Montelukast, Fexofenadine and Levocetrizine in people with Allergic Rhinitis, run by Indira Gandhi Medical College, Shimla.
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 6 inclusion and 3 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 16 Sep 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Nasal Symptom Score (TNSS) (time frame: 4 week). 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?
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 16 Sep 2015.