Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2026-02-28 @ 10:02 PM
Study NCT ID:
NCT03096327
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2017-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'To ensure double-blind allocation, the sponsor, who is not directly involved in clinical team will use a random number sequence generated by a computer software to allocate the participant to either the treatment or placebo group. Patients who will be randomized to the treatment group will receive 10 mg montelukast. Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured.\n\nBoth products will be packaged in identical plastic bottles identifiable only by the patient allocation number. Patient will be asked to take one montelukast each day. Acceptable compliance will be defined as at least taking medication at least 21 days. The patients will be instructed to leave the remaining tablets in bottle so that they would be counted later.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Two arm Parallel Assignment Masking: Double Blind Primary Purpose: Prevention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-06', 'studyFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2017-03-23', 'lastUpdatePostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the change in quality of Life using AQLQ (s) questionnaire after 4 weeks of Montelukast.', 'timeFrame': '0 days to 4 weeks', 'description': '\\[Designated as safety issue: No\\]'}], 'secondaryOutcomes': [{'measure': 'To assess the change in Control of Asthma using AQLQ (s) questionnaire after 4 weeks of Montelukast.', 'timeFrame': '0 days to 4 weeks', 'description': '\\[Designated as safety issue: No\\]'}, {'measure': 'Proportion of participants experiencing an adverse event (AE)', 'timeFrame': '0 days to 4 weeks', 'description': '\\[Designated as safety issue: Yes\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of Life', 'Asthma control test', 'Montelukast', 'Asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': '• To compare the quality of Life using AQLQ (s) questionnaire after 4 weeks of Montelukast.', 'detailedDescription': '1.1 Background\n\nAsthma is characterized by airway and lung tissue inflammation and airway hyperresponsiveness (AHR) that leads to recurrent symptoms of wheezing, breathlessness, chest tightness, and coughing. AHR indicates an exaggerated response of the airway to nonspecific stimuli, which results in a temporary airflow limitation, leading to airway obstruction. It remains unknown which factors within the airway of an individual trigger reversible airway obstruction and airway narrowing. The airway epithelium is composed of many interacting structural components and inflammatory cells. The number, activation, and secretory component of inflammatory cells in the airway are altered in the disease. In asthma, the number of eosinophils and T lymphocytes is increased in the subepithelial layer.\n\nThe impact of asthma has traditionally been measured in terms of the prevalence of the disease, mortality rates, and levels of healthcare utilisation, particularly hospital admissions. However, the impact of asthma extends beyond these outcomes to include effects on lifestyle, wellbeing, and perceived health status. Adults of working age with asthma have poorer health status and quality of life outcomes than those with no asthma. This effect is independent of confounding by sociodemographic and life style factors and is evident across a range of dimensions of quality of life. In comparison with two other chronic health conditions, asthma has a larger adverse impact on health status and quality of life than diabetes.\n\n1.2. Investigational Agent\n\nMontelukast reversibly inhibits cysteinyl leukotrienes (CysLTs), specifically leukotrienes D4 (LTD4 \\[3\\]. LTD4 is the most potent bronchoconstricting agent on a molar basis, but Cys-LTs also have chemoattractive properties for many inflammatory cells (mainly eosinophils), effects on vascular permeability, mucous secretions and sensory nerve activation, and are responsible for part of the pathophysiology of asthma.\n\n1.3. Dose Rational/Risk \\& Benefit\n\nMontelukast is a potent and selective blocker of the CysLT1 receptor. For treatment of chronic asthma, montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form. Given their efficacy, antiinflammatory activity, oral administration, and safety, leukotriene modifiers will play an important role in the treatment of asthmatic patient. Side effects most commonly reported above placebo included headache, otitis media, upper respiratory infection, and pharyngitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Asthma\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Previous adverse reaction to montelukast or other leukotriene inhibitor;\n* History of hyper-eosinophilic disorder other than atopic disease;\n* Treatment with montelukast within 4 weeks from randomization;\n* Asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks from randomization.'}, 'identificationModule': {'nctId': 'NCT03096327', 'acronym': 'TEAM', 'briefTitle': 'TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmEvo Pvt Ltd'}, 'officialTitle': 'TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)', 'orgStudyIdInfo': {'id': 'PE/PK/TEAM/IIT/2017-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention (Montelukast)', 'description': 'Aireez contains Montelukast which is a potent and selective blocker of the CysLT1 receptor. For treatment of chronic asthma, montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form.', 'interventionNames': ['Drug: Montelukast']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Montelukast', 'type': 'DRUG', 'otherNames': ['TEAM'], 'description': 'Montelukast sodium is a selective blocker of the CysLT1 receptor. For treatment of chronic asthma, montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form.', 'armGroupLabels': ['Intervention (Montelukast)']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['TEAM'], 'description': 'Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75510', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dr. Nadeem Rizvi', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Masood Jawaid, MRCS,FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'PharmEvo Pvt Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmEvo Pvt Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}