Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT00273520
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2006-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TELICAST : Telithromycin in Acute Exacerbations of Asthma
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': 'C106791', 'term': 'telithromycin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2004-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2006-01-06', 'studyFirstSubmitQcDate': '2006-01-06', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's daily diary summary symptom scores/Morning diary PEFR", 'timeFrame': 'During the Study Conduct'}], 'secondaryOutcomes': [{'measure': 'In-clinic pulmonary function tests: Forced expiratory volume in 1 second (FEV1), Percent predicted FEV1, Forced vital capacity (FVC), Forced expiratory flow rate at 25% to 75% of FVC (FEF25-75), PEFR, and percent predicted PEFR', 'timeFrame': 'During the study conduct'}, {'measure': 'Evening diary PEFR, and diary PEFR variability', 'timeFrame': 'During the study conduct'}, {'measure': 'Time to symptom resolution from study entry acute exacerbation of asthma', 'timeFrame': 'During the study conduct'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '16611950', 'type': 'RESULT', 'citation': 'Johnston SL, Blasi F, Black PN, Martin RJ, Farrell DJ, Nieman RB; TELICAST Investigators. The effect of telithromycin in acute exacerbations of asthma. N Engl J Med. 2006 Apr 13;354(15):1589-600. doi: 10.1056/NEJMoa044080.'}]}, 'descriptionModule': {'briefSummary': "Primary Objective:\n\n* The primary objective is to evaluate the clinical efficacy of telithromycin versus placebo as a supplement to the usual standard of care during an acute exacerbation of asthma. Efficacy will be assessed by:\n\n * Changes in the diary card summary symptom score assessed daily for 6 weeks, and\n * Changes in the domiciliary morning Peak Expiratory Flow Rate (PEFR) following oral telithromycin treatment\n\nSecondary Objectives:\n\nThe secondary objectives of the study are:\n\n* To evaluate the microbial activity of telithromycin during an exacerbation of asthma by:\n\n * Assessment of the patient's clinical improvement relative to initial C. pneumoniae or M. pneumoniae status, and\n * Analysis of the quantitative changes from baseline in C. pneumonia or M. pneumoniae by culture and quantitative Polymerase Chain Reaction (PCR).\n* To evaluate the safety of 10 days of oral telithromycin as a supplement to the standard of care for patients with acute exacerbations of asthma\n* To assess additional efficacy endpoints and health outcome evaluations following 10 days of treatment with either oral telithromycin or placebo, with either treatment used as a supplement to the standard of care for patients with acute exacerbations of asthma:\n\n * Changes and daily variability in the PEFR during the 6 weeks of study treatment,\n * Health status at follow-up (6 weeks)\n * Pulmonary function tests:\n\n * Forced Expiratory Volume in 1 second (FEV1)\n * Forced Vital Capacity (FVC)\n * Forced Expiratory Flow Rate (FEF25-75%)\n * Need for additional medications (e.g., inhaled corticosteroids, oral corticosteroids, bronchodilator use),\n * Time to next acute exacerbation of asthma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\nPatients meeting all of the following criteria will be considered for enrollment in the study:\n\n* A documented history of asthma for \\>6 months\n* Presenting within 24 hours of initial medical care in an urgent care clinic, emergency room, or in-patient hospital setting. To qualify for enrollment they must present with the following signs and symptoms of an acute deterioration in asthma control: (reduced PEFR, increased wheeze, and dyspnea, with or without cough).\n* A PEFR less than 80% of predicted normal\n* Females who meet the following conditions:\n\n * postmenopausal for at least 1 year, or\n * surgically incapable of bearing children, or\n * of childbearing potential, and all of the following conditions are met:\n\n * had a normal menstrual flow within 1 month before study entry and\n * has a negative pregnancy test (serum b-subunit human chorionic gonadotropin \\[hCG\\]) immediately before study entry and\n * must agree to abstinence or use of an accepted method of contraception\n\nExclusion criteria\n\nPatients presenting with any of the following will not be included in the study:\n\n* Requiring immediate placement in an Intensive Care Unit\n* Obvious known allergic precipitant for this episode of acute severe asthma (e.g., acute exposure to animal dander)\n* Pneumonia\n* Known long QT syndrome or familial history of long QT syndrome (if no previous electrocardiogram \\[ECG\\] has invalidated this risk factor), or personal history of coronary disease, ventricular arrhythmia, bradycardia \\<50 beats/min, or known uncorrected hypokalemia or magnesemia\n* Known impaired hepatic or renal function\n* Known diagnosis of myasthenia gravis\n* Active or quiescent tuberculosis infections of the respiratory tract\n* Acute exacerbation of chronic bronchitis, chronic obstructive pulmonary disease, cystic fibrosis, or emphysema\n* A history of smoking of 10 pack-years or more\n* Women who are breast feeding or are pregnant, as demonstrated by serum or urine pregnancy tests\n* Suspected or known hypersensitivity to, or suspected serious adverse reaction to the macrolide class of antibiotics\n* A concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) that would make implementation of the protocol or interpretation of the study results difficult\n* A recent (within the previous 3 months) history of alcohol or recreational drug misuse.\n* Immunocompromised patients, including but not limited to:\n\n * patients with known human immunodeficiency virus (HIV) infection and have either had or have an AIDS defining condition (e.g., Kaposi's sarcoma, Pneumocystis carinii pneumonia) or a CD4 + T lymphocyte count of \\<200/mL\n * patients with neutropenia (\\<1500 neutrophils/mm3)\n * patients with metastatic or hematological malignancy\n * splenectomized patients or patients with known hyposplenia or asplenia\n* Planned surgical treatment at any time during the course of the study that would be incompatible with the objectives of this study\n* Other disease conditions or infections that could interfere with the evaluation of study treatment efficacy or safety\n* Oral steroid-dependent asthma\n* Antibiotic use within 30 days prior to enrollment\n* Treated within 2 weeks prior to inclusion with CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, and St. John's Wart\n* Currently receiving medication known to prolong QT interval such as cisapride, pimozide, astemizole and terfenadine, or potent CYP3A4 inhibitors such as antiproteases or ketoconazole.\n* Patients in whom an antibiotic is clearly indicated.\n* Have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow-up phase"}, 'identificationModule': {'nctId': 'NCT00273520', 'briefTitle': 'TELICAST : Telithromycin in Acute Exacerbations of Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Telithromycin 800 mg (Once Daily for 10 Days) as a Supplement to the Standard of Care for Patients With Acute Exacerbations of Asthma', 'orgStudyIdInfo': {'id': 'HMR3647A_3503'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Telithromycin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gilles Perdriset', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}