Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-28 @ 9:31 AM
Study NCT ID:
NCT00624702
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2008-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D003371', 'term': 'Cough'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2008-02-15', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)', 'timeFrame': 'throughout the study'}, {'measure': 'Severity of cough: to be judged independently by both the patient and the physician', 'timeFrame': 'throughout the study'}, {'measure': 'Occurrence of cough within 1 minute post dose', 'timeFrame': 'throughout the study'}, {'measure': 'Number of coughs', 'timeFrame': 'throughout the study'}, {'measure': 'Duration of coughing', 'timeFrame': 'throughout the study'}], 'secondaryOutcomes': [{'measure': 'Presence of cough within 5 minutes post dose and the onset of cough (relative to inhalation)', 'timeFrame': 'throughout the study'}, {'measure': 'Severity of cough: to be judged independently by both the patient and the physician', 'timeFrame': 'throughout the study'}, {'measure': 'Occurrence of cough within 1 minute post dose', 'timeFrame': 'throughout the study'}, {'measure': 'Number of coughs', 'timeFrame': 'throughout the study'}, {'measure': 'Duration of coughing', 'timeFrame': 'throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma, cough, spirometry, maleate, xinafoate, acetate, SDDPI (single dose dry powder inhaler)'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3022', 'label': 'Results for QAB149B2102 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This study will explore information on whether changing the salt formulation of indacaterol affects the incidence of post-inhalation cough.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients 18 to 65 years old (inclusive)\n* Patients with mild to moderate persistent asthma\n* BMI must be within the range of 18-32 kg/m2 inclusive\n* Female subjects must:\n\n 1. have been sterilized at least 6 months prior to screening\n 2. be post-menopausal with no regular bleeding for at least a year prior to inclusion\n\nExclusion Criteria:\n\n* Patients with life-threatening arrhythmias\n* Patients with COPD or diabetes mellitus\n* History of immunocompromise, including a positive HIV\n* A positive Hepatitis B surface antigen (HBsAg) of Hepatitis C test result\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00624702', 'briefTitle': 'Tolerability of Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Randomized, Single-dose, Double-blind, 4-way Cross-over Study to Evaluate Tolerability Following Treatment With Indacaterol Salts (Maleate, Xinafoate and Acetate) in Comparison to Placebo in Patients With Mild to Moderate Persistent Asthma', 'orgStudyIdInfo': {'id': 'CQAB149B2102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Active Comparator 1 different salt formulation of Indacaterol.', 'interventionNames': ['Drug: Indacaterol maleate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Active Comparator 2 different salt formulation of Indacaterol.', 'interventionNames': ['Drug: Indacaterol maleate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Active Comparator 3 different salt formulation of Indacaterol.', 'interventionNames': ['Drug: Indacaterol maleate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Indacaterol maleate', 'type': 'DRUG', 'description': 'Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval', 'armGroupLabels': ['1']}, {'name': 'Indacaterol maleate', 'type': 'DRUG', 'description': 'Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval', 'armGroupLabels': ['2']}, {'name': 'Indacaterol maleate', 'type': 'DRUG', 'description': 'Four single dose treatments (each dose is 400 µg-for the active salts-via SDDPI), with at least a 7 day inter-dose interval', 'armGroupLabels': ['3']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigator Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis investigator site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Novartis', 'oldOrganization': 'Novartis'}}}}