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Longitudinal Cohort Study in Participants With Severe Asthma to Assess Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537691
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
Prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.

Condition or disease Intervention/treatment Phase
Asthma Drug: FP Drug: LABA Drug: LTRA Drug: LAMA Drug: Theophylline Drug: Oral Corticosteroids Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Prospective, Single Arm, Longitudinal Cohort Study To Assess Biomarkers In Real World Patients With Severe Asthma
Actual Study Start Date : August 28, 2015
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : July 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Inhaled Corticosteroids (ICS) + Controller Medications
Participants with severe asthma Global Initiative for Asthma (GINA) step 4/5 as indicated by current treatment with daily ICS consisting of >/=500 mcg FP administered by DPI (or equivalent), and at least one of the following controller medications: LABAs, LTRAs, LAMAs, theophylline or oral corticosteroids.
Drug: FP
ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.

Drug: LABA
LABA will be administered as per investigator discretion.

Drug: LTRA
LTRA will be administered as per investigator discretion.

Drug: LAMA
LAMA will be administered as per investigator discretion.

Drug: Theophylline
Theophylline will be administered as per investigator discretion.

Drug: Oral Corticosteroids
Oral corticosteroids will be administered as per investigator discretion.




Primary Outcome Measures :
  1. Mean Number of Asthma Exacerbations in Participants With High Baseline Periostin Compared to participants With Low Baseline Periostin [ Time Frame: Baseline up to Week 52 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Asthma Exacerbations [ Time Frame: Baseline up to Week 52 ]
  2. Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Specified Time Points [ Time Frame: Baseline, Weeks 26, 52 ]
  3. Time Taken for the Occurrence of First Asthma Exacerbation [ Time Frame: Baseline up to Week 52 ]
  4. Time to Treatment Failure [ Time Frame: Baseline up to Week 52 ]
  5. Change From Baseline in Mini Standardized Asthma Quality of Life Questionnaire (MiniAQLQ) at Specified Time Points [ Time Frame: Baseline, Weeks 13, 26, 39, 52 ]
  6. Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) at Specified Time Points [ Time Frame: Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52) ]
  7. Change From Baseline in Asthma Control Test (ACT) at Specified Time Points [ Time Frame: Baseline, Weeks 13, 26, 39, 52 or within 12 weeks of last visit for early termination (up to Week 52) ]
  8. Percentage of Participants With Changes to Standard of Care (SoC) Asthma Treatment as Reported by the Investigator and Confirmed by Study Steering Committee [ Time Frame: Baseline up to Week 52 ]
  9. Serum Periostin Levels During the Study [ Time Frame: Baseline, Weeks 26, 52 ]
  10. Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels [ Time Frame: Baseline, Weeks 26, 52 ]
  11. Blood Eosinophil Levels During the Study [ Time Frame: Baseline, Weeks 26, 52 ]
  12. Serum Immunoglobulin E (IgE) Levels During the Study [ Time Frame: Baseline, Weeks 26, 52 ]
  13. Number of Urgent Asthma-Related Health Care Utilization: Hospitalizations [ Time Frame: Weeks 13, 26, 39, 52 ]
  14. Number of Urgent Asthma-Related Health Care Utilization: Emergency Department Visits [ Time Frame: Weeks 13, 26, 39, 52 ]
  15. Number of Urgent Asthma-Related Health Care Utilization: Acute Care Visits [ Time Frame: Weeks 13, 26, 39, 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma diagnosed by a respiratory physician greater than or equal to (>/=) 12 months prior to study enrolment
  • Pre-bronchodilator FEV1 of 30 percent (%) to 85% at baseline/Visit 1
  • Documented bronchodilator response defined as >/=12% relative improvement in FEV1 after bronchodilator administration or a positive methacholine bronchial challenge test with provocative concentration causing a 20% fall in FEV1 (PC20) less than (<) 8 milligrams (mg) at study baseline/Visit 1 or within 24 months prior to baseline
  • Current treatment with a total daily dose of >/= 500 micrograms (mcg) of fluticasone propionate (FP) dry powder inhaler (DPI) (or equivalent ) and at least one of the following controller medications: long-acting Beta-agonist (LABA), leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonists (LAMAs), theophylline or oral corticosteroids, with a continued duration of three months prior to baseline/Visit 1

Exclusion Criteria:

  • Acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently require, hospitalization or antimicrobial treatment during the last four weeks prior to participant eligibility
  • Acute asthma exacerbation or any other medical event treated with increased doses of oral, or any dose of intramuscular (IM) or intravenous (IV) corticosteroids within six weeks prior to study
  • Other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to baseline/Visit 1
  • Ex-smokers with >/=10 pack-year smoking history
  • Prior treatment with bronchial thermoplasty
  • Participation in any clinical trial of an investigational agent or procedure within six months prior to baseline/Visit 1 or during the study
  • Pregnancy prior to participation or during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537691


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02537691    
Other Study ID Numbers: MB29599
2015-000742-35 ( EudraCT Number )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents