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Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing (INSTAR)

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ClinicalTrials.gov Identifier: NCT03889743
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Turku University Hospital
Karolinska University Hospital
Haukeland University Hospital
University Hospital, Akershus
Helse Stavanger HF
University Hospital of North Norway
Ullevaal University Hospital
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:

The overall objective of the study is to determine the efficacy of corticosteroids in preventing recurrent wheezing and asthma in high-risk, first-time severe wheezing children with rhinovirus infection.

The secondary objectives are to determine duration and severity of each acute episode with acute expiratory breathing difficulty, the number of episodes with acute expiratory breathing difficulty, degree of pulmonary hyperreactivity and quality of life within 24 months after study entry.


Condition or disease Intervention/treatment Phase
Asthma Inflammation Drug: Dexamethasone treatment during 3 days Drug: placebo treatment during 3 days Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In Sweden and Finland children who are rhinovirus negative but otherwise fulfill the inclusion criteria, will be included for comparison. They will not be randomized and participate in the intervention but receive follow-up as rhinovirus positive participants.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing - the INSTAR Study
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Dexamethasone Drug: Dexamethasone treatment during 3 days
Dexamethasone 1,5 mg oral tablets, may be halved into 2 x 0,75 mg. The exact daily dose of dexamethasone will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.

Placebo Comparator: controls Drug: placebo treatment during 3 days
1,5 mg oral tablets, may be halved into 2 x 0,75 mg. The exact daily dose of lactose (instead of dexamethasone) will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.
Other Name: lactose




Primary Outcome Measures :
  1. time to a new physician-confirmed wheezy episode within 24 months after study entry [ Time Frame: 24 months ]
  2. time to need for a regular controller medication for asthma within 24 months after study entry [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. duration of respiratory symptoms [ Time Frame: 24 months ]
    as determined at the first episode of acute breathing difficulty within 24 months of study entry

  2. severity of respiratory symptoms [ Time Frame: 24 months ]
    as determined at the first episode of acute breathing difficulty within 24 months of study entry

  3. the number of episodes with acute breathing difficulty since start of study medication [ Time Frame: 24 months ]
    as determined at scheduled follow-up visit within 24 months of study entry

  4. the duration of episodes with acute breathing difficulty since start of study medication [ Time Frame: 24 months ]
    as determined at scheduled follow-up visit within 24 months of study entry

  5. the degree of pulmonary hyperreactivity [ Time Frame: 24 months ]
    as determined at scheduled follow-up visit within 24 months of study entry

  6. quality of life: Infant Toddler Quality of Life© (ITQOL©) questionnaire [ Time Frame: 24 months ]
    as determined at scheduled follow-up visit within 24 months of study entry

  7. body height [ Time Frame: 24 months ]
  8. body weight [ Time Frame: 24 months ]


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Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • admitted to pediatric acute wards in the participating hospitals in Norway, Finland, Sweden.
  • referred for first severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms
  • one or more of the following:(a) fever, (b) hypoxia (SAT O2 <= 92%), (c) retractions (inter-, subcostal), (d) prolonged expiration (on auscultation), (e) expiratory rhonchi (on auscultation)
  • rhinovirus positive PCR test in nasopharyngeal secrete
  • signed informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion Criteria:

  • previous episodes with wheezing, defined as a history of acute breathing difficulty with wheezing in need of treatment at a general practitioner or at hospital, or parental information about similar breathing difficulties
  • gestational age <37 weeks
  • chronic illness other than atopy (eczema),
  • previous systemic or inhaled corticosteroid treatment,
  • participation to another trial,
  • varicella infection or contact during the last 2-3 weeks,
  • need for intensive care unit treatment during the present infection, except for respiratory support with high flow nasal cannula ventilation,
  • any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).

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): NCT03889743


Contacts
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Contact: Henrik Døllner, md phd 0047 73559531 henrik.dollner@ntnu.no

Locations
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Finland
Turku University Hospital Recruiting
Turku, Finland
Contact: Tuomas Jartti, md phd         
Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Marit Vollsaether, md phd         
Akershus University Hospital Recruiting
Oslo, Norway
Contact: Chris Inchley, md phd         
Ullevål University Hospital Recruiting
Oslo, Norway
Contact: Håvard Skjerven         
Stavanger University Hospital Recruiting
Stavanger, Norway
Contact: Knut Øymar, md phd         
University Hospital of North Norway Recruiting
Tromsø, Norway
Contact: Claus Klingenberg, md phd         
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Henrik Døllner, md phd       henrik.dollner@ntnu.no   
Sweden
Karolinska Universitetssjukhuset Recruiting
Stockholm, Sweden
Contact: Jon Konradsen, md phd         
Sponsors and Collaborators
St. Olavs Hospital
Turku University Hospital
Karolinska University Hospital
Haukeland University Hospital
University Hospital, Akershus
Helse Stavanger HF
University Hospital of North Norway
Ullevaal University Hospital
Investigators
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Study Director: Elisabeth Selvaag St. Olavs Hospital
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03889743    
Other Study ID Numbers: 2018/1495
2015-001077-40 ( EudraCT Number )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Respiratory Sounds
Steroids
Rhinovirus
Additional relevant MeSH terms:
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Asthma
Inflammation
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents