Assessment of bronchial hyperresponsiveness in children - inhalation of Mannitol compared to eucapnic voluntary hyperventilation and methacholine provocation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003543-67-SE

Enrollment

Registered

2007-09-13

Start date

2007-10-30

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Three different methods to assess airway hyperresponsiveness in children with allergic asthma will be compared.

Interventions

Trade Name: Aridol Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Mannitol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0, 5, 10, 20,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Chidren =6 and =12 years with diagnosis of asthma verified by a paediatrician - Asthma severity corrresponding to level 1,2 or 3 according to the Swedish Paediatric Society´s classification (intermittent or mild persistent). - Asthma control corresponding to level A or B according to the Swedish Paediatric Society´s classification. - Allergy confirmed through RAST or skin prick test. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - FEV1< 70% predicted on spirometry - Respiratory tract infection within 4 weeks before the bronchial challenge tests. - Exposure to allergens to which the child is sensitized within 2 days - The child not beeing able to perform an adequate spirometry

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to compare three different methods to assess airway hyperresponsiveness in children with allergic asthma: - Inhalationof dry powder mannitol - Eucapnic voluntary hyperventilation with dry air - Methacholine provocation test;Secondary Objective: - To investigate how exhaled NO differs before and after the bronchial challenges tests - To assess the patients subjective experience of the different tests, particularly the perception of dyspnea - To generate hypothesis for further studies within the area for instance specificity, applying the test on patients with severe asthma, monitoring response to treatment;Primary end point(s):	—

Measure

Time frame

Main Objective: The primary objective of the study is to compare three different methods to assess airway hyperresponsiveness in children with allergic asthma: - Inhalationof dry powder mannitol - Eucapnic voluntary hyperventilation with dry air - Methacholine provocation test;Secondary Objective: - To investigate how exhaled NO differs before and after the bronchial challenges tests - To assess the patients subjective experience of the different tests, particularly the perception of dyspnea - To generate hypothesis for further studies within the area for instance specificity, applying the test on patients with severe asthma, monitoring response to treatment;Primary end point(s):

—

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026