Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Saskatchewan

About this trial

Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age (years) at least 18 years

no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity as determined by the principal investigator)

baseline FEV1 ≥ 65% of predicted normal at Visit 1

evidence of atopy to an allergen suitable for inhalation challenge following skin prick testing such as house dust mite, grass, cat or horse

Disqualifiers

Smoker >10 pack year history

Trial design

Design model

Crossover

Treatments tested in this trial

  • Tiotropium (Spiriva®)

    Drug

    2 puffs tiotropium prior to allergen challenge

  • Placebo

    Drug

    2 puffs placebo

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Tiotropium treatmentExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Early asthmatic response

Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.

Time frame
2 hours post-allergen challenge

Secondary outcomes

1

Inflammatory response

1\. Evaluate effect of single dose tiotropium versus single dose matched placebo on airway inflammation five hours after allergen challenge through analyses of sputum eosinophil counts, and cytokine analysis including IL-4, 5, 13 and TSLP.

Time frame
Five hours post-allergen challenge
2

FEV1

2\. Evaluate bronchodilating effect of single dose tiotropium versus placebo on baseline lung function by comparing maximal FEV1 pre versus 30 minutes post treatment (i.e. prior to allergen challenge).

Time frame
30 minutes

Other outcomes

Sponsors and contacts

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