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The clinical and immunological effects of short-term preseasonal grass pollen immunotherapy in patients with allergic rhinitis sensitized to grass pollens

Short-term preseasonal grass pollen allergoid immunotherapy in patients with allergic rhinitis sensitized to grass pollens: Clinical and immunological effects

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000484741
Enrollment
31
Registered
2013-05-01
Start date
2009-05-25
Completion date
2009-05-29
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The present randomized, double-blind, placebo-controlled study aimed to investigate the immunological and clinical effects of short-term preseasonal grass pollen allergoid immunotherapy in allergic rhinitis.

Interventions

Subjects were randomized to receive active preseasonal short-term grass pollen allergoid immunotherapy or placebo using a double-blind method. The immunotherapy product was a preparation of extracts of six-grass pollens treated with formaldehyde to produce an allergoid and adsorbed onto aluminium hydroxide. It was supplied in two concentrations, 1000 therapeutic units (TU)/ml and 10000 TU/ml. Subcutaneous injections commenced before the onset of the pollen season with 0.1 ml of 1000 TU/ml in Feb

Subjects were randomized to receive active preseasonal short-term grass pollen allergoid immunotherapy or placebo using a double-blind method. The immunotherapy product was a preparation of extracts of six-grass pollens treated with formaldehyde to produce an allergoid and adsorbed onto aluminium hydroxide. It was supplied in two concentrations, 1000 therapeutic units (TU)/ml and 10000 TU/ml. Subcutaneous injections commenced before the onset of the pollen season with 0.1 ml of 1000 TU/ml in February 2010 and followed by an approximate doubling of the dose weekly up to 0.6 ml of 10000 TU/ml. The standard regimen comprised of seven injections, once weekly, for seven weeks. Dose adjustments were made according to individual tolerance. The highest grass pollen grains are recorded between April and August in Turkey. Due to different times of pollination of the members of the Gramineae family, Gramineae pollens are usually found in the air during the whole year except a few months in Turkey. We used 01 March - 01 September as the pollen period in this trial and followed up participants for six months after the administration of the last injection.

Sponsors

Zeynep Misirligil
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
17 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

History of seasonal allergic rhinitis caused by grass pollens, positive skin prick test result (wheal diameter =3 mm) to grass pollen extract, no inhalant allergen sensitization other than pollens

Exclusion criteria

Presence of asthma, previous allergen immunotherapy, inhalant allergen sensitization other than pollens, pregnant women, presence of severe systemic disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026