Cellulose Powder Against Grass Pollen Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: A nasally applied cellulose powder is increasingly used in many countries as a
      remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children
      showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen
      counts. The present study in grass pollen-allergic adults used the same basic design.
      Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients
      with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were
      used as reminders of treatment and reporting of symptom scores.
    

Detailed description: 
      The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May
      2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a
      history of typical symptoms of seasonal allergic rhinitis (SAR) during late spring - early
      summer. At first appointment the history was scrutinized and an assessment of the severity
      excluded previous use of nasal steroids or a current need for nasal steroids. They should not
      have perennial symptoms or a history of asthma. They were tested with a blood sample for
      ImmunoCAP Specific Immunoglobulin E (IgE) for timothy grass pollen and birch pollen, with
      >0.35 Kilounits (kU)/ml counted as positive.

      The patients were randomly assigned to active or placebo in groups using an identical device
      to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic
      containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered
      is not standardized and the variations of patterns of deposition in the nose are not known.
      The placebo was a lactose powder with the same particle size, appearance and the same tinge
      of mint taste as the cellulose powder.

      Rescue medication could be obtained by the investigators after emergency contacts. Oral
      antihistamine was loratadine 10 mg tablets and sodium chromoglycate eye drops. Each subject
      obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started
      with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment
      during the grass pollen season

      Three times a day the patients were reminded by SMS to take their nasal puffs and were asked
      to confirm the intake by a response SMS. In the evening, they were asked about the severity
      of symptoms during the preceding day from the nose, eyes and lower airways and to answer with
      a figure 1-6, corresponding to 1 "no trouble at all", 2"little trouble", 3"moderate trouble",
      4"rather much trouble", 5"much trouble", and 6 "very much trouble" respectively. From the
      nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and
      lower airways, respectively, only a concluding figure was used.

      In the registration a question was added daily on the use of rescue medication.

      At a concluding appointment after the treatment period, the subjects were asked about their
      global opinion of the efficacy: No effect, good effect, very good effect. They also were
      asked whether they believed they had obtained the active substance or placebo.

      The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May
      2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a
      history of typical symptoms of SAR during late spring - early summer. At first appointment
      the history was scrutinized and an assessment of the severity excluded previous use of nasal
      steroids or a current need for nasal steroids. They should not have perennial symptoms or a
      history of asthma. They were tested with a blood sample for ImmunoCAP Specific IgE for
      timothy grass pollen and birch pollen, with >0.35 kU/ml counted as positive.

      The patients were randomly assigned to active or placebo in groups using an identical device
      to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic
      containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered
      is not standardized and the variations of patterns of deposition in the nose are not known.
      The placebo was a lactose powder with the same particle size, appearance and the same tinge
      of mint taste as the cellulose powder.

      Rescue medication could be obtained by the investigators after emergency contacts. Oral
      antihistamine was loratadine 10 mg tablets and sodium cromoglycate eye drops. Each subject
      obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started
      with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment
      during the grass pollen season

      Three times a day the patients were reminded by SMS to take their nasal puffs and were asked
      to confirm the intake by a response SMS. In the evening, they were asked about the severity
      of symptoms during the preceding day from the nose, eyes and lower airways and to answer with
      a figure 1-6, corresponding to 1 "no trouble at all", 2"little trouble", 3"moderate trouble",
      4"rather much trouble", 5"much trouble", and 6 "very much trouble" respectively. From the
      nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and
      lower airways, respectively, only a concluding figure was used.

      In the registration a question was added daily on the use of rescue medication.

      At a concluding appointment after the treatment period, the subjects were asked about their
      global opinion of the efficacy: No effect, good effect, very good effect. They also were
      asked whether they believed they had obtained the active substance or placebo.

      Statistical methods For each question the mean score was calculated for the whole 28 days
      period for every subject. Mean values for the sum of all scores as well as the sum of the
      nasal scores were also calculated. The scores from the two treatment groups were then
      compared using t-tests. The group comparison of reflective opinions and the guess on obtained
      medication at the follow up visit were assessed using the Chi-square test.

      The concluding opinion at the follow up visit were analysed using the chi-square test.

      The study was approved by the local ethics committees at the respective hospitals.
    

Intervention name(s): Nasaleze; Placebo
Intervention type(s): Device; Device
Intervention description(s): Nasaleze cellulose powder; Lactose powder in the same plastic container as Nasaleze and with the same taste
Other intervention name(s): Nasaval
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment