Research on Underlying Causes of Long-term Use of Nasal Decongestants and the Structured Withdrawal of the Decongestant

The study comprises two parts:

• Part A: Characterisation study (both healthy volunteers and patients with long-term use of nasal decongestants)
• Part B: Intervention study (only patients with long-term use of nasal decongestants). Patients will be rescreened prior to inclusion into part B of the study. Participants will receive the intervention (Mometasone furoate nasal spray) during a 12-week period

Part A (characterisation study) consists of three study-related contact moments:

• Screening visit
• Telephone contact
• Ear-, nose- and throat examination (actual characterisation study)

Part B (intervention study) consists of five contact moments:

• Start-up of the intervention
• Telephone contact (during follow-up 1 period)
• Follow-up 1 (After 6 weeks of intervention*)
• Follow-up 2 (After 12 weeks of intervention*)
• Telephone follow-up (6 months post start-up of the intervention*) * Study windows foreseen in the protocol

Procedures performed during part A of the study:

• Peak Nasal Inspiratory Flow (PNIF) measurements
• Nasal endoscopy
• Collection of blood samples and nasal secretions
• Completion of questionnaires
• Completion of patient diary
• Collection of data regarding medication use
• Skin prick testing
• Completion of patient diary
• Medical photography of the face and nose
• Telephone follow-up

Procedures performed during part B of the study:

• Urine pregnancy test
• Collection of data regarding medication use
• Counselling conversations with the researchers
• Completion of questionnaires
• Completion of patient diary
• Drug accountability
• Daily administration of Mometasone furoate (by the patients themselves, during a 12 week period)
• PNIF measurements
• Nasal endoscopy
• Collection of blood samples and nasal secretions
• Telephone follow-up

Inclusion criteria

Healthy Volunteers (only included in part A of the study):

• Aged 18 years or older
• Sufficient knowledge of the Dutch language

Exclusion criteria

Healthy Volunteers (only included in part A of the study):

• Subjective presence of nasal disease (i.e. the study subject indicates to experience any nasal symptoms, an occasional common cold not taken into account)
• Established diagnosis of a nasal disorder (e.g. allergy, nasal polyps, …) or a positive allergy test (skin prick test or blood test)
• Prior nasal surgery
• Asthma
• Use of an oral corticosteroid in the month prior to the screening visit
• Significant disease(s) that might interfere with the study, based on the judgement of the investigator
• Current use of a nasal decongestant, more than two episodes of 7 days use of a nasal decongestant in the previous year or less than two episodes of 7 days use (in the previous year) but last use less than a month prior to the screening visit
• Other medication used to treat nasal symptoms (intranasal corticosteroids, oral or intranasal antihistamines, oral decongestants …)
• History of rhinitis medicamentosa (either patient-reported long-term use of a nasal decongestant or a diagnosis of rhinitis medicamentosa)
• Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding

Inclusion criteria

patients with long-term use of nasal decongestants: part A:

• Aged 18 years or older
• Daily use of a nasal decongestant for at least 6 months. Following ATC-codes are considered, when the spray or drops contain a nasal decongestant and the drug is thus intended for short-term use only: R01AA, R01AB, R01AD52, R01AD53
• Sufficient knowledge of the Dutch language

Exclusion criteria

patients with long-term use of nasal decongestants: part A:

• Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
• Use of an oral corticosteroid in the month prior to the screening visit
• Use of an oral decongestant in the week prior to the screening visit
• Significant disease(s) that might interfere with the study, based on the judgement of the investigator

Inclusion criteria

patients with long-term use of nasal decongestants: part B:

• Aged 18 years or older
• Daily use of a nasal decongestant for at least 6 months.Following ATC-codes are considered, when the spray or drops contain a nasal decongestant and the drug is thus intended for short-term use only: R01AA, R01AB, R01AD52, R01AD53
• Sufficient knowledge of the Dutch language

Exclusion criteria

patients with long-term use of nasal decongestants: part B:

• Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
• Glaucoma
• Use of an oral corticosteroid in the month prior to the start of the intervention
• Use of an oral decongestant in the week prior to the start of the intervention
• Significant disease(s) that might interfere with the study, based on the judgement of the investigator