Allergic Rhinitis (AR)Phase 1NCT01371786
A Phase 1 Scintigraphy Study to Assess Nasal Deposition of Ciclesonide. Using a Novel Nasal Metered Dose Inhaler
A Phase 1 study testing ciclesonide nasal aerosol and mometasone Aqueous (AQ) nasal spray in people with Allergic Rhinitis (AR), run by Sumitomo Pharma America, Inc. at 1 site in United Kingdom.
Trial summary
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone furoate monohydrate radiolabeled suspension via an… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis (AR)
- What is being tested?
- ciclesonide nasal aerosol and mometasone Aqueous (AQ) nasal spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Aug 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has give written informed consent and agrees to adhere to concomitant medication withholding periods, prior to participation.
- Patient is aged 18-65 years, inclusive.
- Patient has a Body Mass Index (BMI) of 18-30 kg/m2, inclusive
- Patient must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis).
- A history of perennial or seasonal allergic rhinitis confirmed on GP report, or clinical diagnosis of perennial or seasonal allergic rhinitis confirmed at screening.
- A demonstrated sensitivity at the Screening visit, or within the 90 days prior to screening, to at least one allergen known to induce PAR (house dust mite, animal dander, cockroach, and molds) or SAR (grass pollen, tree pollen and weed pollen) using a 3 mm response to a standard skin prick test. The patient's positive allergen test must be consistent with the medical history of PAR/SAR.
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- Must be willing and able to communicate and participate in the whole study.
- Patients must refrain from taking medication for allergic rhinitis, from Screening until completion of second dosing period.
- Patients, if female, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
- An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
- Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- True abstinence, when this is in line with the preferred and usual lifestyle of the patient (if the patient is usually not sexually active but becomes active, they with their partner, must use an acceptable method of birth control).
Who cannot join
- Female patient who is pregnant or lactating.
- Patient has radiation exposure from clinical trials, including that from the present study, excluding background radiation but including diagnostic X rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
- Patient has an abnormality on physical examination that, in the investigator's opinion, would affect nasal airway resistance, including: nasal jewelry or piercings; nasal pathology such as nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations.
- Patient has a history of cocaine or glue sniffing.
- Nasal surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to the Screening visit.
- Patient is a smoker (based on results of breath carbon monoxide testing at screening; ie, ≥10 ppm).
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- Active asthma requiring treatment with inhaled or systemic corticosteroids and/or routine use of beta agonists and any controller drugs (eg, theophylline, leukotriene antagonists, etc.); intermittent use (less than or equal to 3 uses per week) of inhaled short acting beta agonists is acceptable. Use of short acting beta agonists for exercise induced bronchospasm will be allowed.
- Patient has a history of any chronic respiratory disorder including active or quiescent pulmonary tuberculosis.
- Patient has a history of adverse reaction or allergy to ciclesonide, mometasone, other corticosteroids, or formulation excipients.
- Patient has a Screening forced expiratory volume (FEV1) <80% of the predicted value for their age, sex, height and race.
- Patient has had an upper respiratory tract infection (excluding otitis media) within 14 days of first dosing period, or a lower respiratory tract infection within 3 months of the first study day.
- Previous participation in an intranasal ciclesonide HFA nasal aerosol study; participation in any investigational drug trial within the 60 days preceding the Screening visit or planned participation in another investigational drug trial at any time during this trial.
- History of alcohol or drug abuse within 2 years preceding the Screening visit.
- Study participation by clinical investigator site employees and/or their relatives or by more than one patient from the same household.
- Have any of the following conditions that are judged by the investigator to be clinically significant and/or affect the patients availability to participate in the clinical trial:
- impaired hepatic function including alcohol related liver disease or cirrhosis
- history of ocular disturbances, eg, glaucoma or posterior subcapsular cataracts
- any systemic infection including a history of a positive test for HIV, hepatitis B or hepatitis C.
- hematological, hepatic, renal, endocrine (except for controlled diabetes mellitus or postmenopausal symptoms or hypothyroidism)
- gastrointestinal disease
- malignancy (excluding basal cell carcinoma)
- current neuropsychological condition with or without drug therapy
- Any condition that, in the judgment of the investigator, would preclude the patient from completing the protocol with capture of the assessments as written.
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Ruddington Fields, Ruddington, NG11 6JS
About this study
Official title: A Phase 1, Open Label, Two Period, Randomized, Cross Over Scintigraphy Study Assessing Nasal Deposition of a Single Dose of a Ciclesonide Radiolabeled Solution Following Nasal Inhalation of a Novel Nasal Metered Dose Inhaler (MDI) and of a Mometasone Furoate Monohydrate Radiolabeled Suspension Via an Aqueous (AQ) Nasal Spray
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14 patients with symptomatic allergic rhinitis, aged 18-65 years.
Read the detailed description
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10 14 patients with symptomatic allergic rhinitis, aged 18 65 years. In order to ensure that patients will be symptomatic at the time of dosing, participants will be asked to withhold their usual treatments for perennial or seasonal allergic rhinitis, beginning at the Screening Visit until after Study Visit 3.
Each patient will be randomly assigned to one of two treatment sequences. The two treatments in this study are a single dose (one 37 mcg actuation per nostril) of radiolabeled solution of ciclesonide nasal aerosol 74 µg (Regimen A) and a single dose (two 50 mcg actuations per nostril) of a radiolabeled suspension of mometasone aqueous nasal spray 200 µg (Regimen B).
- Conditions
- Allergic Rhinitis (AR)
- Being tested
- ciclesonide nasal aerosol, mometasone Aqueous (AQ) nasal spray
- Keywords
- Ciclesonide, Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclesonide nasal aerosolDrug
A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
mometasone Aqueous (AQ) nasal sprayDrug
A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
| Study group | Role | What they receive |
|---|---|---|
| ciclesonide nasal aerosol | Experimental | A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle Receives: Drug: ciclesonide nasal aerosol |
| mometasone | Active comparator | A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister Receives: Drug: mometasone Aqueous (AQ) nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose
The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.
Measured: Day 1 at 2 minutes post dose
Secondary outcomes (4)
Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose
The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasopharynx, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.
Measured: Day 1 at 2 minutes post-dose
Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose
The scintigraphic measure of radioactivity deposited within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.
Measured: Average of 2, 4, 6, 8 and 10 minutes post dose
Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose
The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.
Measured: Day 1 at 2 minutes post-dose
Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose
The scintigraphic measure of radioactivity deposited on nasal wipes, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), over 10 minutes (at approximately 2 minute intervals post-dose) following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.
Measured: Average of 2, 4, 6, 8, and 10 minutes post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic Rhinitis (AR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371786
- Sponsor's protocol ID
- 060-102
- Status last verified
- Sep 2012
- First submitted
- 9 Jun 2011
- Last updated
- 10 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Two Period, Randomized, Cross Over Scintigraphy Study Assessing Nasal Deposition of a Single Dose of a Ciclesonide Radiolabeled Solution Following Nasal Inhalation of a Novel Nasal Metered Dose Inhaler (MDI) and of a Mometasone Furoate Monohydrate Radiolabeled Suspension Via an Aqueous (AQ) Nasal Spray
- ClinicalTrials.gov ID
- NCT01371786
- Acronym / sponsor ID
- 060-102
- Conditions
- Allergic Rhinitis (AR)
- Keywords
- Ciclesonide, Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Posted 6 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal Metered Dose Inhaler (MDI) and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10-14 patients with symptomatic allergic rhinitis, aged 18-65 years.
Detailed description
This study is an open label, single dose, single site, randomized, cross over study that will assess nasal deposition of radioactivity following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and of a mometasone furoate monohydrate radiolabeled suspension via an aqueous nasal spray in approximately 10 14 patients with symptomatic allergic rhinitis, aged 18 65 years. In order to ensure that patients will be symptomatic at the time of dosing, participants will be asked to withhold their usual treatments for perennial or seasonal allergic rhinitis, beginning at the Screening Visit until after Study Visit 3.
Each patient will be randomly assigned to one of two treatment sequences. The two treatments in this study are a single dose (one 37 mcg actuation per nostril) of radiolabeled solution of ciclesonide nasal aerosol 74 µg (Regimen A) and a single dose (two 50 mcg actuations per nostril) of a radiolabeled suspension of mometasone aqueous nasal spray 200 µg (Regimen B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ciclesonide nasal aerosol | Experimental | Drug: ciclesonide nasal aerosolA radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle |
| mometasone | Active comparator | Drug: mometasone Aqueous (AQ) nasal sprayA radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient has give written informed consent and agrees to adhere to concomitant medication withholding periods, prior to participation.
- Patient is aged 18-65 years, inclusive.
- Patient has a Body Mass Index (BMI) of 18-30 kg/m2, inclusive
- Patient must be in general good health (defined as the absence of any clinically relevant abnormalities as determined by the Investigator) based on screening physical examination, medical history, and clinical laboratory values (Hematology, Chemistries and Urinalysis).
- A history of perennial or seasonal allergic rhinitis confirmed on GP report, or clinical diagnosis of perennial or seasonal allergic rhinitis confirmed at screening.
Key exclusion criteria (24 listed)
- Female patient who is pregnant or lactating.
- Patient has radiation exposure from clinical trials, including that from the present study, excluding background radiation but including diagnostic X rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
- Patient has an abnormality on physical examination that, in the investigator's opinion, would affect nasal airway resistance, including: nasal jewelry or piercings; nasal pathology such as nasal polyps or other clinically significant respiratory tract malformations; recent nasal biopsy; nasal trauma; or nasal ulcers or perforations.
- Patient has a history of cocaine or glue sniffing.
- Nasal surgery and atrophic rhinitis or rhinitis medicamentosa are not permitted within the last 60 days prior to the Screening visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciclesonide nasal aerosolA radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister | Drug | ciclesonide nasal aerosol |
| mometasone Aqueous (AQ) nasal sprayA radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle | Drug | mometasone |
Primary outcome
Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose
Time frame: Day 1 at 2 minutes post dose
The scintigraphic measure of radioactivity initially deposited (approximately 2 minutes post-dose) within the nasal cavity, expressed as a percent of the delivered dose (i.e., the total amount of radioactivity delivered), following nasal inhalation of a ciclesonide radiolabeled solution via a novel nasal MDI and a mometasone radiolabeled suspension via an aqueous nasal spray.
4 secondary outcomes
Initial Deposition of Radioactivity Within the Nasopharynx as a Percent of Delivered Dose
Time frame: Day 1 at 2 minutes post-dose
Deposition of Radioactivity Within the Nasal Cavity Over 10 Minutes as a Percent of Delivered Dose
Time frame: Average of 2, 4, 6, 8 and 10 minutes post dose
Initial Deposition of Radioactivity on Nasal Wipes as a Percent of Delivered Dose
Time frame: Day 1 at 2 minutes post-dose
Deposition of Radioactivity Within on Nasal Wipes Over 10 Minutes as a Percent of Delivered Dose
Time frame: Average of 2, 4, 6, 8, and 10 minutes post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ciclesonide nasal aerosol and mometasone Aqueous (AQ) nasal spray in people with Allergic Rhinitis (AR), run by Sumitomo Pharma America, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial Deposition of Radioactivity Within the Nasal Cavity as a Percent of Delivered Dose (time frame: Day 1 at 2 minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.