Seasonal Allergic RhinitisPhase 1/2NCT04817800
To Investigate Drug-drug Interaction and Relative Bioavailability Between the FDC AzelastineHCL/Beclomethasone Dipropionate Nasal Spray, & Beclomethasone Dipropionate Nasal Spray in the Test Vehicle, and RinoClenil® Nasal Spray
A Phase 1/2 study testing 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) in people with Seasonal Allergic Rhinitis, run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.
Trial summary
An open label, randomized, three-treatment, three-period, crossover, single dose study, to investigate drug-drug interaction and relative bioavailability between the fixed dose combination Azelastine hydrochloride / Beclomethasone dipropionate (140/100 μg Azelastine hydrochloride / Beclomethasone dipropionate) Nasal… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteJordan
- Study dates
- 25 Mar 2021to 10 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is Caucasian \& aged between eighteen \& fifty years (18 - 50), both inclusive.
- The subject is within the limits for his height \& weight as defined by the body mass index range
- (18.5 - 30.0 Kg/m2).
- The subject is willing to undergo the necessary pre- \& post- medical examinations set by this
- study.
- The results of medical history, vital signs, physical examination \& conducted medical laboratory
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- tests are normal as determined by the clinical investigator.
- The subject tested negative for hepatitis (HBsAg, HCVAb) viruses and human immunodeficiency
- virus (HIVAb).
- There is no evidence of psychiatric disorder, antagonistic personality and poor motivation,
- emotional or intellectual problems likely to limit the validity of consent to participate in the study
- or limit the ability to comply with protocol requirements.
- The subject is able to understand and willing to sign the informed consent form.
- For female subjects: negative pregnancy test and the woman is using two reliable contraception
- methods \& should be non-lactating.
- The subject has normal cardiovascular system and ECG recording.
- The subject kidney and liver (AST \& ALT enzymes) functions tests are within normal range.
Who cannot join
- The subject is smoker/ has positive cotinine test.
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent abuse of alcohol.
- The subject has a history of or concurrent abuse of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug, its
- excipients and any related compounds.
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- The subject has been hospitalized within three months before the study or during the study.
- The subject is vegetarian.
- The subject has consumed caffeine or xanthine containing beverages or foodstuffs within two days
- before dosing and until 23 hours after dosing in all study periods.
- The subject has taken a prescription medication within two weeks or even an over the counter
- product (OTC) within one week before dosing in each study period and any time during the study,
- unless otherwise judged acceptable by the clinical investigator.
- The subject has taken grapefruit containing beverages or foodstuffs within seven (7) days before
- first dosing and any time during the study.
- The subject has been participating in any clinical study (e.g. pharmacokinetics, bioavailability and
- bioequivalence studies) within the last 80 days prior to the present study.
- The subject has donated blood within 80 days before first dosing.
- The subject has a history or presence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal,
- hematological, endocrinal, immunological, dermatological, neurological, musculoskeletal or
- psychiatric diseases.
- The subject has consumed drugs that may affect pharmacological or pharmacokinetic properties
- (ritonavir, cobicistat \& CNS depressants) two weeks before dosing, during the study and two
- weeks after dosing.
- The subject has recent nose surgery or a history of chronic sinusitis, recent URTI and nasal septum
- deviation that may affect nasal mucosa integrity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Three-treatment, Three-period, Crossover, Single Dose Study, to Investigate Drug-drug Interaction and Relative Bioavailability Between the Fixed Dose Combination Azelastine Hydrochloride / Beclomethasone Dipropionate (140/100 μg Azelastine Hydrochloride / Beclomethasone Dipropionate) Nasal Spray, and Beclomethasone Dipropionate Nasal Spray (100 μg Beclomethasone Dipropionate) in the Test Vehicle, and the Commercially Available Product, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate), in Healthy Subjects Under Fasting Conditions
An open label, randomized, three-treatment, three-period, crossover, single dose study, to investigate drug-drug interaction and relative bioavailability between the fixed dose combination Azelastine hydrochloride / Beclomethasone dipropionate (140/100 μg Azelastine hydrochloride / Beclomethasone dipropionate) Nasal Spray, and Beclomethasone Dipropionate Nasal Spray (100 μg Beclomethasone Dipropionate) in the test vehicle, and the commercially available product, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate), in healthy subjects under fasting conditions.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)Drug
Also called 100 μg Beclomethasone dipropionate, Nasal Spray, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)
It will be nasaly administered
| Study group | Role | What they receive |
|---|---|---|
| 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) | Experimental | Not described Receives: Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) |
| 100 μg Beclomethasone dipropionate, Nasal Spray | Experimental | Not described Receives: Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) |
| RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate) | Active comparator | Not described Receives: Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
Measured: 23 hours
area under the plasma concentration versus time curve (AUC) from pre-dose (time zero) to the last sampling time with quantifiable concentrations (AUC0-t) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
Measured: 23 hours
AUC from time zero to infinity (AUC0-∞) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
Measured: 23 hours
Secondary outcomes (4)
Obtaining the Tmax (Time to reach maximum concentration)
The descriptive statistics including Maximum, Minimum and Median values will be measured for Tmax.
Measured: 23 hours
Blood pressure (safety and tolerability)
Clinically significant abnormal deviations. Normal range of blood pressure > 90/60 and <140/90 mmHg. Treatment will be offered to those subjects whom blood pressure drops to 90/60 mm Hg or less and the subject will be excluded in case of not responding to treatment.
Measured: At 1 hour pre-dosing and 2, 4, 6, 8, 12, and 23 hours post dosing,
Pulse (safety and tolerability)
Clinically significant abnormal deviations. Normal range of Pulse 60-100 Bpm.
Measured: At 1 hour pre-dosing and 2, 4, 6, 8, 12, and 23 hours post dosing,
Temperature (safety and tolerability)
Clinically significant abnormal deviations. The temperature will be measured axillary, orally or using infrared thermometer, standardized across all subjects. Normal range of temperature 36.5-37.5 ºC.
Measured: At 1 hour pre-dosing and 2, 6, 10, 14, 18, 22 and 23 hours post dosing,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start25 Mar 2021
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hakan Gürpınar, Study director, Humanis Saglık
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817800
- Sponsor's protocol ID
- 980-2020
- Status last verified
- Dec 2023
- First submitted
- 19 Mar 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Three-treatment, Three-period, Crossover, Single Dose Study, to Investigate Drug-drug Interaction and Relative Bioavailability Between the Fixed Dose Combination Azelastine Hydrochloride / Beclomethasone Dipropionate (140/100 μg Azelastine Hydrochloride / Beclomethasone Dipropionate) Nasal Spray, and Beclomethasone Dipropionate Nasal Spray (100 μg Beclomethasone Dipropionate) in the Test Vehicle, and the Commercially Available Product, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate), in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT04817800
- Acronym / sponsor ID
- 980-2020
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Humanis Saglık Anonim SirketiIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open label, randomized, three-treatment, three-period, crossover, single dose study, to investigate drug-drug interaction and relative bioavailability between the fixed dose combination Azelastine hydrochloride / Beclomethasone dipropionate (140/100 μg Azelastine hydrochloride / Beclomethasone dipropionate) Nasal Spray, and Beclomethasone Dipropionate Nasal Spray (100 μg Beclomethasone Dipropionate) in the test vehicle, and the commercially available product, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate), in healthy subjects under fasting conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) | Experimental | Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) |
| 100 μg Beclomethasone dipropionate, Nasal Spray | Experimental | Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) |
| RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate) | Active comparator | Drug: 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- The subject is Caucasian \& aged between eighteen \& fifty years (18 - 50), both inclusive.
- The subject is within the limits for his height \& weight as defined by the body mass index range
- (18.5 - 30.0 Kg/m2).
- The subject is willing to undergo the necessary pre- \& post- medical examinations set by this
- study.
Key exclusion criteria (26 listed)
- The subject is smoker/ has positive cotinine test.
- The subject has suffered an acute illness one week before dosing.
- The subject has a history of or concurrent abuse of alcohol.
- The subject has a history of or concurrent abuse of illicit drugs.
- The subject has a history of hypersensitivity and/or contraindications to the study drug, its
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 |
|---|---|---|
| 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)Also: 100 μg Beclomethasone dipropionate, Nasal Spray, RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate)It will be nasaly administered | Drug | 100 μg Beclomethasone dipropionate, Nasal Spray, 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate), RinoClenil® Nasal Spray (100 μg Beclomethasone Dipropionate) |
Primary outcome
Maximum observed plasma concentration (Cmax) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
Time frame: 23 hours
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval. For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
area under the plasma concentration versus time curve (AUC) from pre-dose (time zero) to the last sampling time with quantifiable concentrations (AUC0-t) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
Time frame: 23 hours
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval. For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
AUC from time zero to infinity (AUC0-∞) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate
Time frame: 23 hours
For the assessment of a potential drug-drug interaction, no effect of Azelastine on the pharmacokinetics of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate will be concluded if the fixed dose combination Test-to-mono test GMR and the corresponding 90% CI of the ln-transformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval. For the assessment of the relative bioavailability, bioequivalence between Beclomethasone dipropionate drug products will be concluded if the fixed dose combination test-to-mono reference GMR and the corresponding 90% CI of the Lntransformed primary pharmacokinetic parameters are within the 80.00% to 125.00% acceptance interval.
4 secondary outcomes
Obtaining the Tmax (Time to reach maximum concentration)
Time frame: 23 hours
Blood pressure (safety and tolerability)
Time frame: At 1 hour pre-dosing and 2, 4, 6, 8, 12, and 23 hours post dosing,
Pulse (safety and tolerability)
Time frame: At 1 hour pre-dosing and 2, 4, 6, 8, 12, and 23 hours post dosing,
Temperature (safety and tolerability)
Time frame: At 1 hour pre-dosing and 2, 6, 10, 14, 18, 22 and 23 hours post dosing,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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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.
Hakan Gürpınar study director
Humanis Saglık
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate) in people with Seasonal Allergic Rhinitis, run by Humanis Saglık Anonim Sirketi at 1 site in Jordan.
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 17 inclusion and 26 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 13 Dec 2023. 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 Jordan. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum observed plasma concentration (Cmax) of Beclomethasone dipropionate and its active metabolite Beclomethasone 17-monopropionate (time frame: 23 hours). The study lists 3 primary outcomes in all. 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 13 Dec 2023.