Allergic RhinitisPhase 1NCT00836914
Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
A Phase 1 study testing CAL-101 in people with Allergic Rhinitis, run by Gilead Sciences at 1 site in Austria.
Trial summary
The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- CAL-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteAustria
- Study dates
- Feb 2009to Mar 2009
- Phase
- Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age > or = 18 and < or = 55 years
- Has a history of seasonal allergic rhinitis for at least 2 years
- Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
- Has a positive Radio Allergen Sorbent Test (> or = class 2) for grass pollen during the previous 12 months or at screening
- Is otherwise healthy, that is, free from clinically significant illness or disease as determined by medical history, physical examination and laboratory tests, including a normal 12-lead electrocardiogram (ECG)
- Has no conditions which would make the subject unlikely to be able to remain in the allergen challenge chamber for 4 hours
- Is available to complete all study procedures
- Is able to provide written informed consent, including compliance with the requirements and restrictions listed in the consent form
Who cannot join
- Is a female of childbearing potential (non-childbearing potential means documented surgery resulting in infertility or postmenopausal with no menses for at least 1 year)
- History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
- History of nonallergic rhinitis, chronic sinusitis or severe asthma
- Has a nasal condition likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases
- Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies, e.g. St. John's Wort. Paracetamol (< or = 2g/day) and as needed use of short-acting B2-agonists are allowed.
- Has taken a prohibited medication within the specified interval prior to Visit 1:
Show all 17Show fewer
- Corticosteroids (depot, 90 days; systemic, 30 days; dermatologic 14 days)
- Chromones (14 days)
- Antihistamines (nasal and long-acting oral, 10 days; shorting-acting oral, 2 days; ocular, 3 days)
- Decongestants (3 days)
- Leukotriene modifiers (10 days)
- Anticholinergics (7 days)
- Opthalmic nonsteroidal
- anti-inflammatory drugs (3 days)
- Nasal-ophthalmic wash solutions (12 hr)
- Immunotherapy (12 hr)
- Is currently being treated with a medication that induces or inhibits cytochrome P450 (CYP)3A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-101 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge
The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.
Read the detailed description
A Phase I, randomized, double-blind crossover study of CAL-101, an oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta, in patients with allergic rhinitis.
- Conditions
- Allergic Rhinitis
- Being tested
- CAL-101, Placebo
- Keywords
- Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase
- Medical subject headings
- Rhinitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAL-101Drug
Also called Idelalisib, GS-1101
CAL-101 100mg capsules administered orally twice a day (BID) for 7 days
PlaceboDrug
Placebo capsules administered orally BID for 7 days
| Study group | Role | What they receive |
|---|---|---|
| CAL-101 | Active comparator | Not described Receives: Drug: CAL-101 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG
Measured: Baseline to Day 35
Secondary outcomes (1)
Change from baseline in total nasal symptom score
Measured: Baseline to Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Friedrich Horak, MD, Principal investigator, Vienna Challenge Chamber
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836914
- Sponsor's protocol ID
- 101-04
- Status last verified
- Jan 2013
- First submitted
- 2 Feb 2009
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Publications
Horak F, Puri KD, Steiner BH, Holes L, Xing G, Zieglmayer P, Zieglmayer R, Lemell P, Yu A. Randomized phase 1 study of the phosphatidylinositol 3-kinase delta inhibitor idelalisib in patients with allergic rhinitis. J Allergy Clin Immunol. 2016 Jun;137(6):1733-1741. doi: 10.1016/j.jaci.2015.12.1313. Epub 2016 Feb 23.
PubMed 26915677
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Period Crossover Study to Investigate the Safety of CAL-101 in Allergic Rhinitis Subjects and Effects on the Response to Environmental Chamber Allergen Challenge
- ClinicalTrials.gov ID
- NCT00836914
- Acronym / sponsor ID
- 101-04
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Allergy, Phosphatidylinositol 3-kinase
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Feb 2009 (estimated)
- 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.
The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.
Detailed description
A Phase I, randomized, double-blind crossover study of CAL-101, an oral inhibitor of phosphatidylinositol 3-kinase (PI3K) delta, in patients with allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAL-101 | Active comparator | Drug: CAL-101 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age > or = 18 and < or = 55 years
- Has a history of seasonal allergic rhinitis for at least 2 years
- Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing
- Has a positive Radio Allergen Sorbent Test (> or = class 2) for grass pollen during the previous 12 months or at screening
- Is otherwise healthy, that is, free from clinically significant illness or disease as determined by medical history, physical examination and laboratory tests, including a normal 12-lead electrocardiogram (ECG)
Key exclusion criteria (17 listed)
- Is a female of childbearing potential (non-childbearing potential means documented surgery resulting in infertility or postmenopausal with no menses for at least 1 year)
- History of chronic nasal or upper respiratory tract symptoms or disorders other than allergic rhinitis
- History of nonallergic rhinitis, chronic sinusitis or severe asthma
- Has a nasal condition likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases
- Is currently taking regular medication, whether prescribed or not, including corticosteroids, vitamins, macrolides, anti-fungal agents and herbal remedies, e.g. St. John's Wort. Paracetamol (< or = 2g/day) and as needed use of short-acting B2-agonists are allowed.
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 |
|---|---|---|
| CAL-101Also: Idelalisib, GS-1101CAL-101 100mg capsules administered orally twice a day (BID) for 7 days | Drug | CAL-101 |
| PlaceboPlacebo capsules administered orally BID for 7 days | Drug | Placebo |
Primary outcome
Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG
Time frame: Baseline to Day 35
1 secondary outcome
Change from baseline in total nasal symptom score
Time frame: Baseline to Day 35
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 23 Oct 2018.
- Derived from this study: PubMed 26915677Horak F, Puri KD, Steiner BH, Holes L, Xing G, Zieglmayer P, Zieglmayer R, Lemell P, Yu A. Randomized phase 1 study of the phosphatidylinositol 3-kinase delta inhibitor idelalisib in patients with allergic rhinitis. J Allergy Clin Immunol. 2016 Jun;137(6):1733-1741. doi: 10.1016/j.jaci.2015.12.1313. Epub 2016 Feb 23.
- Individual participant dataSharing planned: Yes. Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
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.
Friedrich Horak, MD principal investigator
Vienna Challenge Chamber
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 CAL-101 in people with Allergic Rhinitis, run by Gilead Sciences at 1 site in Austria.
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 8 inclusion and 17 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 23 Oct 2018. 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 Austria. 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. Some participants in this study may receive a placebo. 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?
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?
Evaluate the safety CAL-101 using adverse events, vital signs, clinical laboratory tests, spirometry and ECG (time frame: Baseline to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00836914, which also lists 1 linked publication.
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 23 Oct 2018.