Rhinitis, Seasonal, AllergicPhase 2NCT02082054
StahistRx Phase 2, Five-arm, Parallel Group, Active vs Active, Double-blind Study
A Phase 2 study testing PSE 120 mg, CM 8 mg, Atr 0.36 mg, PSE 120 mg, CM 8 mg, Atr 0.24 mg and PSE 120 mg, CM 8 mg, Atr 0.12 mg in people with Rhinitis, Seasonal, Allergic, run by Magna Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Rhinitis, Seasonal, Allergic
- What is being tested?
- PSE 120 mg, CM 8 mg, Atr 0.36 mg, PSE 120 mg, CM 8 mg, Atr 0.24 mg and PSE 120 mg, CM 8 mg, Atr 0.12 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2014to May 2014
- Phase
- Phase 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and females of any ethnic group between 12 and 60 years of age.
- History of moderate to severe SAR for at least two years; defined as having a score of 2 or more on a 0-3 point scale
- Documentation of sensitivity will be obtained from medical records or positive skin testing or in vitro specific IgE test.
- Have a TNSS score of 6 with at least an average of 2.0 in the rhinorrhea sub-score during the placebo-run in phase.
- Is a non-pregnant, non-lactating female who is postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study.
- If female of childbearing potential, must agree to use listed acceptable birth control methods...
Show all 9Show fewer
- If female of childbearing potential, has a negative urine human chorionic gonadotropin (hCG) pregnancy test at screening
- Is able to swallow whole tablets of orally administered medication
- Is able to understand and provide signed informed consent
Who cannot join
- Has asthma requiring corticosteroid treatment
- Is currently undergoing chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent or super potent topical corticosteroids
- Has taken any of the following medications in the indicated time period prior to study enrolment:
- Intranasal, opthalmic, or systemic corticosteroids (1 month)
- Intranasal cromolyn (2 weeks)
- Intranasal or systemic decongestants (3 days)
Show all 20Show fewer
- Intranasal or systemic antihistamines (7 days) or leukotriene inhibitors (7 days)
- Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
- Has a history of allergic reaction to or known sensitivity to the active or inactive ingredients in the investigational products used in this study
- Chronic use of concomitant medications (e.g., tricyclic antidepressants) that would affect assessment of the effectiveness of the study medication
- Rhinitis medicamentosa
- A history of glaucoma
- Has known or suspected pregnancy, planned pregnancy, or lactation (for female patients)
- Is currently receiving immunotherapy, unless at stable maintenance dose for at least 1 month.
- Presence of a medical condition that might interfere with treatment evaluation or require a change in therapy.
- Plans to travel outside the study area for a substantial portion of the study period
- Has a history in the last 2 years or current evidence of abuse of illicit drugs, prescription medications, or alcohol that, in the opinion of the Investigator, would interfere with adherence to study requirements.
- Has exposure to any investigational agent within 30 days prior to study entry.
- Has clinically significant mental illness (to be determined by the Investigator)
- Has a condition the Investigator believes would interfere with the ability to provide informed consent or comply with study instructions, or that might confound the interpretation of the study results or put the patient at undue risk
Trial locations and contacts
4 sites in 1 country.
United States4 sites
National Allergy, Asthma & Urticaria Centers of Charleston, PA
Charleston, South Carolina, 29406
Family Allergy and Asthma Institute
Louisville, Kentucky, 40215
Central Texas Health Research
New Braunfels, Texas, 78130
Clinical Research Atlanta
Stockbridge, Georgia, 30281
About this study
Official title: A Phase 2, Double-Blind, Parallel-Group, Dose-Ranging Study Evaluating Safety/ Efficacy Atropine Doses With Pseudoephedrine and Chlorpheniramine in SAR Patients 12 Years of Age and Older
This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by statistical significance where p < 0.05.
Read the detailed description
Actives in each of the five study arms:
Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.36 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.24 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.12 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg Atropine 0.24 mg
- Conditions
- Rhinitis, Seasonal, Allergic
- Being tested
- PSE 120 mg, CM 8 mg, Atr 0.36 mg, PSE 120 mg, CM 8 mg, Atr 0.24 mg, PSE 120 mg, CM 8 mg, Atr 0.12 mg, PSE 120 mg, CM 8 mg, Atropine 0.24 mg
- Keywords
- rhinitis, seasonal, allergic
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSE 120 mg, CM 8 mg, Atr 0.36 mgDrug
Also called Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropine
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg, Atr 0.24 mgDrug
Also called Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropine
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mg, Atr 0.12 mgDrug
Also called Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropine
Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 mg white, scored, tablets with "M27" on scored side and plain on the other side
PSE 120 mg, CM 8 mgDrug
Also called Pseudoephedrine, chlorpheniramine (Chlor-Trimeton)
Pseudoephedrine 120 mg, chlorpheniramine 8 mg tablets dosed BID
Atropine 0.24 mgDrug
Also called atropine sulfate
Atropine sulfate 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side
| Study group | Role | What they receive |
|---|---|---|
| PSE 120 mg, CM 8 mg, Atr 0.36 mg | Experimental | Pseudoephedrine 120 mg,chlorpheniramine 8 mg, atropine 0.36 mg tablet dosed BID for 7.5 days Receives: Drug: PSE 120 mg, CM 8 mg, Atr 0.36 mg |
| PSE 120 mg, CM 8 mg, Atr 0.24 mg | Experimental | Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg tablets dosed BID for 7.5 days Receives: Drug: PSE 120 mg, CM 8 mg, Atr 0.24 mg |
| PSE 120 mg, CM 8 mg, Atr 0.12 mg | Experimental | Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 dosed BID for 7.5 days Receives: Drug: PSE 120 mg, CM 8 mg, Atr 0.12 mg |
| PSE 120 mg, CM 8 mg | Active comparator | Pseudoephedrine 120 mg, chlorpheniramine 8 mg white, scored, tablets with "M27" on scored side and plain on the other side Receives: Drug: PSE 120 mg, CM 8 mg |
| Atropine 0.24 mg | Experimental | Atropine 0.24 mg tablets dosed BID for 7.5 days Receives: Drug: Atropine 0.24 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-ranging data for atropin
To provide dose-ranging data for atropine and select a dose of Atropine for Phase 3 clinical development using Total Nasal Symptom Score (TNSS) as the primary endpoint plus recording of adverse events
Measured: 7.5 days
Secondary outcomes (1)
Establish effect size for determining power and TNSS efficacy endpoint
To establish an effect size of a Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine combination versus Pseudoephedrine 120 mg/Chlorpheniramine 8 mg to statistically power the pivotal phase of the study using TNSS as the primary endpoint
Measured: 7.5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, Seasonal, AllergicStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magna Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen J Pollard, MD, Principal investigator, Family Allergy and Asthma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082054
- Sponsor's protocol ID
- MAGNA2014-001
- Status last verified
- Feb 2014
- First submitted
- 26 Feb 2014
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Parallel-Group, Dose-Ranging Study Evaluating Safety/ Efficacy Atropine Doses With Pseudoephedrine and Chlorpheniramine in SAR Patients 12 Years of Age and Older
- ClinicalTrials.gov ID
- NCT02082054
- Acronym / sponsor ID
- MAGNA2014-001
- Conditions
- Rhinitis, Seasonal, Allergic
- Keywords
- rhinitis, seasonal, allergic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Magna Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 10 Mar 2014 (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.
This active vs active comparative trial will evaluate the safety and efficacy of incremental doses of atropine in combination with pseudoephedrine 120 mg/chlorpheniramine 8 mg in adult patients with a history of seasonal allergic rhinitis. Hypotheses are defined by total nasal symptom scores (TNSS) recorded by subjects in diaries where efficacy will be established by statistical significance where p < 0.05.
Detailed description
Actives in each of the five study arms:
Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.36 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.24 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg/Atropine 0.12 mg Pseudoephedrine 120 mg/Chlorpheniramine 8 mg Atropine 0.24 mg
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PSE 120 mg, CM 8 mg, Atr 0.36 mg | Experimental | Drug: PSE 120 mg, CM 8 mg, Atr 0.36 mgPseudoephedrine 120 mg,chlorpheniramine 8 mg, atropine 0.36 mg tablet dosed BID for 7.5 days |
| PSE 120 mg, CM 8 mg, Atr 0.24 mg | Experimental | Drug: PSE 120 mg, CM 8 mg, Atr 0.24 mgPseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg tablets dosed BID for 7.5 days |
| PSE 120 mg, CM 8 mg, Atr 0.12 mg | Experimental | Drug: PSE 120 mg, CM 8 mg, Atr 0.12 mgPseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 dosed BID for 7.5 days |
| PSE 120 mg, CM 8 mg | Active comparator | Drug: PSE 120 mg, CM 8 mgPseudoephedrine 120 mg, chlorpheniramine 8 mg white, scored, tablets with "M27" on scored side and plain on the other side |
| Atropine 0.24 mg | Experimental | Drug: Atropine 0.24 mgAtropine 0.24 mg tablets dosed BID for 7.5 days |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Male and females of any ethnic group between 12 and 60 years of age.
- History of moderate to severe SAR for at least two years; defined as having a score of 2 or more on a 0-3 point scale
- Documentation of sensitivity will be obtained from medical records or positive skin testing or in vitro specific IgE test.
- Have a TNSS score of 6 with at least an average of 2.0 in the rhinorrhea sub-score during the placebo-run in phase.
- Is a non-pregnant, non-lactating female who is postmenopausal, naturally or surgically sterile, or who agree to use effective contraceptive methods throughout the course of the study.
Key exclusion criteria (20 listed)
- Has asthma requiring corticosteroid treatment
- Is currently undergoing chronic or intermittent use of inhaled, oral, intramuscular, intravenous, and/or potent or super potent topical corticosteroids
- Has taken any of the following medications in the indicated time period prior to study enrolment:
- Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
- Has a history of allergic reaction to or known sensitivity to the active or inactive ingredients in the investigational products used in this study
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 |
|---|---|---|
| PSE 120 mg, CM 8 mg, Atr 0.36 mgAlso: Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropinePseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with "M27" on scored side and plain on the other side | Drug | PSE 120 mg, CM 8 mg, Atr 0.36 mg |
| PSE 120 mg, CM 8 mg, Atr 0.24 mgAlso: Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropinePseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side | Drug | PSE 120 mg, CM 8 mg, Atr 0.24 mg |
| PSE 120 mg, CM 8 mg, Atr 0.12 mgAlso: Pseudoephedrine, chlorpheniramine (Chlor-Trimeton), atropinePseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 mg white, scored, tablets with "M27" on scored side and plain on the other side | Drug | PSE 120 mg, CM 8 mg, Atr 0.12 mg |
| PSE 120 mg, CM 8 mgAlso: Pseudoephedrine, chlorpheniramine (Chlor-Trimeton)Pseudoephedrine 120 mg, chlorpheniramine 8 mg tablets dosed BID | Drug | PSE 120 mg, CM 8 mg |
| Atropine 0.24 mgAlso: atropine sulfateAtropine sulfate 0.24 mg white, scored, tablets with "M27" on scored side and plain on the other side | Drug | Atropine 0.24 mg |
Primary outcome
Dose-ranging data for atropin
Time frame: 7.5 days
To provide dose-ranging data for atropine and select a dose of Atropine for Phase 3 clinical development using Total Nasal Symptom Score (TNSS) as the primary endpoint plus recording of adverse events
1 secondary outcome
Establish effect size for determining power and TNSS efficacy endpoint
Time frame: 7.5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
Related trials for Rhinitis, Seasonal, Allergic
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
RecruitingPhase 1
Phase 1, First in Human (FIH), Open-Label, Single-Arm, Ascending Dose Study to Assess the Safety, Tolerability and Preliminary Immunogenicity of ITI-9001 in Japanese Patients With Japanese Red Cedar (JRC) Pollinosis
Allergen Immunotherapy
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.
Stephen J Pollard, MD principal investigator
Family Allergy and Asthma
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PSE 120 mg, CM 8 mg, Atr 0.36 mg, PSE 120 mg, CM 8 mg, Atr 0.24 mg and PSE 120 mg, CM 8 mg, Atr 0.12 mg in people with Rhinitis, Seasonal, Allergic, run by Magna Pharmaceuticals, Inc. at 4 sites in United States.
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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 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?
Results are not available in the source record.
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?
Dose-ranging data for atropin (time frame: 7.5 days). 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 30 May 2014; AzTrials last refreshed its copy on 27 Oct 2026.