Seasonal Allergic RhinitisAUTO-ACUSARNCT01271595
AUTO-ACUSAR - Effects of Acupuncture on the Autonomic Nervous System in Seasonal Allergic Rhinitis Patients
A study of Seasonal Allergic Rhinitis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
There is inconclusive evidence whether acupuncture treatment is effective in the treatment of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in SAR are only poorly understood. Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to May 2011
- Phase
- Interventional
- 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female or male patients (aged 16-45 years) with seasonal allergic rhinitis, clinically positive and test positive (skin-prick test and/or RAST) to grass and birch pollen
- Patients with >2 years of moderate to severe SAR
- Positive skin-prick test and/or RAST (at least class 2) results
- Visual analogue scale >40mm and <80 mm for SAR symptoms during the past year
- Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication
- Use of, or indication for, oral antihistamines as anti-allergic medication
- Written informed consent
Who cannot join
- Perennial SAR or other types of chronic rhinitis
- Allergic asthma and/or moderate to severe atopic dermatitis
- Active tuberculosis
- Auto-immune disorders
- Severe chronic inflammatory diseases
- History of anaphylactic reactions
Show all 17Show fewer
- Hypersensitivity to Rescue medication or related drugs used in study related drugs
- Specific immunotherapy >3 years
- Simultaneous participation in other clinical trials
- Serious acute or chronic organic disease or mental disorder
- Pregnancy or breast feeding
- Allergy desensitisation therapy (current, during the past two years, or planned in the next two years)
- Blood coagulation disorder and/or current use of anticoagulants
- Previous acupuncture treatment for SAR
- Any Complementary and alternative medicine treatment at the moment, in the last three months or planned in the next two years
- intake of Beta-Blocker Medication
- use of pacemaker
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
Berlin, 10117
About this study
Official title: Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR
There is inconclusive evidence whether acupuncture treatment is effective in the treatment of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic function in a sub-group of ACUSAR patients. Baseline values were compared to data from matched healthy controls.
Read the detailed description
In AUTO-ACUSAR a subsample of ACUSAR patients from acupuncture or sham acupuncture groups were included. Tests of autonomic functions included measurement of heart rate variability during paced breathing, blood pressure, heart rate and salivary alpha amylase response to a cold pressure test (CPT) and cortisol awakening response before the first and the last of twelve treatment sessions. Healthy matched controls underwent the same measurement once only
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- sham acupuncture
- Keywords
- acupuncture, autonomic nervous system, seasonal allergic rhinitis
- 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.
sham acupunctureOther
Also called acupuncture
12 sessions of sham acupuncture over 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Active comparator | 12 sessions of acupuncture according to TCM Receives: Other: sham acupuncture |
| sham acupuncture | Sham comparator | superficial acupuncture at non acupuncture sites Receives: Other: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
RMSSD, LF, HF, HR, blood pressure
Measured: 8 weeks
Secondary outcomes (1)
Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)
Measurements were taken during the experimental setting 3 times , CAR by the patients the day before first and last acupuncture
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionMay 2011
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.
- More trials run by Charite University, Berlin, GermanyThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benno Brinkhaus, Charite University, Berlin, Germany
- Investigators
- Benno Brinkhaus, Prof. Dr., Principal investigator, Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271595
- Sponsor's protocol ID
- EA1/214/07a
- Acronym
- AUTO-ACUSAR
- Status last verified
- Nov 2018
- First submitted
- 23 Dec 2010
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Seasonal Allergic Rhinitis- Effects on the Autonomic Nervous System (AUTO-ACUSAR)- an Explorative Substudy of ACUSAR
- ClinicalTrials.gov ID
- NCT01271595
- Acronym / sponsor ID
- AUTO-ACUSAR / EA1/214/07a
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- acupuncture, autonomic nervous system, seasonal allergic rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 7 Jan 2011 (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.
There is inconclusive evidence whether acupuncture treatment is effective in the treatment of seasonal allergic rhinitis (SAR). Furthermore, the underlying mechanisms of acupuncture in SAR are only poorly understood. It was hypothesised that the therapeutic mechanism of acupuncture is related to changes in autonomic function. AUTO-ACUSAR is a sub-study of the DFG-funded three-arm randomized controlled trial ACUSAR trial investigating the efficacy of acupuncture vs. sham acupuncture vs. rescue medication in SAR. The aim of AUTO-ACUSAR was to investigate short and long-term effects of acupuncture vs. sham acupuncture on autonomic function in a sub-group of ACUSAR patients. Baseline values were compared to data from matched healthy controls.
Detailed description
In AUTO-ACUSAR a subsample of ACUSAR patients from acupuncture or sham acupuncture groups were included. Tests of autonomic functions included measurement of heart rate variability during paced breathing, blood pressure, heart rate and salivary alpha amylase response to a cold pressure test (CPT) and cortisol awakening response before the first and the last of twelve treatment sessions. Healthy matched controls underwent the same measurement once only
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Active comparator | Other: sham acupuncture12 sessions of acupuncture according to TCM |
| sham acupuncture | Sham comparator | Other: sham acupuncturesuperficial acupuncture at non acupuncture sites |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Female or male patients (aged 16-45 years) with seasonal allergic rhinitis, clinically positive and test positive (skin-prick test and/or RAST) to grass and birch pollen
- Patients with >2 years of moderate to severe SAR
- Positive skin-prick test and/or RAST (at least class 2) results
- Visual analogue scale >40mm and <80 mm for SAR symptoms during the past year
- Patients must be able to complete a diary for self-evaluation of symptoms and recording use of anti-symptomatic medication
Key exclusion criteria (17 listed)
- Perennial SAR or other types of chronic rhinitis
- Allergic asthma and/or moderate to severe atopic dermatitis
- Active tuberculosis
- Auto-immune disorders
- Severe chronic inflammatory diseases
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 |
|---|---|---|
| sham acupunctureAlso: acupuncture12 sessions of sham acupuncture over 8 weeks | Other | acupuncture, sham acupuncture |
Primary outcome
Heart Rate Variability
Time frame: 8 weeks
RMSSD, LF, HF, HR, blood pressure
1 secondary outcome
Salivary Amylase and Cortisol, Cortisol Awakening Response (CAR)
Time frame: 8 weeks
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 20 Nov 2018.
Related trials for Seasonal Allergic Rhinitis
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch 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
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
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
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.
Benno Brinkhaus, Prof. Dr. principal investigator
Institute for Socialmedicine, Epidemiology and Health Economics, Charité University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Seasonal Allergic Rhinitis, run by Charite University, Berlin, Germany at 1 site in Germany.
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 7 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 20 Nov 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 Germany. 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.
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?
Heart Rate Variability (time frame: 8 weeks). 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 20 Nov 2018.