Clinical trial NCT02033252: Acupuncture for Rhinitis Complicated With Asthma
Official title: Acupuncture for Persistent Allergic Rhinitis Complicated With Asthma, A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Rhinitis
Asthma
Lead sponsor: Korean Medicine Hospital of Pusan National University
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled study aimed to evaluate the efficacy and safety of acupuncture therapy on persistent allergic rhinitis patients complicated with asthma.


Eligibility criteria: Inclusion Criteria:

1. Suffering from persistent Allergic rhinitis (PAR; nasal obstruction, rhinorrhoea, sneezing and nasal itching) symptoms for more than 4 days/week, and greater than 4 consecutive weeks.
2. Moderate-severe symptoms according to Allergic rhinitis and its impact on asthma (ARIA) criteria.
3. Positive reaction for more than or equal to one respiratory allergen (SPT or MAST)
4. Stable asthma symptoms with diagnosis of Asthma by respiratory or allergic disease specialist.
5. No changes in asthma or allergic rhinitis drugs for the past month
6. Aged greater than or equal to 18 years, either sex.
7. No problem with expression of opinion
8. Provided with written consent
9. No other disease except allergic rhinitis or asthma which could affect the disease.

Exclusion Criteria:

1. Having experience using ventilator due to exacerbation of asthma symptoms within six months.
2. Experience of acute respiratory tract infection treated with antibiotics within 14 days
3. Having anatomical occlusion or deformation in nasal cavity.
4. Signs of infection in chest X-ray or having active respiratory disease except asthma
5. Below or equal to 4 on Total nasal symptom score (TNSS) in the latest week.
6. Received drugs affecting directly to allergic rhinitis such as H1-antihistamines, decongestants (nasal, oral or ocular), corticosteroids within 14 days.
7. Received following treatments for allergic rhinitis or asthma within six months ; Traditional Korean medicine interventions such as acupuncture, moxibustion, cupping therapy and herbal medication inhalation or CAM including homeopathy.
8. Received herbal medication for allergic rhinitis or asthma within 14 days.
9. Pregnant, planning the pregnancy or breast-feeding
10. Tuberculosis, hepatitis or more than 2 x normal limit of serum creatinine, aspartate aminotransferase/alanine aminotransferase (AST/ALT).
11. Skin lesion on acupoint or other systemic disease insufficient for acupuncture.
12. Night-shift workers staying up all night
13. Who cannot participate clinical trial properly.

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: Change from Baseline TNSS Score at 4 Weeks after Randomization
Secondary outcomes:
measure: Rhinitis Quality of Life Questionnaire (RQLQ)
timeFrame: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
measure: Quality of Life Questionnaire for adult Korean Asthmatics (QLQAKA)
timeFrame: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
measure: Visual Analogue Scale
timeFrame: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 4 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
measure: Pulmonary function test (PFT)
timeFrame: Baseline, four weeks after randomization (both groups)
measure: Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)
timeFrame: Baseline, four weeks after randomization
measure: Total Nasal Symptom Score (TNSS)
timeFrame: Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: National Clinical Research Center, Korean Medicine Hospital, Pusan National University
state: Kyungsangnamdo
Study officials:
affiliation: Korean Medicine Hospital, Pusan National University
name: Jun-Yong Choi, KMD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yangsan Pusan National University Hospital
name: Yun Seong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yangsan Pusan National University Hospital
name: Seung Eun Lee, MD
role: STUDY_DIRECTOR
References: