Acupuncture for Rhinitis Complicated With Asthma

Acupuncture for Persistent Allergic Rhinitis Complicated With Asthma, A Randomized Controlled Pilot Trial

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

Study Overview

• Status: Unknown
• Conditions: Asthma; Allergic Rhinitis
• Intervention / Treatment: Device: Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyungsangnamdo
    • Yangsan, Kyungsangnamdo, Korea, Republic of, 626-770
      • Recruiting
      • National Clinical Research Center, Korean Medicine Hospital, Pusan National University
      • Contact: Dong Jin Kim, BcS; Phone Number: 82553605902; Email: djkim085@gmail.com
      • Principal Investigator: Jun Yong Choi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; A series of acupuncture sessions within four weeks from the baseline with concurrent conventional medications for asthma	Device: Acupuncture; In the acupuncture treatment group, 10 acupuncture points (bilateral LI4, TE23, ST36, unilateral EHN-1, GV23, LI20 and LI4) will be inserted with 0.20 mm in diameter x 30 mm in length disposal needles. The needle will be inserted to a depth of 10 - 30 mm, according to the points selected. The participating acupuncture doctors will manually manipulate the acupuncture needles with de-qi sensation and maintain the needles for 10 minutes with two times of manual stimulation, at the beginning and at the end.
No Intervention: Waiting; Participants who will be allocated to waitlist will receive no acupuncture treatments throughout the 4 weeks while receiving other conventional managements for asthma. After 4 weeks, if participants choose to try the acupuncture treatment, the active acupuncture treatment will be provided for 4 weeks (3 sessions/week).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Nasal Symptom Score (TNSS)	Change from Baseline TNSS Score at 4 Weeks after Randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Rhinitis Quality of Life Questionnaire (RQLQ)	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)
Quality of Life Questionnaire for adult Korean Asthmatics (QLQAKA)	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)
Visual Analogue Scale	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)
Pulmonary function test (PFT)	Baseline, four weeks after randomization (both groups)
Euro Quality of Life-5 Dimention Questionnaire (EQ-5D)	Baseline, four weeks after randomization
Total Nasal Symptom Score (TNSS)	Change from Baseline at 2 Weeks after Randomization (Both Groups), Change from Baseline at 8 Weeks after Randomization (Active Group Only)

Collaborators and Investigators

• Sponsor: Jun-Yong Choi
• Investigators: Principal Investigator: Jun-Yong Choi, KMD, PhD, Korean Medicine Hospital, Pusan National University; Principal Investigator: Yun Seong Kim, MD, PhD, Yangsan Pusan National University Hospital; Study Director: Seung Eun Lee, MD, Yangsan Pusan National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Asthma; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: NCRC-KIM-02