Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax - Full Text View

Sponsor:	National Taiwan University Hospital
Information provided by (Responsible Party):	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00418392

Purpose

The estimated recurrence rate of primary spontaneous pneumothorax is 23-50% after the first episode, and the optimal treatment remains unknown. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as first line treatment for all primary pneumothoraces requiring intervention. However, the 1 year recurrence rate of this procedure was as high as 25-30%, making it inappropriate as a standard of care.

Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to shorten the duration of air leaks and reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Many chemical irritants (tetracycline, talc, and minocycline) have been used to decrease the rate of recurrence in spontaneous pneumothorax. Tetracycline, which was the most commonly used irritant, is no longer available. Talc insufflation of the pleural cavity is safe and effective for primary spontaneous pneumothorax. However, it should be applied either with surgical or medical thoracoscopy. Minocycline, a derivative of tetracycline, is as effective as tetracycline in inducing pleural fibrosis in rabbits. In the previous studies, we have shown that additional minocycline pleurodesis is a safe and convenient procedure to decrease the rates of ipsilateral recurrence after thoracoscopic treatment of primary spontaneous pneumothorax. In the present study, additional minocycline pleurodesis will be randomly administered in patients with first episode of primary spontaneous pneumothorax after simple aspiration to test if it can reduce the rate of recurrence.

Condition	Intervention	Phase
Pneumothorax	Procedure: Simple aspiration with minocycline pleurodesis Procedure: simple aspiration	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax: A Randomized Trial

Resource links provided by NLM:

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:

to compare the rates of ipsilateral recurrence between the minocycline and observation groups after simple aspiration of the pneumothorax. [ Time Frame: 12 months after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety profile of minocycline pleurodesis [ Time Frame: 12 months after treatment ] [ Designated as safety issue: Yes ]
Early results, including immediate success rates, one-week success rates, complication rates, rates of hospitalization, duration of hospitalization, and the degrees of chest pain. [ Time Frame: 7 days after treatment ] [ Designated as safety issue: Yes ]
Long-term effects of minocycline pleurodesis, including degrees of residual chest pain and pulmonary function test [ Time Frame: 12 months after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	November 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Minocycline group After successful simple aspiration, minocycline pleurodesis will be performed.	Procedure: Simple aspiration with minocycline pleurodesis Intrapleural instillation of 300mg minocycline within 5 min after simple aspiration
Placebo Comparator: Control group After successful simple aspiration, nothing will be performed.	Procedure: simple aspiration Simple aspiration for primary spontaneous pneumothorax by pigtail catheter

Show Detailed Description

Eligibility

Ages Eligible for Study:	15 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female.
Age between 15 and 40 years old.
First episode of spontaneous pneumothorax.
Symptomatic (dyspnea or chest pain) or the rim of air is > 2cm on CXR requiring simple aspiration
Complete or nearly complete and persistent lung expansion immediately following manual aspiration
Organ Function Requirements:
- Adequate hematological function (Hb > 10 g/dl, ANC > 1.5 x 109/L, platelets > 100 x 109/L)
- Normal renal and hepatic functions: serum creatinine < 1 x ULN, SGPT and SGOT< 2.5 x ULN, alkaline phosphatase < 5 x ULN
Written inform consent

Exclusion Criteria:

With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc)
With hemothorax or tension pneumothorax requiring chest tube insertion or operation
A history of previous pneumothorax
A history of previous ipsilateral thoracic operation
Allergy to tetracycline or minocycline
Pregnant or lactating patients.
Other serious concomitant illness or medical conditions:
- Congestive heart failure or unstable angina pectoris.
- History of myocardial infarction within 1 year prior to the study entry.
- Uncontrolled hypertension or arrhythmia.
- History of significant neurologic or psychiatric disorders, including dementia or seizure.
- Active infection requiring i.v. antibiotics.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418392

Contacts

Contact: Yung-Chie Lee, MD, PhD	886-2-23123456 ext 5070	yclee@ntuh.gov.tw
Contact: Jin-Shing Chen, MD, PhD	886-2-23123456 ext 5178	chenjs@ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 65178 chenjs@ntu.edu.tw
Principal Investigator: Yung-Chie Lee, MD, PhD
Sub-Investigator: Jin-Shing Chen, MD, PhD
Sub-Investigator: Kuang-Chau Tsai, MD
Sub-Investigator: Wen-Jone Chen, MD, PhD

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Study Chair:

Yung-Chie Lee, MD, PhD

National Taiwan University Hospital

More Information

Publications:

Chen JS, Hsu HH, Chen RJ, Kuo SW, Huang PM, Tsai PR, Lee JM, Lee YC. Additional Minocycline Pleurodesis after Thoracoscopic Surgery for Primary Spontaneous Pneumothorax. Am J Respir Crit Care Med. 2005 Dec 15; [Epub ahead of print]

Chen JS, Hsu HH, Kuo SW, Tsai PR, Chen RJ, Lee JM, Lee YC. Effects of additional minocycline pleurodesis after thoracoscopic procedures for primary spontaneous pneumothorax. Chest. 2004 Jan;125(1):50-5.

Light RW, O'Hara VS, Moritz TE, McElhinney AJ, Butz R, Haakenson CM, Read RC, Sassoon CS, Eastridge CE, Berger R, et al. Intrapleural tetracycline for the prevention of recurrent spontaneous pneumothorax. Results of a Department of Veterans Affairs cooperative study. JAMA. 1990 Nov 7;264(17):2224-30.

Henry M, Arnold T, Harvey J; Pleural Diseases Group, Standards of Care Committee, British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax. 2003 May;58 Suppl 2:ii39-52. No abstract available.

Responsible Party:	National Taiwan University Hospital, Director, National Clinical Trial and Research Center
ClinicalTrials.gov Identifier:	NCT00418392 History of Changes
Other Study ID Numbers:	950510, DOH95-TD-I-111-012
Study First Received:	December 31, 2006
Last Updated:	February 8, 2012
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

pneumothorax, aspiration, minocycline, pleurodesis

Additional relevant MeSH terms:

Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
Minocycline

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2012