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Intrapleural Minocycline After Simple Aspiration for the Prevention of Primary Spontaneous Pneumothorax

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00418392
First received: December 31, 2006
Last updated: December 13, 2012
Last verified: November 2012
History of Changes
  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:

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: December 2012
Primary Completion Date: April 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:

  1. Male or female.
  2. Age between 15 and 40 years old.
  3. First episode of spontaneous pneumothorax.
  4. Symptomatic (dyspnea or chest pain) or the rim of air is > 2cm on CXR requiring simple aspiration
  5. Complete or nearly complete and persistent lung expansion immediately following manual aspiration

  6. 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
  7. Written inform consent

Exclusion Criteria:

  1. With underlying pulmonary disease (asthma, chronic obstructive pulmonary disease, bronchiectasis, etc)
  2. With hemothorax or tension pneumothorax requiring chest tube insertion or operation
  3. A history of previous pneumothorax
  4. A history of previous ipsilateral thoracic operation
  5. Allergy to tetracycline or minocycline
  6. Pregnant or lactating patients.

  7. 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: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 65178 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Taiwan University Hospital
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: December 13, 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 21, 2013