A double-blind, randomised, placebo-controlled study of roxithromycin and doxycycline combination, roxithromycin alone, or matching placebo for 12 weeks in adults with frequent exacerbations of chronic obstructive pulmonary disease

In adults with frequent exacerbations of chronic obstructive pulmonary disease, does roxithromycin alone or in combination with doxycycline for 12 weeks, compared with matching placebo, reduce rate of exacerbations?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000052538

Acronym

INSPIRE

Enrollment

312

Registered

2015-01-22

Start date

2000-07-06

Completion date

2002-07-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study was to determine whether prophylactic antibiotic therapy reduced the number and seriousness of respiratory illnesses of these patients suffer due to their chronic obstructive pulmonary disease.

Interventions

Arm 1: oral tablet roxithromycin 300mg once daily and oral tablet doxycycline 100mg placebo once daily for 12 weeks. Arm 2: oral tablet roxithromycin 300mg once daily and oral tablet doxycycline 100mg once daily for 12 weeks. Arm 3: oral tablet roxithromycin 300mg placebo once daily and oral tablet doxycycline 100mg placebo once daily for 12 weeks. Mode and type of administration = oral tablets. Compliance was assessed by tablet counts. Subjects were instructed to bring their study medication

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

45 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects aged 45 years or older; Meeting spirometric criteria for COPD (FEV1 less than or equal to 70% of predicted, ratio of FEV1 over FVC (FEV1/FVC) greater than or equal to 60%, reversibility of less than or equal to10% of predicted FEV1 or less than or equal to 200ml if predicted FEV1 less than or equal to 2L); Smoking history greater than or equal to 20 pack years; At least three confirmed moderate or severe COPD exacerbations in the past two years (i.e. requiring treatment with antibiotics and/or oral corticosteroids and/or hospitalisation); Positive serology for C. pneumoniae (IgG antibody titre greater than or equal to 1:64).

Exclusion criteria

Pulmonary disease other than COPD; Treatment with antibiotics, exacerbation or an investigational drug in the four weeks before randomisation; Pregnancy (serum pregnancy test) or breast feeding; History of hypersensitivity to macrolides, tetracyclines, beta-lactams or sulfamethoxazole:trimethoprim; Serious cardiovascular, hepatic, renal or other systemic diseases; Known long QT syndrome or corrected QT interval (QTc) greater than 450ms, sick sinus syndrome, bradycardia (less than 50 beats per minute) or severe hypokalaemia; Epilepsy; Treatment with medicine known to have important interaction with macrolides or tetracyclines; Impaired hepatic function (aspartate aminotransferase or alanine aminotransferase greater than or equal to 2 times of the upper limit of normal (ULN), alkaline phosphatase greater than or equal to 1.25 times the ULN, bilirubin greater than 2 times the ULN and albumin less than 30g/L); Or unlikely to comply.

Outcome results