Cochrane · systematic review · CD001127

Dornase alfa for cystic fibrosis

Yang, C, Montgomery, M · Cochrane Database of Systematic Reviews · 2021 · Cochrane Library

Cystic Fibrosis and Genetic Disorders3 versionsAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
23
current version
GRADE rated
23
No studies
0
Included studies
NR
No studies 0 · 0%Ungraded 0 · 0%Very low 0 · 0%Low 18 · 78.3%Moderate 3 · 13%High 2 · 8.7%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Current version only

Dornase alfa versus placebo or no dornase alfa treatment

Population: Adults and children with cystic fibrosis
CD001127.PUB5 (current) · 7 questions
OutcomeEffectEvidenceStatus / GRADE
Relative mean percentage change in FEV1 (% predicted) at 3 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 320 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Relative mean percentage change in FEV1 (% predicted) at 6 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 647 participantsHigh
Relative mean percentage change in FVC (% predicted) at 3 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 318 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Relative mean percentage change in FVC (% predicted) at 6 months
Dornase alfa vs placebo or no dornase alfa treatment
MD 3.8 [2.62, 4.98]1 study · 647 participantsHigh
Change in quality of life ‐ CFQ‐R respiratory at 1 month
Dornase alfa vs placebo or no dornase alfa treatment
MD 0.8419 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Change in quality of life ‐ CFQ‐R respiratory (parent) at 1 month
Dornase alfa vs placebo or no dornase alfa treatment
MD 9.7819 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Number of people experiencing exacerbations at up to 2 years
Dornase alfa vs placebo or no dornase alfa treatment
RR 0.78 [0.62, 0.96]3 studies · 1157 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias

Dornase alfa daily versus alternate days

Population: Children with cystic fibrosis
CD001127.PUB5 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean relative percentage change in FEV1 (L) at 3 months
Dornase alfa daily vs alternate days
MD 243 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in FVC (L) at 3 months
Dornase alfa daily vs alternate days
MD 0.0343 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in quality of life score at 3 months
Dornase alfa daily vs alternate days
MD 0.0143 participantsLow
Downgraded: risk of bias, indirectness
Number of pulmonary exacerbations at 3 months
Dornase alfa daily vs alternate days
no estimate extracted43 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus hypertonic saline

Population: Children with cystic fibrosis
CD001127.PUB5 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean relative percentage in FEV1 (L) at 3 months
Dornase alfa vs hypertonic saline
MD 8 [2, 14]431 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in FVC (L) at 3 months
Dornase alfa vs hypertonic saline
MD 0.08431 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in quality of life score at 3 months
Dornase alfa vs hypertonic saline
MD 0.03431 participantsLow
Downgraded: risk of bias, indirectness
Number of pulmonary exacerbations at 3 months
Dornase alfa vs hypertonic saline
no estimate extracted431 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus mannitol

Population: Children with cystic fibrosis
CD001127.PUB5 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean absolute change in FEV1 (L) at 3 months
Dornase alfa vs mannitol
MD 0.02231 participantsLow
Downgraded: risk of bias, indirectness
Mean absolute change in FVC (L) at 3 months
Dornase alfa vs mannitol
no estimate extracted231 participantsLow
Downgraded: risk of bias, indirectness
Change in quality of life ‐ CFQ‐R at 3 months
Dornase alfa vs mannitol
MD 10.61 [0.27, 20.95]231 participantsLow
Downgraded: risk of bias, indirectness
Number of people experiencing exacerbations ‐ at 3 months
Dornase alfa vs mannitol
RR 1.1 [0.25, 4.84]231 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus dornase alfa and mannitol

Population: Children with cystic fibrosis
CD001127.PUB5 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean absolute change in FEV1 (L) at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 0.1231 participantsLow
Downgraded: risk of bias, indirectness
Mean absolute change in FVC (L) at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 0.13231 participantsLow
Downgraded: risk of bias, indirectness
Change in quality of life ‐ CFQ‐R at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 10.61 [0.27, 20.95]231 participantsLow
Downgraded: risk of bias, indirectness
Number of people experiencing exacerbations at 3 months
Dornase alfa vs dornase alfa and mannitol
RR 0.55 [0.16, 1.92]231 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus placebo or no dornase alfa treatment

Population: Adults and children with cystic fibrosis
CD001127.PUB4 · 7 questions
OutcomeEffectEvidenceStatus / GRADE
Relative mean percentage change in FEV1 (% predicted) at 3 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 320 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Relative mean percentage change in FEV1 (% predicted) at 6 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 647 participantsHigh
Relative mean percentage change in FVC (% predicted) at 3 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 318 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Relative mean percentage change in FVC (% predicted) at 6 months
Dornase alfa vs placebo or no dornase alfa treatment
MD 3.8 [2.62, 4.98]1 study · 647 participantsHigh
Change in quality of life ‐ CFQ‐R respiratory at 1 month
Dornase alfa vs placebo or no dornase alfa treatment
MD 0.8419 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Change in quality of life ‐ CFQ‐R respiratory (parent) at 1 month
Dornase alfa vs placebo or no dornase alfa treatment
MD 9.7819 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Number of people experiencing exacerbations at up to 2 years
Dornase alfa vs placebo or no dornase alfa treatment
RR 0.78 [0.62, 0.96]3 studies · 1157 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias

Dornase alfa daily versus alternate days

Population: Children with cystic fibrosis
CD001127.PUB4 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean relative percentage change in FEV1 (L) at 3 months
Dornase alfa daily vs alternate days
MD 243 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in FVC (L) at 3 months
Dornase alfa daily vs alternate days
MD 0.0343 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in quality of life score at 3 months
Dornase alfa daily vs alternate days
MD 0.0143 participantsLow
Downgraded: risk of bias, indirectness
Number of pulmonary exacerbations at 3 months
Dornase alfa daily vs alternate days
no estimate extracted43 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus hypertonic saline

Population: Children with cystic fibrosis
CD001127.PUB4 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean relative percentage in FEV1 (L) at 3 months
Dornase alfa vs hypertonic saline
MD 8 [2, 14]431 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in FVC (L) at 3 months
Dornase alfa vs hypertonic saline
MD 0.08431 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in quality of life score at 3 months
Dornase alfa vs hypertonic saline
MD 0.03431 participantsLow
Downgraded: risk of bias, indirectness
Number of pulmonary exacerbations at 3 months
Dornase alfa vs hypertonic saline
no estimate extracted431 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus mannitol

Population: Children with cystic fibrosis
CD001127.PUB4 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean absolute change in FEV1 (L) at 3 months
Dornase alfa vs mannitol
MD 0.02231 participantsLow
Downgraded: risk of bias, indirectness
Mean absolute change in FVC (L) at 3 months
Dornase alfa vs mannitol
no estimate extracted231 participantsLow
Downgraded: risk of bias, indirectness
Change in quality of life ‐ CFQ‐R at 3 months
Dornase alfa vs mannitol
MD 10.61 [0.27, 20.95]231 participantsLow
Downgraded: risk of bias, indirectness
Number of people experiencing exacerbations ‐ at 3 months
Dornase alfa vs mannitol
RR 1.1 [0.25, 4.84]231 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus dornase alfa and mannitol

Population: Children with cystic fibrosis
CD001127.PUB4 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean absolute change in FEV1 (L) at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 0.1231 participantsLow
Downgraded: risk of bias, indirectness
Mean absolute change in FVC (L) at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 0.13231 participantsLow
Downgraded: risk of bias, indirectness
Change in quality of life ‐ CFQ‐R at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 10.61 [0.27, 20.95]231 participantsLow
Downgraded: risk of bias, indirectness
Number of people experiencing exacerbations at 3 months
Dornase alfa vs dornase alfa and mannitol
RR 0.55 [0.16, 1.92]231 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus placebo or no dornase alfa treatment

Population: Adults and children with cystic fibrosis
CD001127.PUB3 · 6 questions
OutcomeEffectEvidenceStatus / GRADE
Relative mean percentage change in FEV1 (% predicted) at 3 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 320 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Relative mean percentage change in FEV1 (% predicted) at 6 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 647 participantsHigh
Relative mean percentage change in FVC (% predicted) at 3 months
Dornase alfa vs placebo or no dornase alfa treatment
no estimate extracted1 study · 318 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Change in quality of life ‐ CFQ‐R respiratory at 1 month
Dornase alfa vs placebo or no dornase alfa treatment
MD 0.8419 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Change in quality of life ‐ CFQ‐R respiratory (parent) at 1 month
Dornase alfa vs placebo or no dornase alfa treatment
MD 9.7819 participantsLow
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias
Number of people experiencing exacerbations at up to 2 years
Dornase alfa vs placebo or no dornase alfa treatment
RR 0.78 [0.62, 0.96]3 studies · 1157 participantsModerate
Downgraded: risk of bias, imprecision, inconsistency, indirectness, publication bias

Dornase alfa daily versus alternate days

Population: Children with cystic fibrosis
CD001127.PUB3 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean relative percentage change in FEV1 (L) at 3 months
Dornase alfa daily vs alternate days
MD 243 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in FVC (L) at 3 months
Dornase alfa daily vs alternate days
MD 0.0343 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in quality of life score at 3 months
Dornase alfa daily vs alternate days
MD 0.0143 participantsLow
Downgraded: risk of bias, indirectness
Number of pulmonary exacerbations at 3 months
Dornase alfa daily vs alternate days
no estimate extracted43 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus hypertonic saline

Population: Children with cystic fibrosis
CD001127.PUB3 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean relative percentage in FEV1 (L) at 3 months
Dornase alfa vs hypertonic saline
MD 8 [2, 14]431 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in FVC (L) at 3 months
Dornase alfa vs hypertonic saline
MD 0.08431 participantsLow
Downgraded: risk of bias, indirectness
Mean relative percentage in quality of life score at 3 months
Dornase alfa vs hypertonic saline
MD 0.03431 participantsLow
Downgraded: risk of bias, indirectness
Number of pulmonary exacerbations at 3 months
Dornase alfa vs hypertonic saline
no estimate extracted431 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus mannitol

Population: Children with cystic fibrosis
CD001127.PUB3 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean absolute change in FEV1 (L) at 3 months
Dornase alfa vs mannitol
MD 0.02231 participantsLow
Downgraded: risk of bias, indirectness
Mean absolute change in FVC (L) at 3 months
Dornase alfa vs mannitol
no estimate extracted231 participantsLow
Downgraded: risk of bias, indirectness
Change in quality of life ‐ CFQ‐R at 3 months
Dornase alfa vs mannitol
MD 10.61 [0.27, 20.95]231 participantsLow
Downgraded: risk of bias, indirectness
Number of people experiencing exacerbations ‐ at 3 months
Dornase alfa vs mannitol
RR 1.1 [0.25, 4.84]231 participantsLow
Downgraded: risk of bias, indirectness

Dornase alfa versus dornase alfa and mannitol

Population: Children with cystic fibrosis
CD001127.PUB3 · 4 questions
OutcomeEffectEvidenceStatus / GRADE
Mean absolute change in FEV1 (L) at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 0.1231 participantsLow
Downgraded: risk of bias, indirectness
Mean absolute change in FVC (L) at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 0.13231 participantsLow
Downgraded: risk of bias, indirectness
Change in quality of life ‐ CFQ‐R at 3 months
Dornase alfa vs dornase alfa and mannitol
MD 10.61 [0.27, 20.95]231 participantsLow
Downgraded: risk of bias, indirectness
Number of people experiencing exacerbations at 3 months
Dornase alfa vs dornase alfa and mannitol
RR 0.55 [0.16, 1.92]231 participantsLow
Downgraded: risk of bias, indirectness